WQ0034603_Renewal Application_20220207

Non -Discharge Branch Upload/Submittal Form
NORTH CAROLINA
EnvironmentalQuul1ty
Version 2 - Revised June 23, 2020
Initial Review
Reviewer
EADS\ndthornburg
Is this submittal an application? (Excluding additional information.) *
Yes No
Permit Number (IR) * WQ0034603
Applicant/Permittee Segirus, Inc.
Applicant/Permittee Address 475 Green Oaks Parkway Holly Springs, NC 27540-5299
Is the owner in BIMS? Yes No Is the facility in BIMS? Yes No
Owner Type Organization
Facility Name Segirus, Inc
County Wake
Fee Category Major Fee Amount $0
Is this a complete application?*
Yes No
Signature Authority
Signature Authority Title
Signature Authority Email
Document Type (if non -application)
Email Notifications
Does this need review by the hydrogeologist?* Yes No
Regional Office
CO Reviewer
Admin Reviewer
Complete App Date 02/07/2022
Below list any additional email address that need notification about a new project.
Email Address
Comments to be added to email notfication
Comments for Admin
Comments for RO

Comments for Reviewer
Comments for Applicant

Submittal Form
Project Contact Information
Please provide information on the person to be contacted by NDB Staff regarding electronic submittal, confirmation of receipt, and other correspondence.
Name*
Anne Marie Baese
Email Address*
[e-mail]
Project Information
Application/Document Type*
New (Fee Required)
Modification - Major (Fee Required)
Renewal with Major Modification (Fee
Required)
Annual Report
Additional Information
Other
Phone Number*
919-324-4910
O Modification - Minor
O Renewal
O GW-59, NDMR, NDMLR, NDAR-1,
NDAR-2
O Residual Annual Report
O Change of Ownership
We no longer accept these monitoring reports through this portal. Please click on the link below and it will take you to the correct form.
https://edocs.deg.nc.gov/Forms/NonDischarge_Monitoring_Report
Permit Type: *
Permit Number:*
Applicant/Permittee *
Wastewater Irrigation
Other Wastewater
Closed -Loop Recycle
Single -Family Residence Wastewater
Irrigation
Segirus, Inc.
High -Rate Infiltration
• Reclaimed Water
Residuals
Other
WQ0034603
Has Current Existing permit number
Applicant/Permittee Address* 475 Green Oaks Parkway Holly Springs, NC 27540-5299
Facility Name*
Segirus Reclaimed Water System
Please provide comments/notes on your current submittal below.
Please also cc [e-mail] and [e-mail] on any email
correspondence related to this permit renewal application (application was received, review is
in progress, renewal has been approved, etc...) Thank you!
At this time, paper copies are no longer required. If you have any questions about what is required, please contact Nathaniel Thornburg
at [e-mail].
Please attach all information required or requested for this submittal to be reviewed here. *
(Application Form, Engineering Plans, Specifications, Calculations, Etc.)
Final Segirus Reclaimed Water Permit Renewal
Application.pdf
Upload only 1 PDF document (less than 250 MB). Multiple documents must be combined into one PDF file unless file is larger
than upload limit.
* ✓
14.14MB
By checking this box, I acknowledge that I understand the application will not be
accepted for pre -review until the fee (if required) has been received by the Non -
Discharge Branch. Application fees must be submitted by check or money order and
made payable to the North Carolina Department of Environmental Quality (NCDEQ).
I also confirm that the uploaded document is a single PDF with all parts of the
application in correct order (as specified by the application).
Mail payment to:
NCDEQ — Division of Water Resources
Attn: Non -Discharge Branch
1617 Mail Service Center
Raleigh, NC 27699-1617

Signature
Submission Date 2/7/2022

D
R,
State of North Carolina
Department of Environmental Quality
Division of Water Resources
Divlslon of Water Resources 15A NCAC 02U — RECLAIMED WATER SYSTEM — RENEWAL
FORM: RWS-R 02-21
Pursuant to 15A NCAC 02T .0107(b), if the application does not include all required information and the necessary supporting
documentation, the application shall be returned. The application and attachments shall be prepared in accordance with 15A
NCAC 02T .0100, 15A NCAC 02U, and Division Policies. For more information, visit the Water Quality Permitting Section's
Non -Discharge Branch website. The Applicant shall submit an electronic copy of the application and attachments uploaded as
a single Portable Document Format (PDF) file to https://edocs.deq nc.Rov/Forms/NonDischarge-Branch-Submittal-Form-Ver2,
or emailed to Non-Discharge.Reports(a,ncdenr.gov if less than 20 megabytes (MB).
SECTION I— APPLICANT INFORMATION
1.
Applicant: Seqirus
2.
Permit No.: WQ0034603
3.
Signature authority: Robert Rezek
Phone number: (919) 455-359 Office
Title: Director of Environmental Health and Safety
Email: [e-mail]
4.
Mailing address: 475 Green Oaks Parkway
City: Holly Springs
State: NC Zip: 27540-5299
5.
Contact person: Anne Marie Baese
Primary phone number: [phone] Cell
Email: [e-mail]
Secondary phone number: [phone] Cell
SECTION II — FACILITY INFORMATION
Physical address: 475 Green Oaks Parkway
City: Holly Springs
Treatment facility coordinates to the sixth decimal degree:
Latitude: 35.653790° Longitude: -78.866534°
County: Wake Parcel No.: 0639914852
State: NC Zip: 27540-5299
Method: Geodetic quality GPS survey
SECTION III — FLOW INFATION
1.
Permitted flow: 33400 GPD (The maximum allowable flow based on what has been permitted)
2.
As -built flow: 155297 GPD (The maximum allowable flow based on what has been constructed)
3.
Average flow: 301 GPD (The average of all reported flows on the previous calendar year's NDMRs)
4.
Hydraulic capacity: .19 % (Divide the average flow in Item 3 by the As -built flow in Item 2)
5.
Wastewater composition: Domestic : % Industrial: 100 %
Stormwater:
%
SECTION IV — BILLING INFORMATION
. Billing address: 475 Green Oaks Parkway
City: Holly Springs
State: NC Zip: 27540-5299
. Verify the Applicant does not have any overdue annual fees:
https://deq.nc. gov/about/divisions/water-resources/water-resources-permits/wq-epayments
Pursuant to 15A NCAC 02T .0120(c), permits for renewing facilities shall not be granted if the Applicant or any affiliation has
an unpaid annual fee.
FORM: RWS-R 02-21
Page 1 of 6

SECTION V — OPERATOR IN RESPONSIBLE CHARGE (ORC) INFORMATION
(NOT APPLICABLE FOR CONJUNCTIVE SYSTEMS)
1. ORC: N/A Grade: N/A Certification No.: N/A
Mailing address:
City: State: Zip:
Phone number: ( ) Select Email:
2. Back -Up ORC: N/A Grade:
Mailing address:
City: State:
Phone number: ( ) - Select Email:
Certification No.:
Zip:
SECTION VI — OPEN -ATMOSPHERE STRUCTURES
1. List all open -atmosphere treatment and storage structures associated with the renewing permit. Attach additional sheets if
necessary.
Type
Select
Select
Select
Parcel No.
N/A
Select
Volume (gal)
0
Liner Type
Select
Select
Select
Freeboard (ft)
0
Latitude
.0°
°
Longitude
- .0°
Select
SECTION VII — RELATED PERMITS
. List all wastewater permits (i.e., sewer, collection system, NPDES, residuals) that have interactions with the renewing permit.
Attach additional sheets if necessary.
Permit Type
Permit No.
Select
Relationship Type
Select
Select
Select
Select
Select
Select
SECTION VIII — MONITORING WELLS
Select
1. List all groundwater monitoring wells associated with the renewing permit. Attach additional sheets if necessary.
Well Name
N/A
Parcel No.
N/A
Status
Select
Select
Select
Select
Select
Select
Select
Select
Select
Gradient
Select
Select
Select
Select
Select
Select
Select
Select
Select
Location
Select
Select
Select
Select
Select
Select
Select
Select
Select
Latitude
°
0
°
0
°
0
Longitude
0
°
Select
FORM: RWS-R 02-21
Select
Select
-
Page 2 of 6

SECTION IX — UTILIZATION FIELDS
1. List all utilization fields associated with the renewing permit. Attach additional sheets if necessary.
Field
N/A
County
N/A
Parcel No.
N/A
Deeded Owner
N/A
Area
0.00
Cover Crop
N/A
Latitude
.0°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
Longitude
- .0°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
°
Total Acreage:
FORM: RWS-R 02-21 Page 3 of 6

ATTACHMENT A — SITE MAP
Was the facility originally permitted or had a major modification issued after September 1, 2006?
® Yes — Pursuant to 15A NCAC 02T .0105(d), submit a site map pursuant to the requirements in I5A NCAC 02U .0201(d). These
requirements are:
El A scaled map of the site with topographic contour intervals not exceeding 10 feet or 25 percent of total site relief and showing
all facility -related structures and fences within 500 feet of the treatment, storage, and utilization areas.
❑ Soil mapping units shown on all utilization sites.
❑ Delineation of the compliance and review boundaries per 15A NCAC 02U .0501(a)(6).
❑ Setbacks as required by 15A NCAC 02U .0701.
® Site property boundaries within 500 feet of all treatment, storage, and utilization sites.
❑ No — Skip Attachment A.
ATTACHMENT B — SIGNATURE AUTHORITY DELEGATION
Does the signature authority in Section I, Item 3 meet the requirements pursuant to 15A NCAC 02T .0106(b)?
® Yes — Skip Attachment B.
❑ No — Submit a delegation letter pursuant to 15A NCAC 02T .0106(c) authorizing the signature authority to sign.
ATTACHMENT C — FLOW REDUCTION
Does the existing permit include an approved flow reduction?
❑ Yes — Submit a copy of the flow reduction approval letter, as well as the measured monthly average amount of wastewater flow
contributed per unit for the 12 months prior to permit renewal. If any of these monthly averages are within 20% of the approved
flow reduction value, the Permittee shall provide a reevaluation of the reduced flow value pursuant to the requirements in 15A
NCAC 02T .0114(f).
❑ No — Skip Attachment C.
ATTACHMENT D — CERTIFICATE OF PUBLIC CONVENIENCE AND NECESSITY
Is the Applicant a Privately -Owned Public Utility?
❑ Yes — Pursuant to 15A NCAC 02T .01I5(a)(I), submit the Certificate of Public Convenience and Necessity from the North
Carolina Utilities Commission demonstrating the Applicant is authorized to hold the utility franchise.
® No — Skip Attachment D.
ATTACHMENT E — OPERATIONAL AGREEMENT
Is the Applicant a Home/Property Owners' Association or Developer of Lots to be Sold?
❑ Yes (Home/Property Owners' Association) — Pursuant to 15A NCAC 02T .0115(a)(2), submit an executed Operational Agreement
(FORM: HOA). Pursuant to 15A NCAC 02T _01 I5(e), if the applicant is a legally formed Homeowners' or Property Owner's
Association, submit a copy of the Articles of Incorporation, Declarations, and By-laws.
❑ Yes (Developer of Lots to be Sold) — Pursuant to 15A NCAC 02T .0115(a)(2), submit an executed Operational. Agreement
(FORM: DEV). Pursuant to 15A NCAC 02T .0115(b), if the applicant is a developer of lots to be sold, submit a copy of the
Articles of Incorporation, Declarations, and By-laws.
® No — Skip Attachment E.
FORM: RWS-R 02-21
Page 4 of 6

ATTACHMENT F — DEMONSTRATION OF FUTURE WASTEWATER TREATMENT CAPACITIES
Is the applicant a municipality, county, sanitary district, or public utility?
❑ Yes — Proceed to the next question.
® No — Skip Attachment F.
Does the hydraulic capacity in Section III, Item 4 exceed 70%?
❑ Yes (the hydraulic capacity is greater than 70%, but less than 80%) — Pursuant to 15A NCAC 02T .0118(1), prior to exceeding
80 percent of the system's permitted hydraulic capacity (based on the average flow during the last calendar year), the permittee
shall submit an engineering evaluation of their future wastewater treatment, utilization, and disposal needs. This evaluation shall
outline plans for meeting future wastewater treatment, utilization, or disposal needs by either expansion of the existing system,
elimination or reduction of extraneous flows, or water conservation and shall include the source of funding for the improvements.
If expansion is not proposed or is proposed for a later date, a justification shall be made that wastewater treatment needs will be
met based on past growth records and future growth projections, and as appropriate, shall include conservation plans or other
measures to achieve waste flow reductions.
❑ Yes (the hydraulic capacity greater than 80%) — Proceed to the next question.
® No — Skip Attachment F.
If answered Yes above, does the hydraulic capacity in Section III, Item 4 exceed 80%?
❑ Yes (the hydraulic capacity is greater than 80%) — Pursuant to I5A NCAC 02T .0118(2), prior to exceeding 90 percent of the
system's permitted hydraulic capacity (based on the average flow during the last calendar year), the permittee shall obtain all
permits needed for the expansion of the wastewater treatment, utilization, or disposal system and, if construction is needed,
submit final plans and specifications for expansion, including a construction schedule. If expansion is not proposed or is proposed
for a later date, a justification shall be made that wastewater treatment needs will be met based on past growth records and future
growth projections, and as appropriate, shall include conservation plans or other specific measures to achieve waste flow
reductions.
® No — Skip Attachment F.
ATTACHMENT G — EASEMENT, ENCROACHMENT, AND LEASE AGREEMENTS
Does the Permittee own all of the land associated with the wastewater collection, treatment, conveyance, and utilization system?
® Yes — Skip Attachment G.
❑ No — Pursuant to 15A NCAC 02T .0116(c), provide a copy of all easements, lease agreements, and encroachment agreements
allowing the Permittee to operate and maintain the wastewater collection, treatment, conveyance, and utilization system on
property not owned by the Permittee.
ATTACHMENT H — AFFILIATIONS
Are the Permittee's affiliations of record correct? Check affiliations.
❑ Yes — Skip Attachment H.
® No — Provide the corrected affiliations and their contact information.
ATTACHMENT I — COMPLIANCE SCHEDULES
Does the existing permit include any Compliance Schedules? (See Section I of the most recently issued permit)
❑ Yes — Submit documentation that the compliance schedules have been met.
® No — Skip Attachment I.
ATTACHMENT J — CIVIL PENALTIES AND OUTSTANDING VIOLATIONS
Does the Permittee have any existing civil penalties or outstanding violations?
❑ Yes (civil penalties) — Submit payment for the civil penalty, or proof of remission request.
❑ Yes (violations) — Submit a copy of your response to the Notice of Violation.
® No — Skip Attachment J.
FORM: RWS-R 02-21 Page 5 of 6

ATTACHMENT K — INDUSTRIAL WASTEWATER
Does the wastewater composition in Section III, Item 5 include any industrial wastewater?
® Yes — Proceed to the next question.
❑ No — Skip Attachment K.
Has the nature of the industrial wastewater changed since the last permit issuance (i.e., changes in industrial process, introduction of
new materials or chemicals, etc.)?
❑ Yes — Provide a chemical analysis of the wastewater pursuant to the requirements in 15A NCAC 02U .0201(g). Provide an
overview of the manufacturing process; an inventory of all chemical and biological materials used in the manufacturing process;
and an overview of the cleaning and treatment methodology.
® No — Provide an overview of the manufacturing process; an inventory of all chemical and biological materials used in the
manufacturing process; and an overview of the cleaning and treatment methodology.
ATTACHMENT L — SETBACK WAIVERS
Does the existing permit include setback waivers?
❑ Yes — Pursuant to 15A NCAC 02T .0701(g), provide setbacks waivers that have been written, notarized, signed by all parties
involved, and recorded with the county Register of Deeds. Waivers involving the compliance boundary shall be in accordance
with 15A NCAC 02L .0107.
No — Skip Attachment L.
APPLICANT'S CERTIFICATION
attest that this application
(Signature authority's name as noted in Section I, Item 3)
has been reviewed by me and is accurate and complete to the best of my knowledge. I understand that if all required parts of this
application package are not completed, and that if all required supporting information and attachments are not included, this
application package will be returned as incomplete. I further certify pursuant to 15A NCAC 02T .0120(b), that the applicant, or any
parent, subsidiary, or other affiliate of the applicant has: not been convicted of environmental crimes under; not previously abandoned
a wastewater treatment facility without properly closing the facility; not paid a civil penalty; not been compliant with any compliance
schedule in a permit, settlement agreement, or order; not paid an annual fee.
Note: The Applicant's Certification shall be signed pursuant to 15A NCAC 02T .0106(b). An alternate person may be delegated as
the signing official if a letter is provided pursuant to I5A NCAC 02T .0106(c). Pursuant to § 143-215.6A and § 143-2I5.6B, any
person who knowingly makes any false statement, representation, or certification in any application package shall be guilty ofa Class
2 misdemeanor, which may include a fine not to exceed $10,000 as well as civil penalties up tooe$y25,000 per violation.
Signature: f Date: . / "-T;1.N �Z—
THE COMPLETED APPLICATION AND ATTACHMENTS SHALL BE SUBMITTED AS A SINGLE PDF FILE VIA:
Email:
Non-Discharge.Reoortsriencdenr.eov
Laserfiche Upload:
httos://edocs.deq.ne.gov✓FormslNonDischarge-Branch-
Submittal-Form-Ver2
FORM: RWS-R 02-21
Page 6 of 6

WAREHOUSE
EXPANSION
BUILDING -OS
FINISHED FLOOR
340.0.
WAREHOUSE
EXPANSION
FOR LINE 2
FLOOR 340.0'
For Reference Only
H
D
Se qirusTM
A CSL COMPANY
475 Green Oaks Parkway
Holly Springs, North Carolina
PROJECT:
REV DATE
REVISION DESCRIPTION
APPROVED BY/DATE
REV
DATE
REVISION DESCRIPTION
APPROVED BY/DATE
1
290CT12
ECO 355
BRUCE BUCKOSKI 290CT12
2
06JAN20
ECO 2020-002
N/A
3
12NOV21
ECO 2021-036
JEREMY HAMMONS
THIS DOCUMENT CONTAINS PROPRIETARY
INFORMATION OF SEQIRUS AND IS TENDERED SUBJECT
TO THE CONDITIONS THAT THE INSTRUMENTS, DEVICES
AND SYSTEMS REPRESENTED THEREBY AND ALL
INFORMATION RELATING THERETO (A) BE RETAINED IN
CONFIDENCE; (B) NOT BE REPRODUCED OR COPIED
IN WHOLE OR IN PART; AND (C) NOT BE USED OR
INCORPORATED IN ANY PRODUCT EXCEPT UNDER
EXPRESS WRITTEN AGREEMENT WITH SEQIRUS.
TITLE:
CIVIL
OVERALL
TOPOGRAPHY PLAN
A
SCALE
DRAWING NUMBER
REV
8
7
6
5
4
3
NONE
2
00-C-25-90-01
3
1
CADD FILE No. 00C259001.DWG

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VIRAL PILOT PLANT
BUILDING-09
FINISHED FLOOR 340.0'
OAP T X OH ..
- 7
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BUILDING-01
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FILL FINISH
BUILDING-04
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FINISHED FLOOR 340.0'
WAREHOUSE
BUILDING-06
FINISHED FLOOR 340.0'
WAREHOUSE
EXPANSION
BUILDING-06
FINISHED FLOOR
340.0'
OUTLET PROTEC
CLASS 'B' RIP
16' x 18' x 2'
EST 19 TONS
EST 21 SY FF
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NOTES:
1. ALL CONSTRUCTION SHALL CONFORM TO TOWN OF HOLLY SPRINGS ENGINEERING
DESIGN AND CONSTRUCTION STANDARDS, UNLESS APPROVED BY TORS.
2. THE 100 YEAR FLOOD PLAIN, ZONE AE, IS SHOWN ON DWG. 00-C-35-99-02.
NO CONSTRUCTION IS PLANNED IN THIS FLOOD PLAIN AREA (FIRM PANEL 0628,
FIRM PANEL 0649). NO CONSTRUCTION OCCURS IN, OR BELOW, FLOOD PLAIN.
3. AREA IS WAKE COUNTY GIS PIN #0639-92-8228 AND IS IN 'CAPE FEAR' RIVER
BASIN.
3. MONUMENTS
MONUMENT
ELEVATION
EAST
M1A
11820.2517
M2A
11826.4036
M3
13133.1697
M4
12805.9276
ESTABLISHED PER BASS, NIXON, AND KENNEDY SURVEY:
STATE PLANE
NORTH
692150.2898
351.33
691627.9702
331.74
693027.0490
362.40
693197.7828
339.95
COORDINATE
EAST
2038913.0092
2039224.6698
2039921.5993
2039443.2474
PLANT COORDINATE
NORTH
5992.0167
5383.8126
6241.4242
6629.8545
MONUMENTS HAVE BEEN TIED TO TOWN OF HOLLY SPRINGS "WELCOME" MONUMENT
F
YD
RW
UGP
OHP
Of
PROPERTY OWNER:
PROPERTY AREA:
SANITARY SEWER
STORM SEWER
CITY WATER MAIN
STORM YARD DRAIN
STORM UNDERDRAIN
RECLAIMED WATER MAIN
UNDERGROUND POWER
OVERHEAD POWER
OVERHEAD POWER -TEMP
TELECOMMUNICATIONS LINE
FIRE PROTECTION LINE
GAS LINE
NOVARTIS VACCINES & DIAGNOSTICS
190 ROSEWOOD CENTRE DR. SUITE 100
HOLLY SPRINGS, NC 27540
TRACT #1 85.0 ACRES
TRACT #2 77.0 ACRES
TRACT #3 5.0 ACRES
TRACT #4 15.0 ACRES
TOTAL ACRES 182.0 ACRES
ZONING DESIGNATION: HSBP-PUD
DISTRICT: MANUFACTURING
KEY PLAN
For Reference Only
SegirusTM
A CSL COMPANY
475 Green Oaks Parkway
Holly Springs, North Carolina
PROJECT:
REV DATE
REVISION DESCRIPTION
APPROVED BY/DATE
REV
DATE
REVISION DESCRIPTION
APPROVED BY/DATE
0
20SEP12
RECORD FROM VPP PROJECT CONSTRUCTION
JERRY ANDERSON 20SEP12
17APR17
ECO 657
N/A
2
21JAN19
ECO 802; CC1026970
N/A
3
12NOV21
ECO 2021-036
JEREMY HAMMONS
THIS DOCUMENT CONTAINS PROPRIETARY
INFORMATION OF SEQIRUS AND IS TENDERED SUBJECT
TO THE CONDITIONS THAT THE INSTRUMENTS, DEVICES
AND SYSTEMS REPRESENTED THEREBY AND ALL
INFORMATION RELATING THERETO (A) BE RETAINED IN
CONFIDENCE; (B) NOT BE REPRODUCED OR COPIED
IN WHOLE OR IN PART; AND (C) NOT BE USED OR
INCORPORATED IN ANY PRODUCT EXCEPT UNDER
EXPRESS WRITTEN AGREEMENT WITH SEQIRUS.
TITLE:
CIVIL
OVERALL
SITE UTILITIES
SCALE
DRAWING NUMBER
REV
8
7
6
5
4
3
NONE
2
00-C-35-90-01
3
1
CADD FILE No. 00C359001.DWG

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BUILDING-07
FINISHED FLOOR 340.0
pH NEUTRAL'i�ATI
BUILDING-11A
ELECTRICAL
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,;; �RVICES
BUILDING-16
„..1 FF 340.0'
X X X �X
VIRAL PILOT PLANT
BUILDING-09
FINISHED FLOOR 340.0'
7
5
QC LABS
BUILDING-01
FINISHED FLOOR 340.0'
FILL FINISH
BUILDING-04
FINISHED FLOOR 340.0
WAREHOUSE
BUILDING-06
FINISHED FLOOR 340.0'
WAREHOUSE
EXPANSION
BUILDING-06
FINISHED FLOOR
340.0'
X
4
v
3
00
m
LOUTLET PROTEC
CLASS 'B' RIP R
16' x 18' x 2'
EST 19 TONS
EST 21 SY FF
/
/
/
/
7,'27
LA
LA '73
*O.
THOMAS M/« ROAD
\
\
THIS DOCUMENT CONTAINS PROPRIETARY
INFORMATION OF SEQIRUS AND IS TENDERED SUBJECT
TO THE CONDITIONS THAT THE INSTRUMENTS, DEVICES
AND SYSTEMS REPRESENTED THEREBY AND ALL
INFORMATION RELATING THERETO (A) BE RETAINED IN
CONFIDENCE; (B) NOT BE REPRODUCED OR COPIED
IN WHOLE OR IN PART; AND (C) NOT BE USED OR
INCORPORATED IN ANY PRODUCT EXCEPT UNDER
EXPRESS WRITTEN AGREEMENT WITH SEQIRUS.
SCALE
NONE
2
NOTES:
1. ALL CONSTRUCTION SHALL CONFORM TO TOWN OF HOLLY SPRINGS ENGINEERING
DESIGN AND CONSTRUCTION STANDARDS, UNLESS APPROVED BY TORS.
2. THE 100 YEAR FLOOD PLAIN, ZONE AE, IS SHOWN ON DWG. 00-C-35-99-02.
NO CONSTRUCTION IS PLANNED IN THIS FLOOD PLAIN AREA (FIRM PANEL 0628,
FIRM PANEL 0649). NO CONSTRUCTION OCCURS IN, OR BELOW, FLOOD PLAIN.
3. AREA IS WAKE COUNTY GIS PIN #0639-92-8228 AND IS IN 'CAPE FEAR' RIVER
BASIN.
3. MONUMENTS ESTABLISHED PER BASS, NIXON, AND KENNEDY SURVEY:
MONUMENT STATE PLANE COORDINATE
ELEVATION
NORTH
EAST
M1A 692150.2898
11820.2517 351.33
M2A 691627.9702
11826.4036 331.74
M3 693027.0490
13133.1697 362.40
M4 693197.7828
12805.9276 339.95
EAST
2038913.0092
2039224.6698
2039921.5993
2039443.2474
PLANT COORDINATE
NORTH
5992.0167
5383.8126
6241.4242
6629.8545
MONUMENTS HAVE BEEN TIED TO TOWN OF HOLLY SPRINGS "WELCOME" MONUMENT
PROPERTY OWNER:
PROPERTY AREA:
STORM SEWER
NOVARTIS VACCINES & DIAGNOSTICS
190 ROSEWOOD CENTRE DR. SUITE 100
HOLLY SPRINGS, NC 27540
TRACT #1 85.0 ACRES
TRACT #2 77.0 ACRES
TRACT #3 5.0 ACRES
TRACT #4 15.0 ACRES
TOTAL ACRES 182.0 ACRES
ZONING DESIGNATION: HSBP-PUD
DISTRICT: MANUFACTURING
For Reference Only
seqlrusT
A CSL COMPANY
PROJECT:
TITLE:
475 Green Oaks Parkway
Holly Springs, North Carolina
CIVIL
OVERALL
SITE UTILITIES
STORM SEWER
DRAWING NUMBER
00-C-35-90-01 -ST
1
CADD FILE No. 00C359001 ST.DWG
REV
0
H
D
A

Attachment H — Affiliations of Record
Segirus, Inc.
475 Green Oaks Parkway
Holly Springs, NC 27540
Reclaimed Water Permit #: WQ0034603
Legally Responsible for Permit
David Sehgal, VP of Manufacturing and Site Head
Persons with Permitting Signature Authority
T e
yp
Contact
Name
Title
Address
Phone
Email
Permit
Robert
Rezek
Director of
EHS
475 Green Oaks
Parkway, Holly
Springs, NC
919-455-0359
[e-mail]
Permit
Comora
Jarrett
Senior
EHS
Specialist
Same as above
919-897-3290
[e-mail]
Permit
Anne
Marie
Baese
EHS
Specialist
Same as above
919-324-4910
[e-mail]
Permit Contact Person: Anne Marie Baese

gailrus.
A CSL Company
Date: January 24, 2022
Division of Water Resources
Non -Discharge Permitting Unit
1617 Mail Service Center
Raleigh, NC 27699-1617
Subject: Permitting Signature Authority
Seqirus
Environmental, Health & Safety
475 Green Oaks Parkway
Holly Springs, NC 27540
To Whom It May Concern:
As an appropriate signing official for Seqirus, Inc as designated by 15A NCAC 2H .0206, I
hereby delegate authority to sign and certify all permit applications, reports or other permit -
related documents to the following staff for the following permit types (sewer, spray, land
application) and/or permit numbers:
Position
Director of Environmental,
Health and Safety
Specialist: Environmental
Health and Safety
Senior Specialist:
Environmental Health and
Safety
Person Currently in
Position
Permit Type or Permit
Number
Robert Rezek
Anne Marie Baese
Comora Jarrett
W00034603
W00034603
WQ0034603
If you have any questions, please contact me at the following:
Permittee/Applicant name: Dave Sehgal
Title: Vice President of Manufacturing and Site Head
Complete mailing address: 475 Green Oaks Parkway
City: Holly Springs State: NC Zip: 27540
Telephone number: 919-577-5850 Facsimile number: Upon Request
Sincerely,
Z (D G Y1 Zc';I2-/
Dave Sehgal
Vice President of Manufacturing and Site Head

Attachment K
Manufacturing Process Overview
Seqirus Holly Springs is a biopharmaceutical manufacturing facility that runs 24/7
operations, with approximately 700 Seqirus employees and approximately 200 contract
workers onsite to produce end -to -end flu cell culture. It is an automated, state of the art
manufacturing and laboratory space with a pilot plant and small-scale form/fill facilities
and technical development laboratories. The facility allows for multi -product formulation,
filling, inspection and packaging. In addition to flu vaccine production, this facility also
produces a product called MF59, which is a flu vaccine adjuvant. The facility also
contains quality control laboratories to allow for full test and release of product.
The Holly Springs site is a US Strategic Pandemic Preparedness and Response Site
built in partnership with the US Department of Health and Human Services (HHS). The
purpose of this is to establish domestic cell -based manufacturing that is deliverable in
the form of two pre -pandemic lots per year.

Seqirus, Inc. Holly Springs Chemical Inventory
eBinder Product List Location: (All Locations}
Product Name Manufacturer CAS #
VI 16832 1430218-51-1
SB 203580 (hydrochloride) 869185-85-3
Purvalanol B 212844-54-7
PP58 212391-58-7
PKR-IN-C16 608512-97-6
NIK SMII 1660114-31-7
LY-364947 396129-53-6
Lapatinib 231277-92-2
Dasatinib 302962-49-8
CBL0137 hydrochloride 1197397-89-9
BX795 702675-74-9
Bisindolylmaleimide X (hydrochloride)
Sodium thioglycolate Sigma Chemical Company
BAY-985 MedChemExpress USA
Pierce lodoacetamide, No -Weigh Format Life Technologies Corporation 144-48-9
Sodium chloride Ph.Eur./USP/BP/JP/ENDOTOXIN TESTED VWR International, LLC
TBS, Sample Diluent Buffer, STAB-ELISA-r Enzyme Conjugate Stabilizer for use with HRP, 500mL, STAB-ELISA-r Enzyme Conjugate
Stabilizer for use with HRP, IL, Conjugate Diluent/HRP, Mix-l-Go Sample Diluent, 25mL, Mix-N-Go Sample Diluent, 100mL Cygnus Technologies, LLC
lodoacetamide Sigma Chemical Company 144-48-9
Hydrazine sulfate salt Sigma -Aldrich Corporation
Hexamethylenediamine ALDRICH CHEMICAL COMPANY
Multipurpose R&O Phillips 66 Lubricants
NEOVAC SA-H Moresco Corporation
Orion 910001, 910060 & 9100CB pH Electrode Storage Solution Thermo Fisher Scientific
PBS, PH 7.4 Life Technologies Corporation
Penicillin -Streptomycin -Neomycin (PSN)Antibiotic Mixture Life Technologies Corporation
Phenolphthalein Indicator Powder HACH LANGE GmbH
Phosphate -Buffered Saline (PBS) 7.2 (10X) liquid Life Technologies Corporation
Phosphate -Buffered Saline (PBS) 7.4 (1X) liquid Life Technologies Corporation
Potassium Chloride, EP, BP, DAB, PhFR, USP, FCC EMD Millipore Corp. 7447-40-7
Potassium dihydrgen phosphate anhydrous 99.995 Suprapur EMD Millipore Corporation 7778-77-0
Potassium Hydroxide Pellets GR ACS EMD Millipore Corporation 1310-58-3
Potassium Phosphate, Monobasic [Potassium Dihydrogen Phosphate] GR ACS EMD Millipore Corporation 7778-77-0
ProKlenz TWO Stens Corporation
PVC Electrical Conduit Cement 633L Low VOC The RectorSeal Corporation
R-410A National Refrigerants, Inc.
ROSS Reference Electrode Filling Solution 810007 Thermo Scientific
SCRUBS Graffiti and Paint Remover Towels ITW Professional Brands
SELtect450 Southeastern Laboratories, Inc.
Sheep Serum Sigma Chemical Company
SILVER NITRATE, VOLUMETRIC SOLUTIONS (0.24 - 4.8%) Avantor Performance Materials, Inc. 7761-88-8
SILVERQUEST: DESTAINER A Life Technologies Corporation
SILVERQUEST: DESTAINER B Life Technologies Corporation
SmokeCheck, Smoke Detector Tester, Model No. 25 S, 2.5 oz. Chicago Aerosol, LLC
SODIUM ARSEN ITE ANHYDROUS Avantor Performance Materials 7784-46-5
Sodium Bicarbonate Avantor Performance Materials, Inc.
Sodium bitarfrate monohydrate 98% Pfaltz & Bauer, Inc.
Sodium Bromide EMD Millipore Corp. 7647-15-6
SODIUM CARBONATE ANHYDROUS Mallinckrodt Baker, Inc. 497-19-8
SODIUM CHLORIDE Avantor Performance Materials, Inc. 7647-14-5
Sodium Hydroxide, Solution, 0.1 -2.0 N Avantor Performance Materials, Inc.
Sodium Hypochlonte 6% Hawkins, Inc. 7681-52-9
Sodium Phosphate Monobasic, Monohydrate Avantor Performance Materials, Inc. 10049-21-5
Sodium Standard ULTRA SCIENTIFIC
Stabilized Gram Iodine BD DIAGNOSTIC SYSTEMS
STARCH SOLUBLE Avantor Performance Materials, Inc. 9005-84-9
Starch -Acid Indicator Powder LaMotte Company, Inc. 5329-14-6
Sulfuric acid 96% Suprapur EMD Millipore Corporation 7664-93-9
SWNW0013 CONTEC, INC. 67-63-0
Taqman Universal PCR Master Mix Life Technologies Corporation
Tetramethylammonium Hydroxide (10% in Water) TCI AMERICA 75-59-2
Vanillin Melting Point Standard U. S. Pharmacopeia 121-33-5
WB BLOCKER DILUENT B ALIQ Life Technologies Corporation
WELLER WB1 2oz.- BUTANE FUEL Cooper Tool Co./Weller
Wescodyne Disinfectant Stens Corporation
Xylenol Orange tetrasodium salt ALFA AESAR
Zoom Spout Oiler LA -CO INDUSTRIES, INC.
ZWITTERGENT 3-14 Detergent EMD Chemicals Inc.
5367 Henkel Loctite Adhesives Ltd
Antibodies & Positive Controls - EXEMPT LETTER nanoTools Antikorpertechnik GmbH & Co. KG
CELLUFINE SULFATE JNC Corporation
di -Sodium hydrogen phosphate dehydrate suitable for use as excipient EMPROVE exp Ph Eur,BP,USP MERCK KGaA
Glucose monohydrate CRS - EXEMPT LETTER EDQM European Directorate for the Quality of Medicines & HealthCare
LACTOSE (ANHYDROUS) CRS - EXEMPT LETTER EDQM European Directorate for the Quality of Medicines & HealthCare
L-Glutamine 200mM 500 ml - EXEMPT LETTER Lonza
ProKlenz TWO Acid Process and Research Cleaner Stens Corporation
R2A Agar- LI EP 30m1- EXEMPT LETTER EMD Millipore Corporation
SeaKem ME Agarose Lonza Ltd.
B-Propiolactone Ferak Benin GmbH
10% ADCF Antifoam Solution, 8X0.5L Cytiva Austria
2,5-bis((9Z,12Z)octadeca-9,12-den-l-yloxy)benzyl 4-(dimethylamino)butanoate WUXI APPTEC (Tianjin) Co., Ltd.
Acetic anhydride SIGALD
Acetone EMD Chemicals Inc. 67-64-1
Antifoam A Southeastern Laboratories, Inc.
Anti -Mouse IgG (whole molecule)—Peroxidase, antibody produced in rabbit Sigma Chemical Company
Bel -Ray Molylube 126 EP Grease 2 Bel -Ray Company, Inc.
Benzonase endonuclease EMPROVE EXPERT EMD Millipore Corporation
BufferJ, Novartis HyClone Laboratories, Inc.
Buffer M (PBS, pH 7.2) Novartis Vaccines & Diagnostics, Inc.
Capto Core 700, 5 L Cytiva
Carbon Dioxide (0.0001% - 2.999%) in Nitrogen Aigas USA, LLC 7727-37-9

Caustic Soda 50%, FCC, SPCL Hawkins, Inc.
CETYL TRIMETHYL AMMONIUM BROMIDE A&C AMERICAN CHEMICALS LTD. 57-09-0
Citric Acid 50% SPCL Hawkins, Inc.
Citric Acid, 50% Hawkins, Inc.
CitriSurf 77 Stellar Solutions Inc
Conductivity Standard, 10,000 pS/cm (10 mS/cm) at 25"C 5400 ppm TDS as NaCI Ricca Chemical Company 7647-14-5
DECON-AHOL 99% Veltek Associates, Inc. 67-63-0
DECON-AHOL Steele WFI Formula Aerosol Veltek Associates, Inc.
DECON-AHOL WFI Aerosol Veltek Associates, Inc.
DECONLIean Sterile Veltek Associates, Inc.
Destain II Teknova Inc
DM133P1C Base Powder w/o L-Glutamine & Glutamate FUJIFILM Irvine Scientific, Inc.
EATON GREY RAABE COMPANY
Hydrochloric acid fuming 37% EMPROVE ESSENTIAL Ph Eur,BP,JP,NF EMD Millipore Corporation
Hydrochloric Acid, 0.02N AquaPhoenix Scientific 7647-01-0
ICWB LSPR 12PK FLUOR GREEN MARKING Rust-Oleum Corp.
Interflon Fluor Grease 2 Interflon b.v.
ISE Buffer Diamond Diagnostics
KolliphorP 188 BASF CORPORATION
KOLORSAFE LIQUID ACID NEUTRALIZER NPS Corporation
KOLORSAFE LIQUID BASE NEUTRALIZER NPS Corporation
L-Cystine Sigma Chemical Company
LENOX ROSIN CORE LEAD FREE SOLDER LENOX
LMI Buffer A; Novartis HyClone Laboratories, Inc.
Magnesium chloride hexahydrate ALFA AESAR 7791-18-6
Magnesium chloride hexahydrate cryst. EMPROVE ESSENTIAL Ph Eur,BP,USP,JPC,FCC,E 511 EMD Millipore Corporation 7791-18-6
MDCK PFM MEDIA AGT Life Technologies Corporation
MDCK PFM Media AGT INVITROGEN CORPORATION
NICKEL -CADMIUM SEALED CELL BATTERY SAFT AMERICA INC.
No-Tox HD Food Grade Grease 0 Bel -Ray Company, LLC
NPE Cleaning Solution Clinical Diagnostic Solutions Inc
Oxalic acid dehydrate Fisher Scientific 6153-56-6
Phosphate -Buffered Saline (PBS) 1X KD Medical Inc
Phosphoric Acid 85% NF/EP Hawkins, Inc. 7664-38-2
Polyoxyetirylene (80) Sorbitan Monooleate EMD Chemicals Inc. 9005-65-6
Polysorbate 80, Polysorbatum 80 Fagron UK Ltd
Potassium dihydrogen phosphate cryst., EMPROVE ESSENTIAL Ph Eur,BP,JPC,NF,E 340 EMD Millipore Corporation 7778-77-0
Potassium Iodide Iodate, 0.0158N AquaPhoenix Scientific
Propane Airgas USA, LLC 74-98-6
Rabbit Anti -Avian Influenza (H5N 1) Neuraminidase Antibody PROSCI INCORPORATED
RAID CONCENTRATED DEEP REACH FOGGER S.C. Johnson & Son, Inc.
Rebel Diluent, SMA 908 Devices Inc.
RESINA SODER-WICK, RESINA SODER-WICK SD, RESINA SODER-WICK SNIT, REINA SODER-WICK BGA - SPANISH CHEMTRONICS
Sodium Chloride (USP/EP) Cytiva Austria 7647-14-5
SODIUM CHLORIDE MULTI-COMPENDIAL A&C AMERICAN CHEMICALS LTD. 7647-14-5
Sodium Chloride Solution HyClone Laboratories, Inc. 7647-14-5
Sodium Chloride USP/EP (NaCI) Cytiva Austria 7647-14-5
Sodium Hydroxide Cytiva Austria 1310-73-2
Sodium hydroxide Vetec
Sodium Hydroxide 50% FCC SPCL Hawkins, Inc.
Sodium Hydroxide Solution (>/= 1, <2%) Mixture HyClone Laboratories, Inc.
SODIUM PHOSPHATE MONOBASIC MONOHYDRATE MULTI-COMPENDIAL A&C AMERICAN CHEMICALS LTD. 10049-21-5
Squalene Sigma -Aldrich Corporation
Squalene, Redistilled Sigma Chemical Company
STERI-PEROX 6% WIPE Veltek Associates, Inc.
SUPER GLUE GEL Pacer Technology
TOALLITAS H MEDAS DE LIMPIEZA DE LENTES DE LA MARCA SIGHT SAVERS - SPANISH Bausch & Lomb Incorporated
TRIS, 0.5M buffer solution, pH 8.6 ALFA AESAR 77-86-1
TRYPTIC SOY BROTH Teknova Inc
TSB for TSB Hold Studies Cytiva Austria
Waterproof Grease Bel -Ray Company, LLC
YSI2357 Buffer Concentrate Kit YSI, Inc.
10% ADCF Antifoam Solution, 0.5L Cytiva Austria
2-PROPANOL Life Technologies Corporation 67-63-0
AccuGENE 10% SDS Lonza Ltd.
Albumin Standard Thermo Fisher Scientific, Pierce Biotechnology
Ammonium carbonate ALFA AESAR 506-87-6
Ammonium thiocyanate ALFA AESAR 1762-95-0
ARGININE HYDROCHLORIDE CRS EDQM European Directorate for the Quality of Medicines & HealthCare
BD Cytofx/Cytoperm Fixation and Permeabilization Solution BD Biosciences, Pharmingen
BD Perm/Wash Penn/Wash Buffer BD Biosciences, Pharmingen
Buffer pH 4.0 Red EMD Millipore Corporation
BUFFER Q A&C AMERICAN CHEMICALS LTD.
Capto Core 700, 60 L Cytiva
Cholera filtrate Sigma Chemical Company
CitriSurf 77 Plus Stellar Solutions Inc
Cleaning Solution Sartodus Stedim Biotech GmbH
Conductivity Standard, 100,000 pS/cm (100 mS/cm)at25"C 65,750 ppm TDS as NCI Ricca Chemical Company 7647-14-5
SELtroI 102 Southeastern Laboratories, Inc.
Coomassie Stain Kit - KIT Bio-Rad Laboratories, Life Science Group
DECON-CLEAN Veltek Associates, Inc.
DECON-CLEAN WFI FORMULA AEROSOL Veltek Associates, Inc.
Dibasic Sodium Phosphate Dehydrate (USP/EP), Packaged for Novartis HyClone Laboratories, Inc. 10028-24-7
Dimethyl Sulfoxide Honeywell International, Inc. 67-68-5
di -Sodium hydrogen phosphate dehydrate EMPROVE ESSENTIAL Ph Eur,BP,USP EMD Millipore Corporation
Electrolyte Friscolyt Mettler Toledo GmbH
FEHLING SOLUTION A, USP TEST SOLUTION Spectrum Chemical Manufacturing Corporation 7758-99-8
FlashGel Cassette Lonza Ltd.
Fluid Thioglycollate Media Millipore Corporation
GelBond Film Lonza Ltd.
Halocarbon R-410A Airgas USA, LLC
HYDROCHLORIC ACID 30% / BULK Brenntag Nordic AB
Hydrogen peroxide 35% MERCK KGaA
Iodine monobromide ALFA AESAR 7789-33-5
Iron Solution for DM122P/DM133P IRVINE SCIENTIFIC
L-Glutamic acid Sigma Chemical Company
L-Tyrosine EMPROVE EXPERT Ph Eur,JP,USP EMD Millipore Corporation
MDCK PFM MEDIA AGT Life Technologies

Mercaptoacetic acid ALFA AESAR 68-11-1
MOBILUX EP 2 East Coast Lubes Ply Ltd
MPLC Total Nucleic Acid Isolation Kit Roche Diagnostics Deutschland GmbH
Mycoplasma Discriminatory Pos Cont Life Technologies Corporation
Tnchloroacetic acid Sigma -Aldrich Corporation 76-03-9
DECON-AHOL Aerosol Veltek Associates, Inc.
Sodium acetate Sigma -Aldrich Corporation 127-09-3
Tnfluoroacetic acid ALFA AESAR 76-05-1
Tnfluoroacetic acid Sigma -Aldrich Corporation 76-05-1
Box, PrepSEQ Lysis buffer Life Technologies Corporation
Hydrochloric Acid, 1.00 Normal Ricca Chemical Company
Nitric acid SIGALD 7697-37-2
Genetron 410A Honeywell International, Inc.
Heptane SIGALD
Cryocool Heat Transfer Fluid Thermo Fisher Scientific (Asheville), LLC
Mechanical Pump Oil- Ultragrade 15, 19, 20, 70 Edwards 8042-47-5
DEC-AHOL WFI FORMULA Veltek Associates, Inc.
Flu -Cell -Culture -Vaccine Seqirus
L-Glutamic acid AJINOMOTO CO., INC.
QNZ MedChemExpress USA 545380-34-5
Methylene Blue Fisher Scientific International 7220-79-3
Conductivity Neutralizing Solution AquaPhoenix Scientific, Inc.
Conductivity Standard, 10 pS/cm at 25"C (4.7 ppm TDS as NaCI) Ricca Chemical Company 7647-14-5
Fluad Seqims
MF-59 Adjuvant Seqims
Myristyltrimethylammonium bromide Sigma Chemical Company 1119-97-7
DECON-SPORE 200 Plus Veltek Associates, Inc.
Ethanolamine Sigma -Aldrich Corporation
Phenolphthalein Sigma -Aldrich Corporation 77-09-8
Thimerosal Sigma Chemical Company 54-64-8
10X TURBO DN ase Buffer Thermo Fisher Scientific Baltics UAB
Benzoic acid Sigma -Aldrich Corporation 65-85-0
Bmker Standard solvent, for MALDI MS, 50% ACN + 47.5% H2O + 2.5% TFA Sigma -Aldrich Corporation 75-05-8
Conductivity Standard, 20,000 pS/cm (20 mS/cm) at 25"C (11,000 ppm TDS as NaCI) Ricca Chemical Company 7647-14-5
DPD Total Chlorine Reagent Hach Company
Glutaraldehyde solution Sigma -Aldrich Corporation
HYPO-CHLOR 0.52% Veltek Associates, Inc.
Kinetic- QCL Bulk Kit 2400 Test Kit- KIT Lonza Ltd.
Manganese(II) sulfate monohydrate ALFA AESAR 10034-96-5
MolyVer 1 Molybdenum Reagent Hach Company
Nitrogen Airgas USA, LLC 7727-37-9
Proteinase K QIAGEN GmbH
RapiGest SF, 1 mg , 5/pk ERA a Waters Company 308818-13-5
Sodium azide Sigma -Aldrich Corporation 26628-22-8
Vi-CELL Quad and Single Pak - KIT Beckman Coulter, Inc.
Water LAL Reagent Lonza Ltd.
Sodium chloride EMPROVE EXPERT Ph Eur,BP,ChP,JP,USP EMD Millipore Corporation
SulfaVer4 Sulfate Reagent Hach Company
Glycerol SIGALD 56-81-5
Tromethamine Avantor Performance Materials, LLC.
SeaKem LE Agarose Lonza Ltd.
Triton X-100 Sigma Chemical Company 9002-93-1
WD-40 Multiuse Product Aerosol WD-40 Company
Buffer Solution Hardness 1 pH 10.1 ± 0.1 Hach Company
Cetyltrimethylammonium Bromide, Molecular Biology Grade EMD Millipore Corporation 57-09-0
Folin & Ciocalteu's phenol reagent Sigma -Aldrich Corporation
Potassium bromate ALFA AESAR 7758-01-2
Sodium Hydroxide Standard Solution 1.00 N Hach Company 1310-73-2
Vi-Cell Concentration Control Beckman Coulter, Inc.
Free Chlorine Indicator Solution for CL-17 Analyzer Hach Company
Klubersynth UH 1 6-060 Kliber Lubrication North America L.P.
NuPAGE Antioxidant Life Technologies Corporation
Phenol Red Sigma -Aldrich Corporation 143-74-8
L-Arginine monohydrochloride Sigma -Aldrich Corporation 1119-34-2
ROSS Reference Electrode Filling Solution Thermo Fisher Scientific
Buffer Solution pH 7.00 Yellow LabChem, Inc.
Acetylene Airgas USA, LLC 74-86-2
DNA Extractor Kit FUJIFILM Wako Pure Chemical Corporation
Freon 134a (HFC-134a) Refrigerant - Propellant Chemours Netherlands B.V. 811-97-2
l-Butanol SIGALD 71-36-3
Sodium sulfate anhydrous for analysis EMSURE ACS,ISO,Reag. Ph Eur EMD Millipore Corporation 7757-82-6
Tetrahydrofuran Sigma -Aldrich Corporation 109-99-9
Chloroform SIGALD 67-66-3
pH 10.01 Buffer Thermo Fisher Scientific
WD-40 Aerosol WD-40 Company
2,4-DINITROPHENYLHYDRAZINE Spectrum Chemical Manufacturing Corporation 119-26-6
Amberiite XAD4 Sigma Chemical Company 9003-694
Ammonium acetate ALFA AESAR 631-61-8
Ammonium molybdate (pars) tetrahydrate ALFA AESAR
Arsenic(III) oxide ALFA AESAR 1327-53-3
Benzoic acid ALFA AESAR 65-85-0
Caffeine Melting Point Standard U. S. Pharmacopeia 58-08-2
Calcium carbonate ALFA AESAR 471-34-1
Calcium carbonate SIGALD 471-34-1
Carbon Dioxide (3.00%- 80.5099%), Oxygen (0.0001 % - 19.4900%) in Nitrogen AIR LIQU IDE
Cesium chloride ALFA AESAR 7647-17-8
CIP 100 -Alkaline Process and Research Cleaner Steris Corporation
Citric Acid U. S. Pharmacopeia 77-92-9
Clorox Commercial Solutions Clorox Germicidal Bleach Clorox Professional Products Company
D-(+)-Glucose monohydrate ALFA AESAR 14431-43-7
Diethyl ether, anhydrous, ACS ALFA AESAR
Dimethyl sulfoxide Sigma Chemical Company
DNA AWAY MOLECULAR BIO-PRODUCTS, INC.
Crystal Violet Hydrate TCI AMERICA 548-62-9
CytoFLEX Sheath Fluid Beckman Coulter, Inc.
Drager-Tubes (which are classified as dangerous goods, PG III) Drager Safety AG & Co. KGaA
Ethanolamine ALDRICH CHEMICAL COMPANY 141-43-5
Ethidium bromide solution Sigma Chemical Company 1239-45-8

Ethyl alcohol, pure SIGALD 64-17-5
Freon 407C (R-407C) Refrigerant Chemours Netherlands B.V.
Gorilla Spray Adhesive The Gorilla Glue Company
Gram Crystal Violet BD DIAGNOSTIC SYSTEMS
Halocarbon 134a (1,1,1,2-Tetrafluoroethane) Airgas USA, LLC 811-97-2
Haynes CIP FILM Haynes ManufacWring Company
Herring Sperm DNA Promega Corporation
Hexane SIGALD 110-54-3
IMPERIAL 9520 PIPE SEALANT WITH PTFE 1.2 FL.OZ ITW Permatex
Isopropyl alcohol ALDRICH CHEMICAL COMPANY 67-63-0
Kolorsafe Liquid Acid Neutralizer NPS Corporation
Kolorsafe Liquid Base Neutralizer NPS Corporation
LB Broth (Miller) Sigma Chemical Company
Lead(II) acetate l hydrate, ACS ALFA AESAR 6080564
LightCycler480 RNA Master Hydrol.Probe Roche Diagnostics
LOCTITE 290 THREADLOCKER e WICKING GRADE Henkel Corporation
Methanol Avantor Performance Materials, LLC. 67-56-1
Methyl arachidate Sigma Chemical Company 1120-28-1
MPLC Total NA Isolation Kit -Large Volume Roche Diagnostics
Ninhydrin ALFA AESAR 485-47-2
Pierce BCA Protein Assay Reagent B, 25 mL Life Technologies Corporation
Polydimethylsiloxane U. S. Pharmacopeia 9016-00-6
Potassium bromide ALFA AESAR 7758-02-3
Protamines, sulfates ALFA AESAR 9009-65-8
Sequencing Grade Modified Trypsin, 100ug - KIT Promega Corporation
Sodium Bicarbonate Avantor Performance Materials, LLC.
Sodium hydrogen carbonate ALFA AESAR 144-55-8
Sodium hydroxide 1.0N VWR International 1310-73-2
Sodium nitrite ALFA AESAR
Sodium pentacyanonitrosylferrate(III) dehydrate ALFA AESAR
Sodium phosphate dibasic dihydrate Sigma Chemical Company
Sodium thiosulfate pentahydrate, ACS ALFA AESAR 10102-17-7
Solution 555 Rotor Cleaning Concentrate Beckman Coulter, Inc.
Diffusion Pump Oil Beckman Coulter, Inc.
Spernidine Sigma Chemical Company 124-20-9
Texwipe Wipers pre -wetted with 60% - 70 % IPA TexW ipe
Tns hydrochloride Sigma Chemical Company 1185-53-1
Trypsin rec. 3,5 MU per bottle Roche Diagnostics
Trypsin, 0.05% (1X) with EDTA 4Na, liquid Life Technologies Corporation
WB BLOCKER DILUENT A ALIQ Life Technologies Corporation
WHITE KNIGHT JET-LUBE, INC.
j-Propiolactone Sigma Chemical Company
20X TE Buffer Life Technologies Corporation
2-Propanol Sigma -Aldrich Corporation
2-TH IOBARBITU RIC ACID Avantor Performance Materials, LLC.
3M KCI Hach Company 7447-40-7
Acetic Acid, Glacial Avantor Performance Materials, Inc. 64-19-7
Ammonium bicarbonate Fluka Chemical Company 1066-33-7
AST-PPD Plumbers Pipe Dope ANTI -SEIZE TECHNOLOGY
AST -PUT Plumbers Putty ANTI -SEIZE TECHNOLOGY
Bovine Serum Albumin Sigma Chemical Company 9048-46-8
Broadley-James Electrolyte solution for Oxygen Sensors BROADLEY-JAMES CORP
CIP 100 Steris Corporation
CONTRAD 70 Beckman Coulter, Inc.
Coomassie Brilliant Blue R-250 ULTRA PURE VWR Chemicals, LLC 6104-59-2
COULTER CLENZ Beckman Coulter, Inc.
Dimethyl Sulfoxide U. S. Pharmacopeia 67-68-5
di -Sodium hydrogen phosphate dodecahydrate for analysis EMSURE ISO,Reag. Ph Eur EMD Millipore Corporation 10039324
DMEM Life Technologies Corporation
DOW CORNING HIGH VACUUM GREASE Dow Coming Corporation
Dust -Off The Original Compressed -Gas Duster Falcon Safety Products, Inc
Dynatex49635 Dielectric Grease DYNATEX, INC.
Formic Acid, 98% EMD Millipore Corp. 64-18-6
GOO GONE PRO -POWER SPRAY GEL MAGIC AMERICAN PRODUCTS, INC.
GORE Gasketing - EXEMPT LETTER W.L. Gore & Associates, Inc.
Gram Decolonzer BD DIAGNOSTIC SYSTEMS
Gram Safranin BD DIAGNOSTIC SYSTEMS
Hydrochloric Acid,ACS AquaPhoenix Scientific, Inc. 7647-01-0
HYDROGEN PEROXIDE Avantor Performance Materials, Inc. 7722-84-1
Hypo-Chlor Veltek Associates, Inc. 7681-52-9
Iron (II) ethylenediammonium sulfate ALFA AESAR
IsoFlow Sheath Fluid Beckman Coulter, Inc.
Koptec Ethanol, 200 Proof DLI
L-Cystine MP Biomedicals, LLC 56-89-3
Magnesium oxide ALFA AESAR
Mannitol Avantor Performance Materials, Inc.
MDCK PFM MEDIUM Life Technologies
MOBIL VACUOLINE 1405 Exxon Mobil Corporation
SILVERQUEST: STOPPER Life Technologies Corporation
N-alfa-4-Tosyl-L-arginine methyl ester hydrochloride Fisher Scientific 1784-03-8
No-Tox Food Grade Silicone Grease Bel -Ray Company, LLC
NPE Analyzer Cleaning Solution Clinical Diagnostic Solutions Inc
pH Calibration Solution (Low) Sartorius Stedim Biotech GmbH 877-24-7
pH Calibration Solution (Neutral) Sartorius Stedim Biotech GmbH
PNGase F (Glycerol Free) New England Biolabs
Quick Start Bradford Reagent, 1X Blo-Rad Laboratories, Life Science Group
R-2A Agar Sigma -Aldrich Corporation
Rebel BGE 908 Devices Inc.
Rinse Solution Sartonus Stedim Biotech GmbH
RNase Cocktail Enzyme Mix Thermo Fisher Scientific Baltics UAB
RNase T1 Thermo Fisher Scientific Baltics UAB
RoClean P111 Avesta Technologies Inc
RoClean P303 Avesta Technologies Inc
RQ1 RNase-Free DNase, 1,000u - KIT Promega Corporation
Sab. Dextr. Agar- ICR 30m1 EMD Millipore Corporation
SeaKem ME Agarose Capsugel Brasil Imp E Distnbuidora De Insumos Ftcos E Alimentos Ltda.
SeaKem ME Agarose Lonza Ltd.
SELcide 921 Southeastern Laboratories, Inc.

SELoxy678 Southeastern Laboratories, Inc.
SELquest2008 Southeastern Laboratories, Inc.
SELsperse 350 Southeastern Laboratories, Inc.
Silver diethyldithiocarbamate Sigma -Aldrich Corporation
Sodium Chloride (USP/EP), Packaged forNovartls HyClone Laboratories, Inc. 7647-14-5
Sodium Chloride 5M Quality Biological Inc
SODIUM HYDROXIDE 60% RAYON NSF PIONEER/OLIN/PPG MTL BRENNTAG MID -SOUTH, INC.
Sodium hydroxide Multi Compendia) Pellets Avantor Performance Materials Poland S.A.
Sodium metapenodate extra pure MERCK KGaA
SODIUM PHOSPHATE DIBASIC DIHYDRATE MULTI-COMPENDIAL A&C AMERICAN CHEMICALS LTD. 10028-24-7
Sorbitan tnoleate, Sorbitanii tnoleas Fagron UK Ltd
Squalene Supelco, Inc.
STERI-PEROX 6% WIPE Veltek Associates, Inc.
SULFURIC ACID 66 BE BRENNTAG MID -SOUTH, INC.
Tergazyme ALCONOX, INC.
Thimerosal, Ready Made Solution, 0.2 um filtered 100 mg/mL Sigma -Aldrich Corporation 54-64-8
TOYOPEARL-TSKgeI: group 21-1 TOSOH Corporation
Tween 80 (Polysorbate) suitable for use as excipient EMPROVE exp Ph Eur,JP,NF EMD Millipore Corporation
Urea Fisher Scientific 57-13-6
ZERO CALIBRATION Molecular Devices Corporation
0.5M EDTA, pH 8.0 1000 ML Thermo Fisher Scientific Baltics UAB
Arginine Hydrochloride U. S. Pharmacopeia 1119-34-2
Argon Airgas USA, LLC 7440-37-1
Conductivity standard 12.88 mS/cm Mettler Toledo GmbH 7447-40-7
Conductivity Standard, 5000 pS/cm at 25"C (2620 ppm TDS as NaCI) Ricca Chemical Company 7647-14-5
Coomassie Brilliant Blue R-250 Staining Solution Bio-Rad Laboratories, Life Science Group
DECON-QUAT 100 (Use Dilution) Veltek Associates, Inc.
DTT Thermo Fisher Scientific Baltics UAB
Endotoxin, E.coli O55:B5-KIT Lonza Ltd.
Fetuin, from fetal bovine serum Sigma Chemical Company 9014-81-7
Formaldehyde Solution 36% Histology Grade EMD Millipore Corporation
GDH Series Vacuum Pump Oil "Multi-Lube 100" Tnbologyfrech-Lube
Guanidine hydrochloride ALFA AESAR 50-01-1
Hexadecyltrimethylammonium bromide Sigma Chemical Company 57-09-0
HEXANE, UNISOLV Spectrum Chemical Manufacturing Corporation 110-54-3
Hydrochloric Acid GR ACS EMD Millipore Corporation
HYDROXY NAPHTHOL BLUE Fisher Scientific 165660-27-5
Lead(II) nitrate ALFA AESAR 10099-74-8
L-GLUTAMINE Ajinomoto do Brasil Industna e Comemio de Alimentos Ltda. 56-85-9
LOCTITE SF 7387 ACTIVATOR known as LOCTITE 7387 ACTIVATOR DEPEN Henkel Corporation
Magnesium chloride solution Sigma Chemical Company 7786-30-3
Magnesium chloride solution Sigma Chemical Company
Methyl Lignocerate TCI AMERICA 2442-09-1
Methyl Orange, ACS ALFA AESAR 547-58-0
Methyl Red TCI AMERICA 493-52-7
MOBIL DTE OIL HEAVY MEDIUM East Coast Lubes Pty Ltd
MOBILUX EP 2 Exxon Mobil Corporation
MODIFIED TE BUFFER 10/0.1 1000mL Life Technologies Corporation
Myristyltrimethylammonium bromide Sigma Chemical Company 1119-97-7
NP LDS SAMPLE BUF (4X) Life Technologies Corporation
NUPAGE SAMPLE REDUCING AGENT Life Technologies Corporation
Oxygen Airgas USA, LLC 7782-04-7
PARAFORMALDEHYDE 16% SOLUTION, EM GRADE ELECTRON MICROSCOPY SCIENCES
PCS Instrument Calibrator Kit Solutions ARTEL, Inc.
pH 12.46 Buffer Thermo Fisher Scientific
Phthalic anhydride ALFA AESAR 85-04-9
POLY -GUARD FDA 22 Calumet Branded Products, LLC
Polysorbate 80 Sigma -Aldrich Corporation
Potassium chloride, 1M aq. soln. ALFA AESAR 7447-00-7
Potassium dihydrogen phosphate ALFA AESAR 7778-77-0
Potassium hexahydroxoantimonate(V) ALDRICH CHEMICAL COMPANY 12208-13-8
Potassium hydroxide, 0.1N Standardized Solution in methanol ALFA AESAR 67-56-1
Potassium permanganate ALFA AESAR 7722-64-7
Power SYBR Green PCR Master Mix Thermo Fisher Scientific Baltics UAB
PRO SEAL PRO CHEM, INC.
ProKlenz TWO High Performance Acid Detergent Steris Corporation
Quant-T PicoGreendsDNA reagent Life Technologies Corporation 67-68-5
RYDLYME RYDLYME NEW ZEALAND
SELcide 797 Southeastern Laboratories, Inc.
SilverQuest Developer Life Technologies Corporation
SILVERQUEST: SENSITIZER Life Technologies Corporation
SimplyBlue SafeStain Life Technologies Corporation
Sodium (meta)arsenite ALDRICH CHEMICAL COMPANY 7784-06-5
Sodium dodecyl sulfate solution Sigma Chemical Company
Squalene Sigma Chemical Company
STERI-PEROX 6% Veltek Associates, Inc.
SUCCIN IC ACID MELTING POINT STANDARD U. S. Pharmacopeia 110-15-6
Tizma hydrochloride solution Sigma Chemical Company
Tryptic Soy Agar- ICR 30m1 - EXEMPT LETTER EMD Millipore Corporation
TSA with LTHThio cont.-ICR+ - EXEMPT LETTER EMD Millipore Corporation
TURBO DNase(2U/pL) Thermo Fisher Scientific Baltics UAB
Valvoline SAE 10W30 Motor Oil Valvoline Canada Corp
Water ALFA AESAR
Zinc chloride hydrate ALFA AESAR 29604-34-0
2-Propanol Fisher Scientific 67-63-0
Acetic Acid, Glacial HPLC Grade ACS EMD Performance Materials Corp., an Affiliate of Merck KGaA 64-19-7
Acetone ACS VWR International Co. 67-64-1
Acetone HPLC Grade EMD Millipore Corporation 67-64-1
Acetonitrile with 0,1 % (v/v) Formic acid Fisher Scientific 75-05-8
Albumin Standard, 10 X 1 mL Life Technologies Corporation
Ammonium cerium(IV) nitrate Fisher Scientific 16774-21-3
Ammonium oxalate monohydrate Fisher Scientific
Ammonium persulfate Fisher Scientific 7727-54-0
Brilliant Blue R Fisher Scientific 6104-59-2
BSA, FRAC. V, FATTY ACID, NUC, PROT-FREE -EXEMPT LETTER EMD Millipore Corporation
Minimum Essential Medium (MEM) (1X), liquid Life Technologies Corporation
Buffer pH 7.0, Yellow READY TO USE FOR pH <br/>CALIBRATION, <br/>pH 7.00 ± 0.01 at 25° C <br/>N IST Traceable - EXEMPT
LETTER EMD Millipore Corporation

Calcium chloride dihydrate Sigma Chemical Company 10035-04-8
Chloramine T Tihydrate TCI AMERICA 7080504
Citric Acid, Monohydrate Avantor Performance Materials, LLC. 5949-29-1
Clorox Germicidal Bleach The Clorox Company
DECON-SPORE 200 Plus Veltek Associates, Inc.
DECON-SPORE 200 Plus Disinfectant Veltek Associates, Inc.
Dextrose U. S. Pharmacopeia 50-99-7
FlowClean Cleaning Agent Beckman Coulter Ireland Inc.
Fluid A Millipore Corporation 73049-73-7
Glycerol, sterile BIOTECHNOLOGY GRADE VWR Chemicals, LLC 56-81-5
Hydrogen peroxide 35% suitable for use as excipient EMPROVE exp EMD Millipore Corporation
iso-Propyl Alcohol [2-Propanol] GR ACS EMD Millipore Corporation 67-63-0
L-H-Glutamine Avantor Performance Materials, LLC.
LAB ALGICIDE, CLEAR BATH ALGICIDE PolyScience
LOCTITE EA 445 known as LOCTITE Fixmaster Fast Cure Henkel Corporation
LOCTITE LB 8209 DUP OR LU PFPE HIGH PERF known as Dupont Krytox RFE PFPE Lubri Henkel Corporation
L-Phenylalanine TCI AMERICA 63-91-2
L-Tyrosine U. S. Pharmacopeia 60-18-0
Magnesium sulfate heptahydrate Fisher Scientific
MEM NON -ESSENTIAL AMINO ACIDS SOLUTION, (100X) Life Technologies Corporation
m-ENDO agar LES for microbiology EMD Millipore Corporation
MONOBASIC POTASSIUM PHOSPHATE, CRYSTAL, NF Spectrum Chemical Manufacturing Corporation 7778-77-0
Mynstyltimethylammonium bromide Fisher Scientific 1119-97-7
Na-Benzoyl-Larginine ethyl ester hydrochloride Fisher Scientific 2645-08-1
No-Tox Food Grade Clear Grease 2 Bel -Ray Company, LLC
NP TRANSFER BUF (20X) Life Technologies Corporation
NuPAGE MES SDS Running Buffer (for Bis-Tns Gels only) (20X) Life Technologies Corporation
Na-Tosyt-L-lysine chloromethyl ketone hydrochloride Sigma Chemical Company 4272-74-6
Oatey PVC Heavy Duty Clear or Gray Cement OATEY CO.
Obeen OF 2 Castro! (U.K.) Limited
Oxygen, Compressed Gas Universal Industrial Gases Inc
PBS, PH 7.2 Life Technologies Corporation
PEAK Antifreeze + Coolant 50/50 Prediluted Old World Industries, LLC
Perchbric acid 70% VWR International Co. 7601-90-3
Phosphoric Acid Orthophosphoric Acid 85% (w/w) EMD Millipore Corporation 7664-38-2
Pierce BCA Protein Assay Life Technologies Corporation
Poly(ethylene glycol) Sigma Chemical Company 25322-68-3
Polymer Microsphere Suspension Thermo SCIENTIFIC Microgenics Corporation
Nitrogen, refrigerated liquid Praxair, Inc. 7727-37-9
Potassium Chloride Avantor Performance Materials, LLC. 7447-40-7
Proteinase K (from Tritirachium album) solution in Tris/HC! pH 7.5; 0.01 mol,; 600 mAnson-U/ml; for molecular biology EC 3.4.21.14 EMD Millipore Corporation
R-404A National Refrigerants, Inc.
R-407C National Refrigerants, Inc.
Sodium Carbonate Solution, 1N (Certified) Fisher Scientific 497-19-8
Sodium Citrate, Dihydrate Avantor Performance Materials, LLC. 6132-04-3
Sodium hexanitrocobaltate(III) Fisher Scientific 13600-98-1
Sodium Hydroxide, 50%Solution Avantor Performance Materials, LLC.
STERI-PEROX 6% Veltek Associates, Inc.
Sucrose U. S. Pharmacopeia 57-50-1
Sulfanilamide Melting Point Standard U. S. Pharmacopeia 63-74-1
Tetradecyltnmethylammonium bromide for synthesis EMD Millipore Corporation 1119-97-7
Tryptic Soy Broth Millipore Corporation
UN I -WELD Purple Primer -NSF Listed United Elchem Industries c/o Oatey Co.
YSI2363 Potassium Ferrocyanide YSI, a Xylem brand 14459-95-1
ZWITTERGENT 3-14 Detergent -EXEMPT LETTER EMD Millipore Corporation
2-Nitrobenzaldehyde ALFA AESAR
AM2548 PROTEINASE K (20MG/ML)5X1.25ML Life Technologies
Ammonium Oxalate, 4%w/v LabChem, Inc. 6009-70-7
Bleach -Rite Disinfecting Spray with Bleach Current Technologies Inc
BOND -BREAKER TCEP SOLUTION Life Technologies Corporation
Bromophenol Blue, <br/>Sodium Salt GR ACS - EXEMPT LETTER EMD Millipore Corporation
Buffer pH 10.0, Blue EMD Millipore Corporation
Buffer pH 10.0, Blue READY TO USE FOR pH <br/>CALIBRATION, <br/>pH 10.00 t 0.01 at 25° C <br/>N IST Traceable EMD Millipore Corporation
Buffer Solution pH 10.00 Blue LabChem, Inc.
Buffer Solution pH 4.00 Red LabChem, Inc.
Busch VE 101 Vacuum Pump Oil BUSCH INC
Calcium Chloride Anhydrous Desiccant <br/>Powder GR ACS EMD Millipore Corporation 10043-52-4
Calcium Chloride Dihydrate VWR International, LLC 10035-04-8
Carbon Dioxide, Refrigerated Liquid Praxair, Inc. 124-38-9
Cleaning Solution for Cleaning Vapro ELITechGroup Inc.
Clorox Commercial Solutions, Clorox Germicidal Bleach! Clorox Professional Products Company
DPD Free Chlorine Reagent Hach Company
Fluid D Millipore Corporation 73049-73-7
Glutamine U. S. Pharmacopeia 56-85-9
Hexane SPECTRUM LABORATORY PRODUCTS INC. 110-54-3
HYDRANAL-Methanol dry Fluka Chemical Company
Hydrogen peroxide 30% (stabilized) for synthesis EMD Millipore Corporation
Kliberoil 4 UH1-680 N Kliber Lubrication North America L.P.
Klubersynth UH 1 6-100 Kliber Lubrication North America L.P.
N,N-Dimethylfornamide VWR International, LLC 68-12-2
Oxygen, refrigerated liquid Praxair, Inc. 7782-44-7
pH 1.68 Buffer Thermo Fisher Scientific 6100-20-5
Pierce BCA Protein Assay Reagent A Thermo Fisher Scientific, Pierce Biotechnology
POTASSIUM ACETATE VWR International, LLC 127-08-2
POTASSIUM PHOSPHATE DIBASIC VWR International, LLC 7758-11-0
Precision Plus Protein Dual Xtra Standards Bio-Rad Laboratories, Life Science Group
Precision Plus Protein Unstained Standards Bio-Rad Laboratories, Life Science Group
Sodium Bicarbonate Solution, 7.5% Life Technologies Corporation
SODIUM HYDROXIDE VWR International, LLC 1310-73-2
Sodium Hydroxide, 50%Solution Avantor Performance Materials, Inc.
Sodium Phosphate VWR International, LLC 7558-79-0
SODIUM PHOSPHATE MONOBASIC MONOHYDRATE VWR International, LLC 10049-21-5
Sodium Phosphate, Monobasic, Dihydrate GR EMD Millipore Corporation 13472-35-0
SP 510TM Hardness Monitor Buffer Solution for 0.3 Hach Company
Sulfuric Acid GR ACS EMD Millipore Corporation 7664-93-9
Tapmatic Edge Lube ITW Pro Brands
tert-Butanol Honeywell International, Inc. 75-65-0

Trypan Blue stain 0.4% *for use with Countess automated cell counter Life Technologies
Tryptic Soy Broth Alpha Teknova, Inc.
Trypticase Soy Broth - "A" Tube BD DIAGNOSTIC SYSTEMS
WEB PRO Coil Cleaner Kleen Test Products Corp
YSI 1530, 2327, 2328 Lactate Standards YSI, Inc.
MEM NON -ESSENTIAL AMINO ACIDS SOLUTION, (100X) LIQUID Life Technologies
Methanol VWR International, LLC 67-56-1
ACETIC ACID AQUEOUS SOLUTIONS Ricca Chemical Company LLC 64-19-7
Antifoam Solution HyClone Laboratories, Inc.
Bovine Sera VWR International
Buffer pH 7.0, Yellow EMD Millipore Corporation
Buffer Solution, pH 7.0 (Yellow) EMD Chemicals Inc.
Calcium Chloride, Anhydrous, Desiccant, GR, For Drying EMD Millipore Corp.
CytoFLEX Daily QC Fluorospheres Beckman Coulter, Inc.
DECON-QUAT 100 Veltek Associates, Inc.
ES 7X LABORATORY DETERGENT MP Biomedicals, LLC
Ethyl Alcohol 190 -200 Proof USP/ACS/Grain/Synthetic/Kosher/Organic/Cane/Wood PHARMCO PRODUCTS, INC. 64-17-5
Glucose Standards - all concentrations YSI, Inc.
HYDROCHLORIC ACID, >=7.2% (w/w); >=17% (v/v) Aqueous Solutions; DILUTE R, R1 Ricca Chemical Company LLC 7647-01-0
Insulin, Zinc, Human, Recombinant, Pichia pastors EMD Biosciences, Inc. 11061-68-0
IS800.09 12CMSC-Crtrg(0.730 lbs-0.331 KG ACETOXY SEALANT Waterford Plant
L-CYSTINE Sigma Chemical Company 56-89-3
Magnesium Chloride Hexahydrate, EP, BP, USP, FCC EMD Millipore Corp. 7791-18-6
MC 16 LIGHT GRAY LACQUER FOR POWDER T-U CUSTOM-PAK PRODUCTS INC
NUPAGE 4-12% BT GEL 1.0MM10W Life Technologies
Nupage Transfer Buffer (20X) INVITROGEN CORPORATION
o-Phosphoric Acid, 85% w/w, GR EMD Millipore Corp. 7664-38-2
Phosphate Balanced Salt (PBS) Solutions HyClone Laboratories, Inc.
Potassium Phosphate, Dibasic, U.S.P. Avantor Performance Materials, Inc. 7758-11-4
PVTLBL SSPR 6PK DEMKOTE SAFETY RED W.W. Grainger, Inc.
SELamine 2140 Southeastern Laboratories, Inc.
Sodium Chloride, GR EMD Chemicals Inc. 7647-14-5
Sodium Hydroxide Solution (<0.5 %) HyClone Laboratories, Inc. 1310-73-2
Sodium meta-Penodate EMD Millipore Corp. 7790-28-5
Sodium Sulfide, Nonahydrate, GR EMD Millipore Corp. 1313-84-4
Sta Put Hercules Chemical Company Inc.
Sucrose EMD Millipore Corp. 57-50-1
TechniSat w/rechnicloth Wipers ITW Texwipe
Total Alkalinity Indicator Taylor Technologies, Inc.
Tns Buffer, 1 M, pH 8.0, Molecular Biology Grade EMD Millipore Corp. 77-86-1
Tween Polysorbate 20 NF EMD Chemicals Inc. 9005-64-5
WASH SOLUTION -ALIQUOT Life Technologies
WB SEC. ANTI -RABBIT SOLN-ALIQ Life Technologies
YSI 1530 L-Lactate Standard (30 mmol/L) YSI, Inc.
YSI 1531 Glucose (Dextrose) Standard (50 mmol/L) YSI, Inc.
YSI2363 Potassium Ferrocyanide YSI, Inc. 14459-95-1
YSI2392 Sodium Chloride YSI, Inc. 7647-14-5
YSI 2776 Glucose/Lactate Standard YSI, Inc.

Segirus, Inc. Holly Springs Chemical Inventory, Bulk Department
eBinder Product List
Product Name
Sodium chloride Ph.Eur./USP/BP/JP/ENDOTOXIN TESTED
L-Glutamic acid
DEC-AHOL WFI FORMULA
MF-59 Adjuvant
DECON-SPORE 200 Plus
Ethanolamine
Vi-CELL Quad and Single Pak - KIT
Tromethamine
Vi-Cell Concentration Control
Carbon Dioxide (3.00% - 80.5099%), Oxygen (0.0001% - 19.4900%) in Nitrogen
Trypsin rec. 3,5 MU per bottle
Tris hydrochloride
MDCK PFM MEDIUM
Potassium Chloride, EP, BP, DAB, PhFR, USP, FCC
Hypo-Chlor
Koptec Ethanol, 200 Proof
Sodium Bicarbonate
Broadley-James Electrolyte solution for Oxygen Sensors
Lt-Propiolactone
Polyoxyethylene (80) Sorbitan Monooleate
Buffer pH 4.0, Red
Acetone
Carbon Dioxide (0.0001% - 2.999%) in Nitrogen
DECON-AHOL 99%
MDCK PFM MEDIA AGT
Citric Acid 50% SPCL
10% ADCF Antifoam Solution, 8X0.5L
Phosphoric Acid 85% NF/EP
L-Cystine
SODIUM CHLORIDE MULTI-COMPENDIAL
Sodium Chloride (USP/EP)
Potassium dihydrogen phosphate cryst., EMPROVE ESSENTIAL Ph Eur,BP,JPC,NF,E 340
Sodium Hydroxide
Benzonase endonuclease EMPROVE EXPERT
Hydrochloric acid fuming 37% EMPROVE ESSENTIAL Ph Eur,BP,JP,NF
DM133P1C Base Powder w/o L-Glutamine & Glutamate
Capto Core 700, 5 L
TSB for TSB Hold Studies
Kolliphor P 188
ISE Buffer
SODIUM PHOSPHATE MONOBASIC MONOHYDRATE MULTI-COMPENDIAL
Sodium Hydroxide 50% FCC SPCL
Sodium Chloride USP/EP (NaCI)
DECON-Clean Sterile
CETYL TRIMETHYL AMMONIUM BROMIDE
YSI 2357 Buffer Concentrate Kit
STERI-PEROX 6% WIPE
Iron Solution for DM122P/DM133P
SODIUM PHOSPHATE DIBASIC DIHYDRATE MULTI-COMPENDIAL
L-Tyrosine EMPROVE EXPERT Ph Eur,JP,USP
DECON-CLEAN WFI FORMULA AEROSOL
BUFFER Q
10% ADCF Antifoam Solution, 0.5L
Capto Core 700, 60 L
L-Glutamic acid
Sodium hydroxide Multi-Compendial Pellets
STERI-PEROX 6%
L-GLUTAMINE
DECON-QUAT 100 (Use Dilution)
DECON-SPORE 200 Plus Disinfectant
YSI 2363 Potassium Ferrocyanide
Oxygen, Compressed Gas
L-(+}Glutamine
Hydrogen peroxide 35% suitable for use as excipient EMPROVE exp
DECON-SPORE 200 Plus
Nitrogen, refrigerated liquid
Oxygen, refrigerated liquid
Cleaning Solution for Cleaning Vapro
Tryptic Soy Broth
Carbon Dioxide, Refrigerated Liquid
Sodium Hydroxide, 50% Solution
Buffer pH 10.0, Blue
DECON-QUAT 100
L-CYSTINE
Buffer Solution, pH 7.0 (Yellow)
YSI 2392 Sodium Chloride
Magnesium Chloride Hexahydrate, EP, BP, USP, FCC
YSI 1530 L-Lactate Standard (30 mmol/L)
YSI 1531 Glucose (Dextrose) Standard (50 mmol/L)
YSI 2776 Glucose/ Lactate Standard
Location: {Bulk}, Product Status in Location: {In
Use}
Manufacturer
VWR International, LLC
AJINOMOTO CO., INC.
Veltek Associates, Inc.
Seqirus
Veltek Associates, Inc.
Sigma -Aldrich Corporation
Beckman Coulter, Inc.
Avantor Performance Materials, LLC.
Beckman Coulter, Inc.
AIR LIQUIDE
Roche Diagnostics
Sigma Chemical Company
Life Technologies
EMD Millipore Corp.
Veltek Associates, Inc.
DLI
Avantor Performance Materials, Inc.
BROADLEY-JAMES CORP
Ferak Berlin GmbH
EMD Chemicals Inc.
EMD Chemicals Inc.
EMD Chemicals Inc.
Airgas USA, LLC
Veltek Associates, Inc.
Life Technologies Corporation
Hawkins, Inc.
Cytiva Austria
Hawkins, Inc.
Sigma Chemical Company
A&C AMERICAN CHEMICALS LTD.
Cytiva Austria
EMD Millipore Corporation
Cytiva Austria
EMD Millipore Corporation
EMD Millipore Corporation
FUJIFILM Irvine Scientific, Inc.
Cytiva
Cytiva Austria
BASF CORPORATION
Diamond Diagnostics
A&C AMERICAN CHEMICALS LTD.
Hawkins, Inc.
Cytiva Austria
Veltek Associates, Inc.
A&C AMERICAN CHEMICALS LTD.
YSI, Inc.
Veltek Associates, Inc.
IRVINE SCIENTIFIC
A&C AMERICAN CHEMICALS LTD.
EMD Millipore Corporation
Veltek Associates, Inc.
A&C AMERICAN CHEMICALS LTD.
Cytiva Austria
Cytiva
Sigma Chemical Company
Avantor Performance Materials Poland S.A.
Veltek Associates, Inc.
Ajinomoto do Brasil Industria e Comercio de Alimentos Ltda.
Veltek Associates, Inc.
Veltek Associates, Inc.
YSI, a Xylem brand
Universal Industrial Gases Inc
Avantor Performance Materials, LLC.
EMD Millipore Corporation
Veltek Associates, Inc.
Praxair, Inc.
Praxair, Inc.
ELITechGroup Inc.
Alpha Teknova, Inc.
Praxair, Inc.
Avantor Performance Materials, Inc.
EMD Millipore Corporation
Veltek Associates, Inc.
Sigma Chemical Company
EMD Chemicals Inc.
YSI, Inc.
EMD Millipore Corp.
YSI, Inc.
YSI, Inc.
YSI, Inc.
Revision Date
2/26/2020 12:00:00 AM
11/26/2020 12:00:00 AM
5/17/2021 12:00:00 AM
8/31/2016 12:00:00 AM
9/16/2021 12:00:00 AM
6/30/2021 12:00:00 AM
8/4/2021 12:00:00 AM
11/2/2020 12:00:00 AM
8/4/2021 12:00:00 AM
8/12/2020 12:00:00 AM
4/17/2019 12:00:00 AM
1/26/2020 12:00:00 AM
4/28/2015 12:00:00 AM
3/10/2012 12:00:00 AM
2/2/2010 12:00:00 AM
1/25/2017 12:00:00 AM
12/28/2015 12:00:00 AM
6/17/2014 12:00:00 AM
7/25/2007 12:00:00 AM
8/12/2009 12:00:00 AM
6/17/2011 12:00:00 AM
11/3/2011 12:00:00 AM
3/19/2015 12:00:00 AM
2/28/2017 12:00:00 AM
5/13/2021 12:00:00 AM
4/4/2013 12:00:00 AM
3/17/2021 12:00:00 AM
10/28/2015 12:00:00 AM
9/11/2020 12:00:00 AM
11/1/2019 12:00:00 AM
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4/13/2021 12:00:00 AM
2/14/2018 12:00:00 AM
3/15/2021 12:00:00 AM
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12/9/2020 12:00:00 AM
8/26/2019 12:00:00 AM
7/18/2020 12:00:00 AM
6/19/2020 12:00:00 AM
11/30/2015 12:00:00 AM
11/18/2019 12:00:00 AM
4/30/2021 12:00:00 AM
9/28/2018 12:00:00 AM
11/19/2009 12:00:00 AM
8/1/2012 12:00:00 AM
3/30/2012 12:00:00 AM
8/23/2019 12:00:00 AM
6/2/2011 12:00:00 AM
3/15/2016 12:00:00 AM
1/20/2021 12:00:00 AM
1/26/2017 12:00:00 AM
11/30/2020 12:00:00 AM
3/17/2021 12:00:00 AM
8/26/2019 12:00:00 AM
1/14/2020 12:00:00 AM
2/3/2021 12:00:00 AM
8/23/2019 12:00:00 AM
1/16/2019 12:00:00 AM
8/27/2018 12:00:00 AM
3/2/2017 12:00:00 AM
3/22/2018 12:00:00 AM
6/29/2018 12:00:00 AM
7/2/2018 12:00:00 AM
9/27/2017 12:00:00 AM
1/8/2018 12:00:00 AM
10/21/2016 12:00:00 AM
10/21/2016 12:00:00 AM
4/24/2014 12:00:00 AM
4/15/2015 12:00:00 AM
10/13/2016 12:00:00 AM
1/19/2016 12:00:00 AM
1/6/2015 12:00:00 AM
8/21/2014 12:00:00 AM
6/25/2014 12:00:00 AM
6/17/2011 12:00:00 AM
12/11/2013 12:00:00 AM
2/19/2012 12:00:00 AM
3/30/2012 12:00:00 AM
3/30/2012 12:00:00 AM
3/30/2012 12:00:00 AM
CAS # Date Added
1/4/2022
11/23/2021
11/23/2021
11/15/2021
11/10/2021
11/5/2021
10/25/2021
9/9/2021
9/1/2021
6/3/2021
6/3/2021
1185-53-1 6/3/2021
6/3/2021
7447-00-7 6/3/2021
7681-52-9 6/3/2021
6/3/2021
6/3/2021
6/3/2021
6/1/2021
9005-65-6 6/1/2021
6/1/2021
67-641 6/1/2021
7727-37-9 6/1/2021
67-63-0 6/1/2021
6/1/2021
6/1/2021
6/1/2021
766438-2 6/1/2021
6/1/2021
7647-145 6/1/2021
7647-145 6/1/2021
7778-77-0 6/1/2021
1310-73-2 6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
10049-21-5 6/1/2021
6/1/2021
7647-14-5 6/1/2021
6/1/2021
57-09-0 6/1/2021
6/1/2021
6/1/2021
6/1/2021
10028-24-7 6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
56-85-9 6/1/2021
6/1/2021
6/1/2021
14459-95-1 6/1/2021
6/1/2021
6/1/2021
6/1/2021
6/1/2021
7727-37-9 6/1/2021
7782-047 6/1/2021
6/1/2021
6/1/2021
124-38-9 6/1/2021
6/1/2021
6/1/2021
6/1/2021
56-89-3 6/1/2021
6/1/2021
7647-145 6/1/2021
7791-18-6 6/1/2021
6/1/2021
6/1/2021
6/1/2021

Se girus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Table of Contents
1. Purpose and Scope 2
2. Responsibilities 2
3. Hazards, Materials, and Equipment 2
3.1 Hazards 2
3.2 Materials 3
3.3 Equipment 3
4. Abbreviations and Definitions 3
4.1 Abbreviations 3
4.2 Definitions 4
5. Execution 5
5.1 Preparation for Disinfection 5
5.2 Pre -Cleaning of Rooms 7
5.3 Ceiling Disinfection 8
5.4 Wall and Window Disinfection 11
5.5 Countertops, Door Handles, Windows, Benches, Chairs, Stainless Steel Room
Surfaces, Sterility Zone B Biohazard Waste Container Interior 14
5.6 Cleaning and disinfecting WFI Point of Use Sink and WFI Funnel 16
5.7 Floor Disinfection / Weekly Floor Cleaning 17
5.8 MicronSwep Rinsing and Sterilization 21
6. Reference Documents 22
7. Appendix/Appendices 22
8. Regulatory Commitments 23
9. Change Description 23
Print Date(UTC): 14-Dec-2021 22:12:36
Page 1 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
1. Purpose and Scope
Purpose:
To describe disinfection frequency for room and work surfaces within clean zones. Also to
provide instructions for preparation of disinfection solutions and operation of the Micron Swep
system. This SOP must be read and used in conjunction with area -specific disinfection logs.
Scope:
This SOP applies to Bulk, Fill Finish (Building 04 and Building 05), Small Scale Filling Zone C,
D and E, (Building 09), Quality Control, and Warehouse Buildings at Holly Springs.
This SOP does not apply to Viral Pilot Plant (VPP) and Technical Development (TD) in
Building 09, Small Scale Filling Zone A RABS and Zone B suite, (Building 09). These areas
are addressed under SOP-000115723, "SSF Disinfection of the Zone A RABS and Zone B fill
suite". Cleaning and disinfection of equipment is not within the scope of this document.
a
2. Responsibilities
Area Manager:
• Ensure personnel using SOP are properly trained and training is documented.
• Ensure cleaning of the controlled areas takes place as described by this procedure.
Operator or GMP Contract Service Personnel:
• Perform operations listed in this SOP.
• Ensure completion of training and submission of training documentation.
• Recording performed disinfection operations in appropriate log books.
• Ensure proper implementation of disinfection and disinfectant use as specified in this SOP.
• Ensure only approved and unexpired disinfectants are used.
3. Hazards, Materials, and Equipment
3.1 Hazards
Adherence to the EHS Management System and applicable Policies, Standards and
Procedures covering EHS is mandatory.
Hazard Selection
Control Statement
Chemical
6% hydrogen peroxide (Steri-perox), quaternary ammonium (decon-quat), 70%
IPA. Gloves, goggles / face shield when diluting and dispensing solutions.
Respirators.PAPR are available for use when cleaning with Steri-perox.
Slips/Trips
Floors are wetted in this procedure. Non -slip safety shoes, wet floor signs,
personnel communication.
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Page 2 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
3.2 Materials
• AWFI
• Decon-Quat, sterile SimpleMix (SAP#: 10014020)
• Decon-Quat, sterile 8 oz concentrate (SAP#: 10021677)
• Decon-Spore 200, sterile (SAP#: 10014011)
• Decon-ahol aerosol 70%, sterile (SAP#: 10014014) — To be used in Zones A and B ONLY
• Decon-ahol 70%,16oz TriggerSpray WFI Formula (SAP#: 10022507)
• Decon-ahol 70%,32oz TriggerSpray WFI Formula (SAP#: 10022508)
• Decon-Clean, sterile SimpleMix (SAP#: 10014018) — Residue remover
• Decon-Clean, sterile 4 oz concentrate (SAP#: 10021676) — Residue remover
• Steri-Perox 6%, sterile (SAP #: 10014760) — Sporicidal
• Steri-Perox Sterile Spray 16oz, (SAP#: 10014118) — Sporicidal
• Mop Head, MicronSwep Reusable (SAP #: 10022829)
• Bucket with spigot
3.3 Equipment
• Micron Swep System
a
4. Abbreviations and Definittb
4.1 Abbreviations
• AWFI Ambient Water for Injection
• CFR Code of Federal Regulations
• FF Fill Finish
• HEPA High Efficiency Particulate Air
• ICH International Conference on Harmonization
• IPA Isopropyl Alcohol
• ISO International Organization of Standardization
• N/A Not Applicable
• NLT No Less Than
• PAPR Purified Air Powered Respirator
• SOP Standard Operation Procedure
• SSF Small Scale Filling
• WFI POU Water for Injection Point Of Use or WFI Funnel
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Page 3 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
4.2 Definitions
• Cleaning: Removal of waste, debris, and/or residue
• Contractor Service Provider: Current GMP Cleaning Contractors
• Daily: Once every calendar day when a day is defined as 24 ± 12 hours
• Disinfection: Reduction of micro-organisms using anti -microbial agents
• MicronSwep Unit: A bucket system used to hold disinfectant and saturate reusable mops.
• Monthly: Once every calendar month
• Quarterly: Once every three months ± 15 days
• Semi -Annually: Once every six months ± 15 days
• Weekly: Once every calendar week when a calendar week begins on Sunday
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Page 4 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
5. Execution
5.1 Preparation for Disinfection
Step
Description
1
2.
Determine Disinfection Regimen.
A. The frequency of disinfection activities will be performed based on the
requirements of each individual area. Surfaces in zones with a higher
classification may be disinfected at higher frequencies. The guidelines below
represent the minimum disinfection requirements.
B. Determine which type of disinfection will take place as scheduled below:
1. Determine the Zone of the area to be disinfected using Appendices B to I.
Use Appendix A to determine if those areas will require a daily, weekly,
monthly, or quarterly disinfection and what disinfection agent(s) will be used.
2. Weekly and monthly disinfections take the place of a daily disinfection.
3. Monthly and quarterly disinfections take the place of a daily or weekly
disinfection.
4. Quarterly and Semi-annual disinfections take the place of a daily, weekly, or
monthly disinfection.
Dispense Disinfection Solution into Micro. ,Swep System.
A. Obtain a MicronSwep unit.
Aq)
c</
1
1
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Page 5 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
B. If using Decon-Quat 8 oz concentrate, dispense ENTIRE contents into dedicated
dilution bucket.
1. In dedicated dilution bucket, fill bucket up to the 4 gallon fill line with
WFI from WFI drop, per SOP-000081780, Operation of WFI Drops.
2. Use the spigot and add contents of bucket into the lower rear bucket of
the MicronSwep unit.
3. Record in FORM1-000083487, Concentrate Dilution Logbook,
the cleaning concentrate used, lot number, expiration, amount of WFI
dispensed in gallons, that the entire concentrate bottle was dispensed.
4. Ensure a second person is present when executing 5.1.2.B steps
1 and 2, and the actions are verified and documented correctly in the
logbook.
5. Designated dilution bucket should be rinsed with WFI, wiped down
with low lint wipes, disinfected with Steri-Perox 6%, and positioned
upside down to dry after each use.
C. If using SimpleMix, prepare to dispense up to 5 Gallons of the ready to use
disinfectant solution into the lower rear bucket of the MicronSwep unit.
1. Remove cap from top of Simple Mix container and peel away film.
2. Pull up on white tab. This releases the vent allowing the concentrate
to drain into the container. Swirl container as directed on lid.
D. / Complete status tag found in FORM1-000083485- Portable Cleaning Vessel
In Use and attach tag to MicronSwep unit. Be sure to include the disinfectant
batch number, disinfection agent name and expiry.
E. The expiry on the solution dispensed into the Micronswep unit is 24hrs from the
time it was dispensed.
3.
Disinfection
A. Proceed to areas to be disinfected.
B. Rooms should be disinfected moving from Zones of higher classification (Zone
B) to Zones of lesser classification (Zone E) in a given area when possible.
Reference Appendices B-I for the classification of each room.
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
5.2 Pre -Cleaning of Rooms
Step
Description
1.
Waste Removal
A. Place waste material into the designated area waste bin and stage in return
airlocks.
2.
Debris Removal
A. Inspect floor for debris. Focus on coving along walls and areas of flooring near
equipment and low level return grills.
B. For monthly cleaning, inspect the floor under the Sartorius portable scales for
debris. Refer to Appendix K for the method on how to prepare scales for moving.
1. ' Record "scale moved for cleaning" in the Sartorius scale logbook.
C. Remove debris by using a low -lint wipe to pick up debris and dispose in a waste
bin. To minimize the generation of airborne particulates, the sweeping of the
floors in clean areas and associated rooms is prohibited.
D. Disinfect gloves with IPA (Zone B — aerosol can only) after removing debris from
the floor. Proceed to airlock and don new gloves. Disinfect new gloves with IPA.
E. If any material is spilled, wipe up using IPA and a low -lint wipe.
3.
Safety Notification
A. Display a wet floor sign or status tag at the entry to the room/area where the
disinfection operation is to be performed.
B. Ensure disinfection will not interfere with operations in the area.
4.
Room Disinfection
A. Surfaces are disinfected in the order specified below. Reference Appendix A for
frequency of disinfection. The surfaces that will require disinfection will vary with
the type of disinfection (daily, weekly, monthly, quarterly, or semi-annual
disinfection) required. Proceed to the section below for instructions on the
disinfection required.
1. Ceiling
2. Walls/Windows
3. Counters/Door Handles/Benches/Chairs/Stainless Steel Room Surfaces
4. WFI POU sink and or WFI Funnels
5. Floors
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Page 7 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
5.3 Ceiling Disinfection
Step
Description
1.
Pre -disinfection verification
A. Ensure room has been pre -cleaned.
B. Verify that MicronSwep unit is ready for use.
1. Ensure proper disinfection agent has been dispensed for the area that is
being disinfected per Appendix A and that FORM1-000083485- Portable
Cleaning Vessel In Use has been completed and attached to the
MicronSwep unit.
2.
Ceiling Disinfection
A. Record the disinfection start
B. Don face shield.
C. Start at the rear of the area being
doors. Lights and supply grills
Note: Disinfection of supply grills
disinfection solution to contact
D. Remove the mop from the poly
1. Keep the handle across
thumb and forefinger and
grey end of the frame should
2. Holding the mop by finger
gently pull the mop completely
4,1
E. Submerge the mop in the disinfectant
ensure saturation of the mop.
F. Remove the mop from the bucket
necessary.
time in the logbook.
disinfected and proceed
are included in ceiling disinfection.
must be done with caution.
HEPA filters.
bag and place it onto the
your body, hold the mop
close your hand around
point down towards
loop first place the grey
over the frame.
toward the entry
Do not allow
frame.
frame between your
the handle. Attention:
the floor
clip into the mop, then
10 seconds to
on sieve as
r ---,
i
solution for approximately
and dab off excess solution
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Step
Description
G. When mop stroke no longer leaves a surface visibly wet, install a new mop head.
1. Place the mop frame between thumb and forefinger and put two fingers
through the loop on the mop.
2. Gently pull the mop upwards and remove the frame out of the mop.
3. Place the used mop in the bag on the trolley.
f
11
H. Hold the mop against the ceiling.
I. Move the mop in a straight line, applying even pressure.
J. Use strokes that overlap approximately 1/3rd of the previous stroke to ensure
coverage until the entire ceiling has been covered. Reference Appendix J.
Note: Mop heads should be changed if they become visibly soiled or when
moving to an area of higher classification (i.e. Zone C) after using the
mop head to disinfect an area of lesser classification (i.e. Zone D).
3.
Contact Time
A. Ensure disinfectant is not removed from the surface prior to the contact time
being met.
1. NLT 1 minute - Decon-Spore or Steri-Perox
2. NLT 5 minutes - Decon-Quat
B. If using Decon-Spore, proceed to rinsing per step 5.3.4. Otherwise, continue to
step 5.3.5.
4.
Ceiling Rinsing
A. If using Decon-Spore, after the NLT 1 minute contact time, the ceiling must be
rinsed with AWFI.
1. Repeat step 5.3.2 using AWFI.
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Page 9 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
5.
Documentation
A.
Note:
Ensure the disinfection start & end time of ceiling disinfection, type of
disinfection (Daily, Weekly, Etc.), cleaning/disinfectant agent, lot number, and
expiry have been recorded in the room cleaning / disinfection logbook.
In order to perform the page review in the cleaning logbook, the
individual must confirm that the cleaning entries on that page were
performed at the proper frequencies.
Cleaning/Disinfect Agents Used
Assigned Expiration
Decon-Quat
Decon-Spor
Decon-Clean
Steri-Perox Liquid
Manufacturer
Expiration
Steri-Perox Spray
70% IPA
I Month from Date Opened
per SOP-000076247
6.
Wall Disinfection
A. Disinfect walls per step 5.4 once Ailing disinfection has been completed.
Print Date(UTC): 14-Dec-2021 22:12:36
Page 10 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
5.4 Wall and Window Disinfection
Step
Description
1.
Pre -disinfection verification
A. Verify that there are no other surfaces in the room that are required to be
disinfected prior to walls and windows per step 5.2.4.
B. Ensure room has been pre -cleaned.
C. Verify that MicronSwep unit is ready for use.
1. Ensure the proper disinfection agent has been dispensed for the area that
is being disinfected per Appendix A and that FORM1-000083485- Portable
Cleaning Vessel In Use has been completed and attached to the
MicronSwep unit.
2.
Wall and Window Disinfection
A. If this is the first surface being cleaned, record the disinfection start time in
the logbook.
B. Start at the rear of the area being disinfected and proceed toward the entry
doors. Doors, windows, return and supply grills are included in wall disinfection.
C. Perform disinfection with the MicronSwep as follows:
D. Note: Disinfection of supply grills must be done with caution. Do not allow
disinfection solution to contact HEPA filters or wall clocks.
E. Remove wall clock(s) from wall, if present in the area.
F. Remove the mop from the poly bag and place it onto the frame.
1. Keep the handle across your body, hold the mop frame between your
thumb and forefinger and close your hand around the handle. Attention:
grey end of the frame should point down towards the floor
2. Holding the mop by finger loop first place the grey clip into the mop, then
gently pull the mop completely over the frame.
lilt ,
r
0 ..) _______
._ /
G. Submerge the mop in the disinfectant solution for 10 seconds.
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Step
Description
H. Remove the mop from the bucket and dab off excess solution on sieve as
necessary.
I. When a mop stroke no longer leaves a surface visibly wet, install a new mop
head:
1. Place the mop frame between thumb and forefinger and put two fingers
through the loop on the mop.
2. Gently pull the mop upwards and remove the frame out of the mop.
3. Place the used mop in the bag on the trolley.
• f.
•
J. Hold the mop toward. he v. all, starting at the highest position on the wall.
K. Move the mop tc,var,! the door, applying even pressure.
L. Use strokes that . ' aria, approximately 1/3rd of the previous stroke to ensure
coverage until the ei,'re ceiling has been covered. Reference Appendix I.
M. Repeat until entire surface has been covered.
N. Remove the wall clock(s) from wall, if present in area.
Note: Mop heads should be changed if they become visibly soiled or when
moving to an area of higher qualification (i.e. Zone C) after using the
mop head to disinfect an area of lesser qualification (i.e. Zone D).
O. Wipe wall clock(s) with 70% IPA (Zone B — aerosol can only) and replace on the
wall.
3.
Contact Time
A. Ensure the disinfectant is not removed from the surface prior to the contact time
being met.
1. NLT 1 minute - Decon-Spore or Steri-Perox
2. NLT 5 minutes - Decon-Quat
3. NLT 5 minutes - Decon-ahol
B. If using Decon - Spore, proceed to rinsing per step 5.4.4. Otherwise, continue to
step 5.4.5.
Print Date(UTC): 14-Dec-2021 22:12:36
Page 12 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
4.
Wall Rinsing
A. If using Decon-Spore, after the NLT 1 minute contact time, the walls must be
rinsed with AWFI.
1. Repeat section 5.4.2 using AWFI.
5.
Documentation
A.
Note:
,
Ensure the disinfection start & end time of the wall and window disinfection,
if this is the first surface being cleaned, type of disinfection (Daily, Weekly, Etc.),
cleaning/disinfectant agent, lot number, and expiry have been recorded in the
room cleaning / disinfection logbook.
In order to perform the page review in the cleaning logbook, the
individual must confirm that the cleaning entries on that page were
performed at the proper frequencies.
Cleaning/Disinfect Agents Used
Assigned Expiration
Decon-Quat
Decon-Spor \
Decon-Clean
Steri-Perox Liquid C 4
Manufacturer
Expiration
Steri-Perox Spray
70% IPA 0
1 Month from Date Opened
per SOP-000076247
6.
Countertop, Door handles, Benches, Chairs, Stainless Steel Room Surface Disinfection
A. Disinfect countertops, door handles, and benches per step 5.5 once wall
disinfection has been completed.
Print Date(UTC): 14-Dec-2021 22:12:36
Page 13 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
5.5 Countertops, Door Handles, Windows, Benches, Chairs, Stainless Steel Room
Surfaces, Sterility Zone B Biohazard Waste Container Interior
Step
Description
1.
Pre -disinfection verification
A. Verify that there are no other surfaces in the room that are required to be
disinfected first per step 5.2.4.
B. Ensure room has been pre -cleaned.
2.
Disinfecting countertops, door handles, windows, benches, chairs, stainless steel room
surfaces and Sterility Zone B biohazard waste container interior.
Note: For Sterility Zone B biohazard waste container interior, it is only necessary
to spray the disinfectant on the interior surfaces.
A. If this is the first surface being cleaned, record the disinfection start time in
the logbook.
B. Spray disinfectant on the target surface. 'A
C. Wipe surface with low -lint wipe, using unidirectional strokes.
D. Use strokes that overlap approximately 1/3rd of the previous stroke to ensure
coverage until the entire surface has been covered. Reference Appendix J.
E. Replace wipes as necessary.
F. Repeat process until entire to get , 'urface has been covered.
3.
Contact Time
A. Ensure the disinfectant is not removed from the surface prior to the contact time
being met. )11. NLT 1 minute Decon-Spore or Steri-Perox
2. NLT 5 minutes - Decon-Quat
3. NLT 5 minutes — Decon-ahol
B. If using Decon-Spore, proceed to rinsing per step 5.5.4. Otherwise, continue to
step 5.5.5.
4.
Surface Rinsing
A. If using Decon-Spore, after the NLT 1 minute contact time, the countertops, door
handles, windows, benches, chairs, and stainless steel room surfaces must be
rinsed with AWFI.
1. Repeat section 5.5.2 using AWFI.
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Page 14 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
5.
Documentation
A.
Note:
Ensure the disinfection start and end time, if this is the first surface being
cleaned, type of disinfection (Daily, Weekly), cleaning/disinfectant agent, lot
number and expiry have been recorded in the room cleaning / disinfection
logbook.
In order to perform the page review in the cleaning logbook, the
individual must confirm that the cleaning entries on that page were
performed at the proper frequencies.
Cleaning/Disinfect Agents Used
Assigned Expiration
Decon-Quat
Decon-Spor
Decon-Clean
Steri-Perox Liquid
Manufacturer
` Expiration
Steri-Perox Spray �`
70% IPA __
1 Month from Date Opened
per SOP-000076247
,
6.
WFI POU Sink and Funnels
A. Disinfect WFI POU sink and funnels per step 5.6 once countertops, door handles,
windows, benches, chairs, stainless steel room surfaces disinfection has been
completed. _ _
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Page 15 of 43
Document Number: SOP-000081283
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Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
5.6 Cleaning and disinfecting WFI Point of Use Sink and WFI Funnel
Step
Description
I.
Cleaning of WFI sink/ WFI Funnel
A. Verify that there are no other surfaces in the room that required disinfection first
per step 5.2.4.
B. Remove and dispose of any debris from WFI sink and or WFI POU funnel.
C. Disinfect WFI POU funnels/ sinks:
NOTE: If working in the infectious suites, ensure to don a face mask before
actuating the sink valves.
1. Before pouring Steri-perox down the drain, actuate the sink valves.
2. Pour'/2 gallon of Steri-perox down the sink/funnel drain, ensuring contact
on all sides of the drain.
3. Spray Steri-Perox in the sink and funnels allowing contact on all parts.
4. Wipe the sink/ funnels using low -lint wipes
D. To avoid rusting rinse using AWFI.
2.
Contact Time
A. Ensure the disinfectant is not removed from the surface prior to the contact time
being met.
1. NLT 1 minute - Steri-Perox.
3.
Documentation
A.
Note:
kri
at
Ensure the disinfection start and end time, if this is the first surface being
cleaned, type of disinfection (Daily, Weekly), cleaning/disinfectant agent, lot
number and expiry have been recorded in the room cleaning / disinfection
logbook.
In order to perform the page review in the cleaning logbook, the
individual must confirm that the cleaning entries on that page were
performed at the proper frequencies.
Cleaning/Disinfect Agents Used
Assigned Expiration
Steri-Perox Spray
70% IPA
1 Month from Date Opened
per SOP-000076247
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Page 16 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
5.7 Floor Disinfection / Weekly Floor Cleaning
Step
Description
1.
Pre -disinfection verification
A. Verify that there are no other surfaces in the room that required disinfection first
per step 5.2.4.
B. Ensure room has been pre -cleaned.
C. Verify that MicronSwep unit is ready for use.
1. Ensure the proper disinfection/cleaning agent has been dispensed for the
area that is being disinfected per Appendix A and that FORM1-
000083485- Portable Cleaning Vessel In Use has been completed and
attached to the MicronSwep unit..
2.
Floor Disinfection
A. If this is the first surface being cleaned, record the disinfection start time in
the logbook.
B. Start at the rear of the area requiring disinfection and proceed toward the entry
doors.
C. When performing a Full Room cleaning per Appendix A, perform the following:
1. Remove the floor drain covers using a low -lint wipe or tool to avoid
touching the cover. Remove the strainer using a low -lint wipe to avoid
touching the strainer. Pour 1 gallon of Steri-perox slowly into the drain,
ensuring that it contacts all surfaces within the drain.
2. Dispose of any waste and debris in the strainer. Proceed to disinfect
strainer and drain cover by spraying all surfaces with Steri-perox and
wiping them down with a low -lint wipe.
3. Replace strainer and drain cover.
4. Pour'/2 gallon of Steri-perox down any sink drain in the area, ensuring that
it contacts all surfaces within the drain.
5. Before pouring Steri-perox down the sink drain, actuate the sink valves
and when disinfection is complete ensure that these valves are closed.
6. Disinfect gloves with IPA (Zone B — aerosol only). Proceed to airlock and
don new gloves. Disinfect new gloves with IPA.
D. Remove the mop from the poly bag and place it onto the frame.
1. Keep the handle across your body, hold the mop frame between your
thumb and forefinger and close your hand around the handle. Attention:
grey end of the frame should point down towards the floor
2. Holding the mop by finger loop first place the grey clip into the mop, then
gently pull the mop completely over the frame.
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
E. Submerge the mop in the disinfectant solution for 10 seconds.
F. Remove the mop from the bucket and dab off excess solution on sieve as
necessary.
G. After cleaning approximately 250 square feet of floor surface, determine if
the mop is still leaving the surface visibly wet. If not, install a new mop head:
NOTE: Reference Appendices B through I for number of mops required
per room. Reference Appendix L for example of 250 sq ft in a room.
1. Place the mop frame between thumb and forefinger and put two fingers
through the loop on the mop.
2. Gently pull the mop upwards and remove the frame out of the mop.
3. Place the used mop in the bag on the trolley.
H. Hold the mop against the floor.
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
I. Apply disinfectant using an S-movement and spreading the disinfectant evenly
on the floor starting from the farthest point and progressing towards the point
where mops need to be change for more disinfectant needs to be applied.
J. Ensure the arrow on the frame of the mop always points towards the cleaning
direction.
K. Continue with overlapping
Reference Appendix J
Note: Mop heads should
moving to an area
mop head to disinfect
strokes until the entire floor has been mopped.
be changed if they become visibly soiled or when
of higher classification (i.e. Zone C) after using the
an area of lesser classification (i.e. Zone D).
3.
Contact Time
A. Ensure the disinfectant is not removed from the surface prior to the contact time
being met.
1. If using Decon-Spore: ensure NLT 1 minute contact time for Decon-Spore
before proceeding to Floor Rinsing step 5.7.4.
2. If using Steri-Perox or Decon-Quat: Leave disinfectant on the floor to dry
after application, proceed to step 5.7.5
B. If using Decon-Spore, proceed to rinsing per step 5.7.4. Otherwise, continue to
step 5.7.5.
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
4.
Floor Rinsing
A. If using Decon-Spore, after the NLT 1 minute contact time is met, the floor must
be rinsed with AWFI.
B. Start at the rear of the area/room being rinsed and proceed toward the entry
doors.
C. Remove the mop from the poly bag and place it onto the frame.
1. Keep the handle across your body, hold the mop frame between your
thumb and forefinger and close your hand around the handle. Attention:
grey end of the frame should point down towards the floor
2. Holding the mop by finger loop first place the grey clip into the mop, then
gently pull the mop completely over the frame.
1 Y
4 r
.;
•
5C
D. Submerge the mop in the AWFI for approximately 10 seconds to ensure
saturation of the mop.
E. Remove the mop from the bucket and dab off excess AWFI on sieve as
necessary.
F. Apply AWFI using an S-movement and spreading the disinfectant evenly on the
floor starting from the farthest point and progressing towards the point where
mops need to be change for more disinfectant needs to be applied.
G. Submerge the mop in AWFI as needed to rewet.
H. Record the disinfection end time.
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Page 20 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Step
Description
5.
Documentation
A.
Note:
Ensure the disinfection start & end time, if this is the first surface being
cleaned and end time of the floor disinfecting, type of disinfection (Daily, Weekly,
Etc.), cleaning/disinfectant agent, lot number and expiry have been recorded
the room cleaning / disinfection logbook.
In order to perform the page review in the cleaning logbook, the
individual must confirm that the cleaning entries on that page were
performed at the proper frequencies.
in
Cleaning/Disinfect Agents Used
Assigned Expiration
Decon-Quat
Decon-Spor
Decon-Clean
Steri-Perox Liquid
Manufacturer
Expiration
Steri-Perox Spray •;
70% IPA
(Zone B — aerosol can only)
_
1 Month from Date Opened
per SOP-000076247
6.
Disinfection agent disposal
A. Disinfectant is disposed of at the completion of disinfection or when necessary to
switch to another disinfectant. It is not necessary to dispose of disinfectant when
proceeding to another room, if the same disinfectant is required and the room is
same or lower classification.
5.8 MicronSwep Rinsing a. Ste ilization
Step
1.
Description
MicronSwep Rinsing
A. Rinse the buckets with WFI when switching disinfecting solutions or when
disinfection is complete for the day.
B. Discard AWFI into floor drain.
C. Dry the buckets with low lint wipe.
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Page 21 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
6. Reference Documents
• POL-000091471, Facillities Utilities and Equipment
• FORM1-000078290, Room Cleaning/Disinfection Logbook,
• FORM1-000078291, Bulk Zone E Room Cleaning/Disinfection Logbook,
• FORM1-000078366, Cleaning/Disinfection Logbook for Bulk Zone D and QC Sterility
Rooms,
• FORM1-000083485, Portable Cleaning Vessel In Use
• FORM1-000083487, Concentrate Dilution Logbook
• FORM1-000078295, Cleaning/Disinfection Logbook for Bulk Zone C, Fill Finish, SSF, QC
PCR, and QC Virology Rooms
• SOP-000076247, Materials Transfer
• SOP-000081780, Operation of WFI Drops
• SOP-000082005, Fill Finish Product Change Over Procedure
• VAL-000099622, Summary Report for Disinfectant Efficacy Testing
• SOP-000076213, Quality Control Laboratory Cleaning for Non -Classified Areas
7. Appendix/Appendices
• Appendix A, Disinfection Frequency and Disinfection Agents
• Appendix B, Bulk 3rd Floor Zones & Square Footage
• Appendix C, Bulk 1st Floor Zones & Square Footage
• Appendix D, Bulk 2nd Floor Zones & Square Footage
• Appendix E, Warehouse 1st Floor Zones & Square Footage
• Appendix F, Fill Finish 1st Floor Zones & Square Footage
• Appendix G, QC Lab 2nd Floor Zones & Square Footage
• Appendix H, Fill Finish, SSF Building 09, 1st Floor Zones & Square Footage
• Appendix I, Fill Finish Building 05, 1st Floor Zones C, D, and E and Square Footage
• Appendix J, Overlapping Disinfection Method
• Appendix K, Method for Moving the Sartorius Portable Scales
• Appendix L, Square footage examples
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Page 22 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
8. Regulatory Commitments
Regulatory commitments must not be removed when the SOP is revised.
Version
DR / CC /
CAPA #
Change History
N/A
N/A
N/A
9. Change Description
Change Control #
CC 1085927
Changes Made
Reason
1.
Updated Appendix A & B to include new media suite
areas.
1.
CC 1085927
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix A: Disinfection Frequency and Disinfection Agents**
Zone
Performed
By
Floors
Walls,
Windows,
Floors
Ceilings, Walls, Windows,
Floors, Drains, WFI
Sink/funnels, Under
Portable Scales (Full
Room)
Counters, Door
Handles, Benches,
Chairs, Stainless
B
(QC)
Internal
Personnel
Post
Use/Minimum
once per 7 day
period when not
in use
Decon-Quat
Post Use /
Minimum Once
per 7 day period
Decon-Quat
Monthly
Steri-Perox
Monthly
Steri-Perox
Post Use / Minimum
once per 7 day period
when not in use
Steri-Perox
C
Contract
GMP
Service
Provider
Daily
Decon-Quat
Weekly
Decon-Quat
Month!?Weekly
Steri-Perox
Monthly
Steri-Perox
Steri-Perox
Daily
Decon-ahol
D
Contract
GMP
Service
Provider
Daily
Decon-Quat
Weekly -1Fill
Finish
Decon-Qua#
Monthly3
Steri-Perox
Monthly
Steri-Perox
Weekly'
Steri-Perox
Daily
Decon-ahol
E
Contract
GMP
Service
Provider
Weekly2
Decon-Quat ( SSF
bldg.09)
Steri-Perox (Bulk)
Quarterly
Steri-Perox
Semi-annually
Steri-Perox
Semi-annually
Steri-Perox
Quarterly
Steri-Perox
Weekly2
Steri-Perox
E (B04
& B05
only)
Contract
GMP Service
Provider
Weekly2
Decon-Quat
N/A. See next column for
Wall, Window, Floor
cleaning in Zone E, B05
Semi-annually
Steri-Perox
Weekly2
Steri-Perox
Semi -Annually
Steri-Perox
**Decon-Spore 200 may be used in place of Decon-Quat, Steri-Perox, and IPA as necessary
due to situations including, but not limited to, adverse environmental monitoring results, area
startup, and construction activities.
o Decon-Quat and Decon-ahol are qualified as general use disinfectants.
o Decon-Spore and Steri-perox are qualified as sporicidal disinfectants.
1 Weekly cleaning in Zone D only applies to Fill Finish (Building 04 and Building 05) and SSF (Buiding 09)
2 Weekly cleaning in Zone E only applies to Fill Finish (Building 04 and Building 05), SSF (Building 09) and Bulk.
See table for appropriate disinfectant use.
3 Monthly cleanings in rooms 3.3090/ 3.3091/ 3.3092/3.3096/ 3.3097/3.3097A/3.3098/ 3.3099 will be performed
twice a month.
4 Monthly cleanings in rooms 3.3093/ 3.3094 / 3.3095 will be performed twice a month.
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Page 24 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Fill Finish Product Changeover Cleaning of Formulation Suite 4.1028
Type of Processing*
Surfaces
Ceilings, Walls, Windows, Floors, Drains, Under Portable
Scales, Counters, Door Handles, Benches, Chairs,
Stainless (Full Room)
Closed Processing
No additional product changeover cleaning required.
Open Processing
Decon-Clean
Refer to SOP-000082005, "Fill Finish Product Changeover", for open/closed product details
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Page 25 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix B: Bulk 3rd Floor Zones & Square Footage
Room
Zone
Square ft.
# of Mops
Cell Culture Expansion Lab(3170)
C
1292
6
Cell Culture Expansion Lab Gowning(3171)
C
Cell Culture Expansion Lab Equipment Airlock(3172)
C
Cell Lab 1(3173)
C
Cell Lab 2(3174)
C
Cell Culture Exit Airlock(3175)
C
Media Small Volume Solution Prep Gowning(3093)
C
309
2
Media Small Volume Solution Prep Material Airlock(3094)
C
Media Small Volume Solution Prep(3095)
C
Cell Culture Exit Airlock(3176)
D
36
1
Cell Culture(3130)
D
4646
23
Cell Culture Gowning(3131)
D
605
3
Cell Culture Material Airlock(3132)
D
Cell Culture Control Room(3133)
D
Cell Culture Storage(3134)
D
Cell Culture Jan/Tool(3135), (3136)
D
Buffer Prep(3070)
D
1691
8
Buffer Prep Gowning(3071)
D
Buffer Prep Material Airlock(3072)
D
Buffer Prep Weigh/Dispense(3073)
D
Buffer Prep Storage(3074)
D
Buffer Prep Exit Airlock(3075)
D
PFM Media Prep/Charging(3090)
D
1982
9
PFM Media Prep Gowning(3091)
D
PFM Media Prep Material Airlock(3092)
D
Media Prep Weigh/Dispense(3096)
D
PFM Media Prep Exit Personnel Airlock(3097)
D
PFM Media Prep Degowning(3097A)
D
PFM Media Prep Exit Airlock(3098, 3099)
D
Buffer Charging(3050)
E
4547
15
CDM Cold Media Charging (3100)
E
99
1
Stairwells(3003, 3004, 3005, 3006, 3007)
E
216 each
1
Corridor & Supervisor Offices (3023, 3140, 3150, 3160)
E
1975
8
Corridor & Jan. Closet, Storage, Airlock (3022, 3041, 3230, 3220)
E
2380
8
Return Jan. Closet(3025, 3200, 3190, 3180)
E
628
2
Return Corridor(3024, 3250, 3015)
E
1852
6
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Page 26 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix B: Bulk 3rd Floor Zones & Square Footage
—13- II
Zone E
Zone it
44/cLgr
Lone C.
Print Date(UTC): 14-Dec-2021 22:12:36
Page 27 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix C: Bulk 1st Floor Zones& Square Footage
Room
Zone
Square ft.
# of mops
Final Purification 1(1240)
C
2025
10
Final Purification 1 Gowning(1242)
C
Final Purification 1 Material Airlock(1244)
C
Final Purification 1 Jan/Tools(1245)
C
Final Purification 1 Control Room(1246)
C
Final Purification 1 Exit Airlock(1247)
C
Final Purification 2(1260)
C
2025
10
Final Purification 2 Gowning(1262)
C
Final Purification 2 Material Airlock(1264)
C
Final Purification 2 Jan/Tools(1265)
C
Final Purification 2 Control Room(1266)
C
Final Purification 2 Material Airlock(1267)
C
Final Purification 1 and 2 Gowning(1241)
D
442
2
Final Purification 1 Material Airlock(1243)
D
Final Purification 2 Material Airlock(1263) r
D
Final Purification 1 Exit Airlock(1248) V—
D
144
1
Final Purification 2 Exit Airlock(1268)
D
Return Corridor(1024, 1230, 1072, 1031)
E
2597
8
Supply Corridor(1021) (74
E
2674
8
Corridor and Closets/Airlocks Supply Material Airlock (1022, 1071, 1120,
1140, 1150)
E
966
3
Stair Wells(1003, 1004, 1005, 1006, 1007
E
216 each
1
Supply Corridor Storage Closets(1160, 1170, 1180, 1190, 1200)
E
743
2
s
II w:.
,,
_
.-4
="Ildr
®
--
r�
T.
--
1
1
I
f''�
m---I--`
-r r i
I O+ r
r
-E, ,I,
a _iglu®
�i•
i
�y
1
L�
""
....
ia._'
�e li
1 , III
0:°yii_-iai
___I�_
1,�.:_;
- I'
—
�.
0
,I�
r__�
���
,
I
I
I Ili
1`-'�
_X
!mil—ITf--
' �
,ICI
_-_
*:� A,,,,i
—
� ,
_
-®
u-7.
I' tf
_-- {__—
I�
I i
{—_—_—__—_--}_—_— —_-
'
_—{—_—_—
I
■ un.a zmeo
Print Date(UTC): 14-Dec-2021 22:12:36
Page 28 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix D: Bulk 2nd Floor Zones & Square Footage
Room Name
Zone
Square ft.
# of mops
Virus Seed Production Lab(2300)
C
864
4
Virus Seed Production Lab Gowning(2302)
C
Virus Seed Production Lab Material Airlock(2304)
C
Virus Seed Production Lab Exit Airlock(2305)
C
Seed Virus Cell Expansion Lab(2310)
C
573
3
Seed Virus Cell Expansion Lab Exit Airlock(2315)
C
Seed Virus Cell Expansion Lab Material Airlock(2314)
C
Seed Virus Cell Expansion Lab Gowning(2312)
C
Virus Adaptation/Analysis Lab(2330)
C
623
3
Virus Adaptation/Analysis Lab Gowning(2332)
C
Virus Adaptation/Analysis Lab Exit Airlock(2333)
C
Virus Prep Lab(2340)
C
413
3
Virus Prep Lab Exit Airlock(2343)
C
Virus Prep Lab Gowning(2342)
C
Virus Seed Production and Expansion Labs and Airlocks (2303, 2301,
2313, 2331)
D
340
2
Seed Virus Cell Expansion Exit Airlock(2310, 2312, 2314, 2315, 2316)
D
573
3
Virus AdaptationLab (2330, 2332, 2343)
D
623
3
Virus Prep Lab(2340, 2342, 2343)
D
413
2
Infectious In -Process Test Lab(2360)
D
842
4
Infectious In -Process Test Lab Gowning(2361)
D
Clean Equipment Prep(2154, 2151)
D
967
4
Clean Equipment Staging(2156)
D
448
2
Clean Equipment Staging Gowning(21_ 11
D
Clean Equipment Staging Material Airlock(2158)
D
Infectious Purification Line 1(2160, 2161, 2162, 2165, 2166)
D
2462
12
Infectious Purification Line 2(2190, 2191, 2192, 2195, 2196)
D
2462
12
Column Packing (2180, 2181, 2182)
D
444
2
Women's Return and Supply Locker(2050, 2051, 2056)
E
1362
6
Supply Corridor(2021, 2120, 2110)
E
3547
15
Supply Corridor(2023)
E
2858
12
Supply Corridor(2022, 2380, 2370, 2350, 2040)
E
2026
9
Return Corridor(2024, 2400, 2051, 2060, 2101)
E
2106
9
Infectious Return(2025, 2026, 2224, 2174, 2175, 2225)
E
1900
8
Infectious Return Material Airlock(2027, 2028, 2270, 2321, 2240)
E
1478
6
Infectious Return Gowning(2280, 2290)
E
447
2
Stairwells(2003, 2004, 2005, 2006, 2007)
E
216 each
1
Dirty Equipment Staging(2140, 2150)
E
1268
5
Decon Autoclave Unload(2250)
E
365
2
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix D: Bulk 2nd Floor Zones & Square Footage
Print Date(UTC): 14-Dec-2021 22:12:36
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix E: Warehouse 1st Floor Zones & Square Footage
Room Name vvvb
Zone
Square ft.
# of mops
Sampling Room(6114)
C
978
5
Material Airlock(6112)
C
G/DG(6110)
C
Airlock(6111)
D*
*Airlock will be cleaned as a Zone C area, on the same frequency as the other rooms listed in
the table above. This area is adjacent to a Zone 4 area.
FILL FINISH/PACKAGE
tL11
--
WoirE
1.5BI_Ir
AMBER
511, I—.
.25T
2 Ci S lurr
4141
+30'C STABILITY
LC.A I ILL C
CROSS
GPI J
E
241E P
PLE FCJ :. NLYMC
MEDIA ATIEN
❑C ❑�
EEE:
BEER
ELEVATOR
L; F p, F IMClimomiN
&IC5
F1RE RISER !�
Rely, IIIIIIII 1 61iR 1
LIIII •
Zone D
Zone C
1 1 I 1 1 1 I 1 I 1 1 I 1 1 1 1 I
1.
I T I 1 I 1 1 i I I I I I I
A 4 I ff GNP STCRME
014
1 I I I I !III
GMP SiII9µ.HC
iARre
s E 6+ 1
TR I.ER
81.4
HALM OLL3
MIIG
r7CAI-FLAd1AELE
_ 1AIAF]➢(]L5_
Print Date(UTC): 14-Dec-2021 22:12:36
Page 31 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix F: Fill Finish Building 04, 1st Floor Zones & Square Footage
Room Name
Zone
Square ft.
# of mops
Weigh and Dispense(1040)
C
695
4
Weigh and Dispense Gowning(1039)
C
Weigh and Dispense Material Airlock(1044)
C
Adjuvant Process(1035)
C
986
5
Adjuvant Material Airlock(1032)
C
Adjuvant Gowning(1033)
C
Formulation Process(1028)
C
999
5
Formulation Material Airlock(1026)
C
Formulation Gowning(1025)
C
Gowning(1041)
D
236
1
Production Offices(1043)
D
580
3
Huddle Room(1042)
D
Syringe Filling(1029)
D
1826
9
Cold Storage(1031)
D
321
2
Corridor(1004, 1022, 1014, 1038)
D
3402
14
Parts Wash and COP(1016, 1017)
D
1495
8
Parts Prep(1018)
D
1263
7
Clean Parts Staging(1023, 1024)
D
994
5
Packaging Hall (1005, 1013, 1021)
E
5820
24
Tub Accumulation(1046)
E
839
3
Material Airlock(1012)
E
380
2
Syringe Staging(1037)
E
915
4
■ Zone E ❑ Zone D ❑ Zone C
Print Date(UTC): 14-Dec-2021 22:12:36
Page 32 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix G: QC Lab 2nd Floor Zones & Square Footage
Room Name/Number
Zone
Square ft.
# of mops
Gown/Degown to Sterility Test 2 Room (2350)
B
143
1
Sterility Test 2 Room (2348)
B
Gown/Degown to Sterility Test 1 (2340, 2342, 2344, 2346, 2352)
D
896
4
Sterility Test 1 Room (2358)
D
Sterility Incubator Room (2364)
D
Sterility Autoclave Staging Room (2362)
D
Print Date(UTC): 14-Dec-2021 22:12:36
Page 33 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix H: Fill Finish SSF Building 09, 1st Floor Zones C, D, and E and Square
Footage
Room Name/Number
Zone
Square ft.
# of mops
Gown Room, 1309
C
212
2
Degown Room, 1310
C
Material Airlock In Room, 1311
C
114
1
Material Airlock Out, Room, 1312
C
Formulation Room, 1315
C
359
2
Formulation Room, 1316
C
384
2
Laboratory Room, 1317
C
91
1
Corridor, 1313/1314
C
279
2
Parts Staging Room, 1321
C
145
1
Degown Room, 1325
C
114
1
Material Airlock Room, 1333
C
Airlock Room, 1308
D
167
1
Material Airlock Room, 1336
D
Material Airlock, Room 1301
D
Office, Room1302
D
160
1
Corridor, 1303
D
634
4
Corridor, 1322
D
461
3
Finished Product Inspection, Room 1300
E
263
2
Labeling/Packaging, Room 1304
E
1029
6
Material Staging, Room 1338
E
230
2
Material Staging/Storage, Room 12 7
E
223
2
Print Date(UTC): 14-Dec-2021 22:12:36
Page 34 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
wSTIBIILE _7.5 PR
®'
Appendix H: Small Scale Filling Drawing Reference
BBB KhrliCI
- BSI.-3/NON-GNP BIOCONTNNMENT BOUNDARY
- BSI.-2/CMP BIOCONTNNMENT BOUNDARY
- BEL-2/NON-GMP BIOCONTNNMENT BOUNDARY
MR FLOW DIRECTION
ROOM PRESSURIZATION
NOTE 1 - ZONE C UAF
NOTE 2 - ZONE B UAF
NOTE 3 - ZONE A UAF
0
a
Page 35 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix I: Fill Finish Building 05, 1st Floor Zones C, D, and E and Square Footage
Room Name/Number
Zone
Square ft.
# of mops
Material Airlock (MAL), 1607
C
173
1
Gown In, 1608
C
163
1
Supply Corridor, 1609
C
1631
7
Clean Parts, 1506
C
391
2
Vestibule, 1502
C
93
2
Parts Prep, 1505
C
391
2
Parts Wash, 1501
C
311
2
Fill Line, 1301
C
1102
5
Storage, 1612
C
227
1
IPT lab, 1205
C
160
1
Formulation Vestibule, 1201
C
259
2
WIP Cold Storage, 1203
C
251
2
Formulation Suite 2, 1202
C
540
3
Formulation Suite 3, 1204
-
566
3
Storage, 1613
C
76
1
Exit Airlock, 1610
C
89
1
Women Exit A/L, 1604
D
95
1
Men Exit A/L, 1605
D
93
1
Women Gown In, 1603
D
108
1
Men Gown In, 1606
D
128
1
New Connect, 1602
D
428
2
Airlock, 1611
E
167
1
Packaging Vestibule, 1408
E
264
2
Packaging Corridor, 1407
Syringe Staging, 1403
General Packaging, 1402
E
29171
117
Inspection Room, 1615
E
236
1
Women Locker, 1111
E
391
2
Men Locker, 1105
E
360
2
Print Date(UTC): 14-Dec-2021 22:12:36
Page 36 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

rieciirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix I: Fill Finish Building 05, Zone Classification Diagram
LEGEND
• ZONE E.
EIZONE D
EZONE C
Print Date(UTC): 14-Dec-2021 22:12:36
Page 37 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segir us
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix J: Overlapping Disinfection Method
Print Date(UTC): 14-Dec-2021 22:12:36
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Document Number: SOP-000081283
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Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix K: Method for Moving the Sartorius Portable Scales
• Adjust the porting wheels as described below:
• Remove the drive -on ramp from the front of the scale.
• Make sure there is no load on the platform.
• Make sure to observe the safety instructions.
• Keep the drive -on ramp with the floor scale when moved.
Figure 1
• Remove the threaded caps f--)m + ie four threaded fasteners.
Figure 2
Print Date(UTC): 14-Dec-2021 22:12:36
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Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segir us
A CSL COMPANY
Title: Cleaning and Disinfection of Controlled Areas
Appendix K: Method for Moving the Sartorius Portable Scales
• Locate and attach the two hand cranks to the two threaded fasteners at the front of scale.
• Turn the cranks clockwise to lower the transport rollers.
• Repeat this procedure for the two rear rollers.
Note: Replace caps after transport rollers are lowered.
Fic:.re
• The scale can now be moved to clean the floor area under the scale.
Figure 4
Print Date(UTC): 14-Dec-2021 22:12:36
Notes:
• Ensure there is no load on the platform when moving it.
• Return the scale to its original location leaving the transport wheels engaged.
• A Manufacturing Associate will setup the scale for use and reinstall the drive -on ramp.
Page 40 of 43
Document Number: SOP-000081283
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Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Zone D
Appendix L: Square Footage Examples
STERILITY
TEST #2
1.2348
ZONE
143 SOFT
r
ZONE P,
L AIR LOCK
1.2340
ZONE
250 5
STERILITY
TEST #2
1.2348
i
LP\E 2
250 SQFI
STERILITY
TEST #1
1.2358
ZONE 3
178 SQF1
DECN
STAGI
1.2362
.2334
ZONE 4
250 SOP
GOV
1.23
ZONE 4
EQUIP
1.2364
Print Date(UTC): 14-Dec-2021 22:12:36
Page 41 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix L: Square Footage Examples
MATE AL
1032
IE 4
ADJUV
1035
GOW
ECOW •.
1Q3�
• E 3
•,E
2 4-4 FT
ZONE 1
250 SOFT
1
Print Date(UTC): 14-Dec-2021 22:12:36
Page 42 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Appendix L: Square Footage Examples
w
< E
LC
m
o
SAMPLE
BOOTH
LAFA❑OVE
❑ E -:
7 :FT
SAMPLING.
6114
SS/EW
. IF
i-I
.E
OMIR
GOWN/
DEGOWN
lsi*O 611°
6]108
IHFNCH
E
.1112E
ZONE
',OFT
MAT1L AIRL
6112
6t1ZA
❑IIE '
AIRLOCK
6111 •
fi111A
Print Date(UTC): 14-Dec-2021 22:12:36
Page 43 of 43
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021

Segirus
Title: Cleaning and Disinfection of Controlled Areas
A CSL COMPANY
Electronic Signatures
User Name
Date
Justification
Austin, Christopher US/HSP
22-Nov-2021
I am providing Functional approval
21:28:36
Gomes, Avita US/HSP
24-Nov-2021
I am providing quality approval
14:18:20
Print Date(UTC): 14-Dec-2021 22:12:36
Document Number: SOP-000081283
Version: 34.0, CURRENT Confidential Effective Date (UTC): 07-Dec-2021