Kite Issued #:

Test Method TM-0068

Title: Active Viable Air Sampling Page 1 of 7

Batch file Name: N/A

1. Purpose
1.1. To describe active viable air monitoring method using Surface Air System (SAS) Super
180 & SAS Isolator Microbial Air Samplers
2. Scope
2.1. This test method applies to all active viable environmental monitoring at TCF03.
This is an electronically controlled document. User is responsible for verifying and using the effective version.

3. Test Principle
3.1. Air is aspirated at a fixed speed for a certain amount of time through a SAS head which
has a series of small holes of a special design, allowing air to flow in. The resulting
laminar air flow is directed onto the agar surface containing medium consistent with the
microbiological examination to be made. When the preset sampling cycle is completed,

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the plate is removed and incubated. After incubation, all visible colonies are counted,
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and this gives a direct quantitative estimate of the number of colony forming units in
the volume of air collected.
4. Reference Documents
4.1. SOP-00621, Operation of the SAS Super 180 and SAS Isolator Microbial Air Samplers
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4.2. SOP-00162, Environmental Monitoring Program
4.3. SOP-00215, Sample Chain of Custody
4.4. SOP-00254, Approved Disinfectant
4.5. WRK-00257, Taping of Media Plate Lids
5. Definitions
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5.1. N/A
6. Equipment/Materials
6.1. SAS Super 180 & SAS Isolator Microbial Air Samplers
6.2. Disposable Sampling Heads for SAS, KG00832
6.3. Stainless Steel Sampling heads
6.4. Tryptic Soy Agar (TSA) w/lecithin & P80 Contact Plates; KG00209
6.5. Sterile 70% IPA Wipers; KG00117
6.6. Sterile 70% Isopropanol Alcohol (IPA) spray bottle; KG00035
6.7. PeridoxRTU® 32 Oz Sterile, KG00123
6.8. STERI-PEROX® 6% Sterile Wipes, KG00460
6.9. Hydrogen Peroxide 6% Solution, Sterile, 16 oz, KG00461
6.10. Sterile cleanroom wipes
6.11. Alcohol-proof marker or pre-printed labels
6.12. Lab or cleanroom tape
7. Safety
7.1. Required personal protective equipment (PPE):
7.1.1. Gowning per area requirements.

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Kite Issued #:
Test Method TM-0068

Title: Active Viable Air Sampling Page 2 of 7

Batch file Name: N/A

7.1.2. Do NOT us this procedure in the presence of explosive gas.

7.1.3. Discard used disposable heads into a biohazardous bin.
8. Responsibilities
8.1. QC Microbiology:
8.1.1. Perform sampling per site specific EM SOPs
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8.1.2. Incubate and enumerate sample plates

8.2. Manufacturing:
8.2.1. Perform sampling as required by batch record
8.2.2. Submit sample plates to QC for incubation
9. Procedure

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P1. General Requirements
Step
1.
Action
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Prior to use for sampling, verify the calibration due date has not expired.
2. Only use media that has passed growth promotion, and is within expiry.
3. Inspect media plate for any defects (i.e. cracks, contamination, etc.) before use. Obtain a new
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plate if any defect is observed.
4. Disposable sterile SAS heads can be left on an SAS machine up to 7 days, and must be sanitized
prior to use per section P2. Using a sharpie, document the 1st day of use on the side of the
head.
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5. If at any time the top of the sampling head is touched, wipe disposable sampling head with
sterile 70% IPA and allow to dry before use.
Stainless Steel Sampling heads must be cleaned with any of the sporicidal agent (STERI-PEROX®
6% or PeridoxRTU®) listed in SOP-0382.
6. Before using the SAS ensure that the sample volume is set at 1000L. To set volume, refer to
SOP-00621.
7. Prior to use for sampling, verify the calibration due date has not expired.
8. Only use media that has passed growth promotion, and is within expiry.
9. Inspect media plate for any defects (i.e. cracks, contamination, etc.) before use. Obtain a new
plate if any defect is observed.
10. Disposable sterile SAS heads can be left on an SAS machine up to 7 days, and must be sanitized
prior to use per section P2. Using a sharpie, document the 1st day of use on the side of the
head.
11. If at any time the top of the sampling head is touched, wipe disposable sampling head with
sterile 70% IPA and allow to dry before use.
Stainless Steel Sampling heads must be cleaned with any of the sporicidal agent (STERI-PEROX®
6% or PeridoxRTU®) listed in SOP-0382.

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Kite Issued #:
Test Method TM-0068

Title: Active Viable Air Sampling Page 3 of 7

Batch file Name: N/A

P1. General Requirements

Step Action
12. Before using the SAS ensure that the sample volume is set at 1000L. To set volume, refer to
SOP-00621.
13. For isolator models, do not wrap the cord around the unit.
This is an electronically controlled document. User is responsible for verifying and using the effective version.

14. When sampling is complete, store the unit, plugged in, on its back in order to avoid the SAS
from being knocked into and falling.

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Figure 1: SAS (Surface Air System)
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P2. Sanitization of SAS Unit and Sampling Head

Step Action
Follow the steps below to sanitize SAS before use:
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1. Wipe the exterior of the SAS unit including the sample loading area using sterile 70% IPA wipe
or sterile wipe sprayed with sterile 70% IPA.
2. If using the SAS disposable sampling head, wipe the exterior and interior using a sterile 70%
IPA wipe or sterile wipe sprayed with sterile 70% IPA.

Prior to use of stainless steel sampling heads, wipe or spray both inside and outside of the
sampling head with sporicidal agent (STERI-PEROX® 6% or PeridoxRTU®).

Allow minimum disinfectant exposure time per SOP-0382.

Wipe the residual sporicidal agent with sterile 70% IPA.

3. The following steps should be performed in the ISO classification that the unit is to monitor.
 Confirm that the sampling head is connected if using the isolator model.
 Spray sterile 70% IPA approximately 30 cm from the head while the fan is running for
approximately 30 seconds.
 Allow IPA to dry prior to use for sampling.

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Kite Issued #:
Test Method TM-0068

Title: Active Viable Air Sampling Page 4 of 7

Batch file Name: N/A

P2. Sanitization of SAS Unit and Sampling Head

Step Action
This is an electronically controlled document. User is responsible for verifying and using the effective version.

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Figure 2: Sanitizing SAS
4. If… Then…
performing sampling in ISO 5 BSC per batch record Sanitize the sampling head inside the BSC
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(in-process monitoring) at beginning of each shift.
performing routine sampling using either the SAS Sanitize the sampling head prior to
Super 180 model or Isolator Microbial Air sampling per ISO area.
Samplers in ISO 5, ISO 7 and ISO 8 (QC Personnel)
5. NOTE: When possible, sampling should be done from higher classification to lower
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Classification.

For example:
ISO 5 → ISO 7 → ISO 8

If sampling in this manner is not possible use a new sampling head, or wipe the sampling head
using sterile 70% IPA wipes in-between each ISO classification.
P3. Sampling
Step Action
Follow the steps below for sampling:
1. Label the plate with sample identification (obtain from batch record for in-process EM and SOP-
00162 for routine), production lot # (if applicable) and test date.
2. If monitoring inside ISO 5 BSC, wipe the exterior of the labeled plate with an approved
disinfectant and transfer the plates inside the BSC. Ensure to not transfer any disinfectant
inside to the agar media.
3. Press the ON/OFF button at the bottom of the SAS machine. An automatic visual display will

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Kite Issued #:
Test Method TM-0068

Title: Active Viable Air Sampling Page 5 of 7

Batch file Name: N/A

P3. Sampling
Step Action
appear.
4. Aseptically unscrew the sampling head by handling only on the side. Do not touch the top part
of the SAS head.
This is an electronically controlled document. User is responsible for verifying and using the effective version.

NOTE: If inside the BSC, the SAS head can be placed on BSC work surface face down. If
monitoring ISO7 or ISO 8 areas, place the head face down on a sterile dry wipe.
Top of head

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tiv Face down
position
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Figure 3: SAS head

5.  Do not remove the lid of the contact plate. Place the contact plate inside the pins located on
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top of the SAS machine, and remove lid.

Figure 4: Place the contact plate inside the pins

 Avoid touching the edged of the agar. If the agar is compromised prior to starting the
sampling session, replace with a new contact plate.
 Contact plate must be placed agar side up.
 Contact plate lid can be placed on clean BSC work surface if in ISO 5 BSC or on a sterile dry
wipe if outside BSC.

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Kite Issued #:
Test Method TM-0068

Title: Active Viable Air Sampling Page 6 of 7

Batch file Name: N/A

P3. Sampling
Step Action
6. Aseptically screw the SAS head back onto the unit and push the START button
Allow for full sample cycle of 1000L to be taken
An audible beep will indicate sample completion
This is an electronically controlled document. User is responsible for verifying and using the effective version.

7. At the end of the sample cycle aseptically unscrew the SAS head, replace the contact plate lid
and remove the plate.
8. Tape each plate to ensure lid does not fall off during transport then tape the stack of plates
together.
9. Complete sample submission form and submit samples and test form to QC.

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P4. TCF03 Sample Receipt and Incubation
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Step Action
TCF03 QC Personnel performs the following activities
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1. Receive in-process samples per SOP-00215
NOTE: Sample receipt is not required for routine EM samples collected by QC Microbiology.
2. Incubate plates per SOP-00162
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10. Attachments
10.1. N/A

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Kite Issued #:
Test Method TM-0068

Title: Active Viable Air Sampling Page 7 of 7

Batch file Name: N/A

11. Revision History Summary

Originator Revision Summary of Changes
Y. Yang 0  New document.
 Transfer of test procedure from
SOP-0248-QC3 to test method
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format
A.Bhakta 1  Reference section updated to
include SOP-0382.
 Equipment/Material section
updated to include KG#.

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 Section P2 updated to add details
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and clarification for cleaning
Stainless Steel Sampling heads.
A. Satidkit 2  Additional instructions to clean
the SAS unit and its sample loading
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area and interior of the sampling
heads in section P2 in response to
AGILE-CAPA-00681.
 Added reference to WI-0353
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Gap in revision numbers is a result of the migration of documents from Document Locator into GVault
that occurred in December 2018. See PLAN-00020 “Kite Quality Plan for GVault Implementation” for
more details.
Originator Version Summary of Changes Rationale for Changes
A. Castaneda 5.0 1. Reference to MPR removed from 1. Reference to MPR removed from
the document and replaced with document to align with TCF03
batch record EBR transition
2. Remove repeated instructions in 2. Provide clarification for
sanitization section sanitization prior to sampling
3. Updated Revision history summary based on ISO classification
table format 3. Formatted to align with other
4. Document formatted Test Methods
4. Document reformatted to adapt
to TMP-00234

For Use Only By Employees and Other Authorized Persons

THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION - DO NOT REPRODUCE OR DISCLOSE TO OTHERS WITHOUT PRIOR WRITTEN APPROVAL.
Doc. Status Effective Document No. TM-0068
Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068
 Document No.: TM-0068 Document Version: 5 .0
Name: TM-0068 Active Viable Air Sampling
Document Type: Governance and Procedures
Document Subtype: Analytical Test Method
This is an electronically controlled document. User is responsible for verifying and using the effective version.

Classification:
Title: Active Viable Air Sampling

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Approved By | Verdict Capacity | Date Approved

Sandani Silva, QC Specialist

tiv Functional Approval
Approve 19-Nov-2019 18:01:01 GMT+0000
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Vaishali Shah, Assoc Director, Quality Control QA/Compliance Approval
Approve 19-Nov-2019 18:16:37 GMT+0000
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Doc. Status Effective Document No. TM-0068

Effective Date 12 Dec 2019 GVault Ver. No. 5.0
Date Printed 16 Jan 2020 Legacy Doc. No. TM-0068