Operation and Maintenance of Portable Microbial Sampler

Number: WI-00022 Version: 0.
3 Status: Draft
Operation and Maintenance of Portable Microbial Sampler
Operation and Maintenance of Portable
Document Name:
Microbial Sampler
Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:
TABLE OF CONTENTS
1 PURPOSE 2
2 SCOPE 2
3 REFERENCES AND RELATED DOCUMENTS 2
4 ROLES AND RESPONSIBILITIES 2
5 ENVIRONMENT, HEALTH AND SAFETY 3
6 EQUIPMENT, MATERIAL AND SOFTWARE 3
7 INSTRUCTIONS 3
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8 APPENDICES 8
9 REVISION HISTORY 12
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CONFIDENTIAL AND PROPRIETARY PAGE 1 OF 12

This copy of the document was retrieved from AbCellera's Veeva Vault by Vanessa Brady on 2024-11-15
Number: WI-00022 Version: 0.3 Status: Draft
Document Name:
Microbial Sampler
1 Purpose
1.1 To provide instruction for operation and maintenance of Portable Microbial Sampler.
2 Scope
2.1 This instruction is applicable to Portable Microbial Sampler used at AbCellera Biologics Inc.
2.2 The following manufacturer/model(s) are in scope of the instruction:

• MiniCapt Mobile Air Sampler
2.3 This instruction does not include maintenance or calibration activities that are performed by
a third-party service provider.
3 References and related documents

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3.1 External references and related documents
P/N 1000026096 MiniCapt Mobile User Manual

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USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments

USP <1117> Microbiological Best Practices
EU GMP Annex 1 Manufacture of Sterile Medicinal Products
ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments
3.2 Internal references and related documents
SOP-000X Environmental Monitoring in LabWare LIMS
WI-XXXX Operation and maintenance of Autoclave
4 Roles and Responsibilities

4.1 QC Analyst Responsibilities
• Ensure training on this instruction is completed before performing any relevant tasks.
• Initiate work requests within CMMS as required.
• Ensure all equipment/instruments are within calibration/maintenance due date (as per
CMMS).

Document Name:
Microbial Sampler
• Ensure aseptic technique is adhered to at all times when carrying out this procedure.
4.2 QC Manager/Designee Responsibilities
• Ensure that all personnel are trained on this instruction before performing any relevant
tasks.
4.3 Facilities & Engineering and Lab Equipment Responsibilities
• Support coordination of third-party service as required for routine non-routine
maintenance as applicable.
5 Environment, Health and Safety

5.1 Appropriate PPE must be worn at all times in the laboratories, refer to SOP-00051, Gowning
Procedure for the QC Laboratory and SOP-00055, Quality Control Laboratory Best
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Practices.
6 Equipment, Material and Software

6.1 MiniCapt Portable Microbial Sampler, P/N 790045-0050
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6.2 Air sampler head P/N 1000019036

6.3 TSA 90mm agar plate, Merck P/N 1466830120 or equivalent
6.4 SDA 90mm agar plate, Merck P/N 1460050120 or equivalent
6.5 70% IPA, Contec P/N 19200023 or equivalent
6.6 Fisherbrand lint-free wipes, P/N NT11212CBFB or equivalent
6.7 Sterile gloves
6.8 Labels/permanent marker
7 Instructions
7.1 Overview
7.1.1 Refer to Appendix 1 for an overview of the MiniCapt Mobile Portable Microbial Sampler
and Appendix 2 for User Capabilities.
7.1.2 The touchscreen is located at the top of the MiniCapt chassis and is backlit when the unit
is powered on. There are two LED lights located below the touchscreen:
• Sampling LED:

Document Name:
Microbial Sampler
o During sampling – LED is solid green

o Not sampling – LED is off
• Status LED:
o Powered on – LED is solid green
o Warning – LED flashes yellow
o Alarm – LED flashes red
7.1.3 Ensure the unit has sufficient battery charge for testing. The battery level is displayed on
the home screen when the unit is powered on, refer to Appendix 1, figure B. Battery
charge is checked in real-time during sampling. If the battery charge drops outside 10%
tolerance the system will provide a warning but will continue to sample. If ignored, the
sample will be terminated, and the unit will shut off.
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7.1.4 Confirm sampling locations using LabWare LIMS, as per WI-XXX Environmental
Monitoring in LabWare LIMS. Document sampling activities as per WI-XXX
Environmental Monitoring in LabWare LIMS accordingly. In the event LIMS is
unavailable, applicable worksheets must be obtained.
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7.2 Operation
7.2.1 Viable air sampling:
7.2.1.1 Spray gloved hands with 70% IPA and place an unopened, labelled agar plate on
the plate holder, ensuring it is secure, refer to Appendix 1, figure C.
7.2.1.2 Ensure the plate is installed with respect to the circles etched into the plate holder,
as shown in figure 1 below.
Figure 1: Agar plate centered using etched circles on plate holder

Document Name:
Microbial Sampler
7.2.1.3 Remove the air sampler head form the autoclave pouch by carefully tearing the seal.
Handle the sampler head along the outside edges, ensuring the inside of the head
isn’t handled. Ensure the operators hands do not pass over the sampling head.
7.2.1.4 Remove the lid of the agar plate and place the sampling head onto the unit. Place
the agar lid face down on a disinfected surface, near the air sampler. Avoid
exposing the interior of the agar lid to potential contamination.
7.2.1.5 Twist the sampling head clockwise to tighten into place.
7.2.1.6 Turn the MiniCapt on by pressing the power button located on the right side of the
unit base. Log in to the unit using unique login credentials, if required.
7.2.1.7 Wheen the Home Screen appears, navigate to the Features menu, as shown in
Figure 2 below.
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Figure 2: Home Screen displaying the Features menu
7.2.1.8 Confirm the following parameters prior to starting the run: Sample volume = 1000L
7.2.1.9 To start the run, select the Start Sampling button. Allow the sample
to run to completion.
7.2.1.10 After the sample has run to completion, spray gloved hands with 70% IPA and allow
to air dry. Aseptically remove the air sampler head by turning counter-clockwise.
Store the air sampler head on a disinfected surface or saturated IPA wipe, ensuring
the exterior of the head is not exposed to the environment.
7.2.1.11 Aseptically replace the lid of the agar plate, ensuring operators hands do not pass
over the exposed plate. Remove the plate from the MiniCapt by handling the edges

Document Name:
Microbial Sampler
of the plate. Care should be taken not to touch the inside of the lid or agar plate.
Seal the plate with tape and place in a suitable sample collection trolley.
7.2.1.12 For sample handling and incubation, refer to SOP-00057 Environmental Monitoring
Program.
7.2.1.13 If another sample must be taken, wipe down the sampling head with a lint-free wipe
saturated with 70% IPA. Allow IPA to evaporate before taking the next sample.
Repeat this process prior to each sample.
7.2.1.14 When sampling activities are completed, sterilize the sampling heads as per section
X of this work instruction.
7.3 Data Export

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7.3.1 Data from the MiniCapt must be exported to the GxP server by QC periodically.
7.3.2 Insert the external USB drive into the USB port located at the front of the MiniCapt base,
refer to Appendix 1, figure A.
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7.3.3 Open the Features menu as per section 7.2.1.7. of this document and click Export
screen.
7.3.4 Select the Setup icon.
7.3.5 Select the Export icon.
7.3.6 Select the recipes checkbox.
7.3.7 Select the Export Now button to display the USB FLASH DRIVE ‘Hard Disk’
screen.
7.3.8 Select the File Name field to display the keyboard. Enter the name of the exported file
as per appropriate naming convention i.e. YYYY-MM-DD_username.
7.3.9 Select the Done button.
7.3.10 Select the Export File button.

Document Name:
Microbial Sampler
7.3.11 The ‘Export Successful’ message will appear on the screen. The data items selected are
now exported to the external USB Drive.
7.3.12 Select the green checkmark button to clear the message.
7.4 Maintenance
7.4.1 Annual preventative maintenance is performed by the MiniCapt vendor.
7.4.2 In the event ad hoc maintenance is required, raise a work order in CMMS as per WI-XXXX.
7.4.2.1 Cleaning of the MiniCapt Sampler Heads

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7.4.2.1.1 Prior to sterilization, clean the sampler head with lint-free wipe saturated with 70% IPA.
7.4.2.1.2 To avoid discoloration, allow IPA residue to completely evaporate prior to sterilization.
7.4.2.1.3 Seal the sampler head in an autoclave pouch, and sterilize as per WI-00014, Operation and
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Maintenance of Laboratory Autoclaves.
7.4.2.2 Cleaning of the exterior unit

7.4.2.2.1 Prior to cleaning the unit, disconnect from power source if applicable.
7.4.2.2.2 Clean the exterior housing of the MiniCapt unit using a lint-free wipe saturated with 70% IPA.
7.4.2.2.3 Exterior cleaning of the unit should be carried out if the air sampler is being transferred from
a lower grade space to a higher grade space i.e. from a Grade D area to a Grade C area,
after any known contamination has occurred, and at the end of a sampling session.

Document Name:
Microbial Sampler
8 Appendices
List of appendices:
8.1 Appendix 1 – MiniCapt unit overview
8.2 Appendix 2 – User Capabilities
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Document Name:
Microbial Sampler
8.1 Appendix 1 – MiniCapt Unit Overview
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Figure A: MiniCapt Mobile Microbial Air Sampler
Figure B: Home Screen display

Document Name:
Microbial Sampler
8.1. Appendix 1: MiniCapt Unit Overview
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Figure C: MiniCapt unit showing sampler head and plate holder
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Figure D: Power button and power connector located on the right side of the unit base

Document Name:
Microbial Sampler
8.2. Appendix 2: User Capabilities
Function Administrator Supervisor Operator
Edit Users
Upload Users
Download Users
Lock/Unlock Instrument
Add/Edit Alarm Comments
Edit Time and Date

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Edit Network
Edit Units of Measurement

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Import Data
Export Data
Modify Sound
See System Status
Edit Queue Settings
Edit Calibration Notifications
Set Compressed Gas Pressure
Update Software
Choose Language
Calibrate Screen
About Info (Software info, etc.)
Reset Factory Defaults
Yes No

Document Name:
Microbial Sampler
9 Revision history
Change ID number Version Description
N/A 1.0 Initial release.
Note: Revision history captures only the five most recent revisions of the document.
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Number: WI-00022 Version: 0.

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

3 REFERENCES AND RELATED DOCUMENTS 2

4 ROLES AND RESPONSIBILITIES 2

5 ENVIRONMENT, HEALTH AND SAFETY 3

6 EQUIPMENT, MATERIAL AND SOFTWARE 3

CONFIDENTIAL AND PROPRIETARY PAGE 1 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

2.2 The following manufacturer/model(s) are in scope of the instruction:

3 References and related documents

P/N 1000026096 MiniCapt Mobile User Manual

USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments

3.2 Internal references and related documents

SOP-000X Environmental Monitoring in LabWare LIMS

WI-XXXX Operation and maintenance of Autoclave

4 Roles and Responsibilities

CONFIDENTIAL AND PROPRIETARY PAGE 2 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

5 Environment, Health and Safety

6 Equipment, Material and Software

6.2 Air sampler head P/N 1000019036

CONFIDENTIAL AND PROPRIETARY PAGE 3 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

o During sampling – LED is solid green

7.2.1 Viable air sampling:

Figure 1: Agar plate centered using etched circles on plate holder

CONFIDENTIAL AND PROPRIETARY PAGE 4 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

Figure 2: Home Screen displaying the Features menu

CONFIDENTIAL AND PROPRIETARY PAGE 5 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

7.3 Data Export

7.3.4 Select the Setup icon.

7.3.5 Select the Export icon.

7.3.6 Select the recipes checkbox.

7.3.9 Select the Done button.

7.3.10 Select the Export File button.

CONFIDENTIAL AND PROPRIETARY PAGE 6 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

7.3.12 Select the green checkmark button to clear the message.

7.4.2.1 Cleaning of the MiniCapt Sampler Heads

Maintenance of Laboratory Autoclaves.

7.4.2.2 Cleaning of the exterior unit

CONFIDENTIAL AND PROPRIETARY PAGE 7 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

8.1 Appendix 1 – MiniCapt unit overview

8.2 Appendix 2 – User Capabilities

CONFIDENTIAL AND PROPRIETARY PAGE 8 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

8.1 Appendix 1 – MiniCapt Unit Overview

Figure A: MiniCapt Mobile Microbial Air Sampler

Figure B: Home Screen display

CONFIDENTIAL AND PROPRIETARY PAGE 9 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

8.1. Appendix 1: MiniCapt Unit Overview

CONFIDENTIAL AND PROPRIETARY PAGE 10 OF 12

Document Number: WI-00022 Version: 0.3 Status: Draft Effective Date:

8.2. Appendix 2: User Capabilities

Function Administrator Supervisor Operator

Add/Edit Alarm Comments