MicroBio MBx

Bioaerosol Sampler
IQ / OQ / PQ

Equipment Serial Number INSERT DEVICE SERIAL NUMBER HERE

Prepared for INSERT END USER NAME HERE

INSERT END USER ADDRESS HERE

Contact INSERT END USER CONTACT NAME HERE

INSERT END USER EMAIL ADDRESS HERE
INSERT END USER TELEPHONE NUMBER HERE

Document Reference THIS PART TO BE COMPLETED BY END USER

All items shown in red text require editing

before publication.
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
Table of Contents
IQ / OQ / PQ Documentation...............................................................................................3
Document Issue............................................................................................................................ 3
Distribution................................................................................................................................... 3
Abbreviations................................................................................................................................ 3
References................................................................................................................................... 3
Introduction................................................................................................................................... 4
Document Scope.......................................................................................................................... 4
Responsibilities............................................................................................................................. 4
General Equipment Description....................................................................................................4

Installation Qualification (IQ)..............................................................................................5

IQ - Equipment Identification........................................................................................................ 5
IQ - Equipment Specification........................................................................................................ 6
IQ - Equipment Delivery................................................................................................................7
IQ – Summary Report................................................................................................................... 8

Operational Qualification (OQ)...........................................................................................9

OQ - Safety.................................................................................................................................. 9
OQ – Pre-Run Checks................................................................................................................ 10
OQ – Functional Tests................................................................................................................ 11
OQ – Training............................................................................................................................. 12
OQ – Equipment Calibration.......................................................................................................13
OQ – Operational Validation.......................................................................................................13
OQ – Summary Report............................................................................................................... 14

Performance Qualification (PQ).......................................................................................15

PQ – Trigger Factors.................................................................................................................. 15
PQ – Recalibration..................................................................................................................... 15
PQ – Functional Tests................................................................................................................ 16
PQ – Routine Maintenance.........................................................................................................17
PQ – Fault Rectification.............................................................................................................. 18
PQ – Summary Report............................................................................................................... 19

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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IQ / OQ / PQ Documentation

Document Issue

Issue Description Date Revision By Approved By

Insert Document
1 First Issue Creation Date Insert Name Here Insert Name Here
Here

Distribution

Recipient Company Contact Number

Insert End User Name

Insert Company Name Here Insert Number Here
Here

Abbreviations

IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification

References

A-00xxx MicroBio MBx Bioaerosol Sampler Operating Manual, by Cantium Scientific Limited
(supplied with equipment)

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
3
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
Introduction

This document describes the IQ / OQ / PQ for use with the MicroBio MBx Bioaerosol Sampler manufactured
by Cantium Scientific Limited, Dartford, Kent, United Kingdom. Various procedures and forms are detailed
within this document.

Document Scope

This document relates only to the MicroBio MBx Bioaerosol Sampler, serial number (Insert Device Number
Here).

The procedures in this document will ensure the MicroBio MBx Bioaerosol Sampler is performing as intended
and as supplied to (Insert End User Name Here).

Detailed operational instructions and how to analyse results obtained from samples are contained within the
operating manual for the equipment.

Responsibilities

(Insert distributor name here) has produced the first issue of this document for use by (Insert End User
Name Here).

(Insert End User Name Here) is responsible for the implementation and maintenance of this document in
accordance with their own procedures. Cantium Scientific Limited cannot assume responsibility for the
implementation, operation and continued use of this document or the equipment.

General Equipment Description

The MicroBio MBx Bioaerosol Sampler is one of the most economical samplers in the world for sampling
bioaerosols. They have been fully validated by the UK Department of Trade and Industry Validation of
Analytical Methods Programme to meet the standards required for a reference bioaerosol sampler.

The sampler collects bioaerosols by drawing a stream of air at a constant flow rate of 100/180* (* delete as
appropriate) litres per minute through a series of small holes in a metal head. The air stream then impinges
onto a sterile culture medium in a 55 mm contact plate or 90 mm Petri dish. After exposure to the air stream
of a given volume, the agar plate is removed and incubated. The numbers of colonies which develop are
counted enabling a calculation to be made of the concentration of bioaerosols in the air (CFU/m3 - colony
forming units per cubic metre).

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE

Installation Qualification (IQ)

IQ - Equipment Identification

Equipment Name MicroBio MBx Bioaerosol Sampler

Equipment Model Number Insert Model Number Here

Equipment Serial Number Insert Device Serial Number Here

Cantium Scientific Limited

Clarendon Gardens
Dartford
Kent
Manufacturer DA2 6EY
United Kingdom

+44 (0) 1322 252000

sales@cantiumscientific.com
Insert Distributor’s Name Here
Insert Distributor’s Address Here

Equipment Distributor

Insert Distributor’s Contact Number Here

Insert Distributor’s Email Address Here
Insert Distributor’s Name Here
Insert Distributor’s Address Here

Service Provider

Insert Distributor’s Contact Number Here

Insert Distributor’s Email Address Here
Equipment condition upon receipt New / Used / Refurbished* * Delete as appropriate
Date Received
Installation / Storage Location
Asset Number
IQ - Equipment Specification

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
MBx Kit Part Number Insert Kit Part Number Here

Flow Rate 100/180* l/min (* delete as appropriate)

Sample Volume Insert details depending on model

Sampling Volume Capacity Insert details depending on model

Other Features Insert details depending on model

Weight (including charger and carry case) x.x kg

Dimensions Insert details depending on model

4 x AA cells Alkaline or NiMh

Power
6V at xxxmA (maximum)

Noise Level Insert details depending on model

Environmental Operating Range -10 to 40℃ up to 90% RH

Sampling Plate Capacity Insert details depending on model

Sampling Head Insert details depending on model

* Based upon random volume samples at varying intervals until low battery warning given.  These tests were
done on units fitted with new and fully charged Ansmann max-e 2500mAHr NiMh cells.  Actual battery life
may vary due to volume taken per sample, interval between samples, age of cells and other environmental
effects such as humidity and temperature.

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
IQ - Equipment Delivery

Carefully unpackage the equipment and inspect to ensure all kit contents are present and undamaged.

Kit contents Present Missing Damaged

MicroBio MBx Bioaerosol Sampler   

XXX x X.X mm Stainless Steel Sampling Head (in sealed bag)   
Mini tripod (delete row if appropriate, MB2 models only)   
Ansmann battery charger (state what plug is fitted)   
4 x AA NiMh rechargeable cells   
Alternate charger plugs (state other plugs supplied)   
Charger car power lead   
External DC power supply [OPTIONAL]   
Plastic container with 55 mm contact springs   
Replacement head seal 0-ring (in pink bag) (delete row if not MB2)   
2 mm Hex key (in pink bag)   
Operating manual and Ansmann charger instructions supplied in
clear document wallet   

Calibration certificate (check date range valid)   

If any items are damaged or missing, please contact the distributor or manufacturer.

Comments:

Corrective action taken:

Distributor / Manufacturer informed:

Delete as appropriate

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
IQ – Summary Report

ASSESSMENT OF INSTALLATION QUALIFICATION

Serial number Insert Device Serial Number Here

Model MicroBio MBx Bioaerosol Sampler

Manufacturer Cantium Scientific Limited

Calibration certificate number Insert Calibration Certificate Number Here

Calibration valid to Insert Date Here

Deviations Operational Impact Acceptance Justification

Successful completion of the preceding checks indicates the equipment has passed the
Installation Qualification procedure and may now proceed to Operational Qualification.

Signature Print Name Date

IQ Completion

Deviations Approved

IQ Approved

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE

Operational Qualification (OQ)

OQ - Safety

The MicroBio MBx Bioaerosol Sampler conforms to regulatory and safety standards as detailed below.

Electromagnetic Compatibility (EMC) Directive 89/336/EEC repealed by 2004/108/EC to the following

standard:

EN 61326-1 Scientific, Test and Measurement Equipment

Referencing:

EN 55011 / CISPR11 Emissions for Industrial, Scientific and Medical Equipment

EN 61000-4-2 Immunity to Electrostatic Discharge

EN 61000-4-3 Radiated Immunity

Restriction of the Use of Certain Hazardous Substances (RoHS) in Electrical and Electronic Equipment
(EEE) Directive (2011/65/EU)

Electrical Safety
The MicroBio MBx Bioaerosol Sampler is a portable battery powered device. However, the battery
charger is mains electricity powered and should be inspected for electrical safety in accordance with local
industry and national requirements. The frequency will be in accordance with local requirements.

Scheduled Adherence
Routine Task Refer to Frequency
PASS FAIL
Electrical safety testing and inspection of
Ansmann battery charger
 
Comments:

If the above checks all pass, the equipment can be returned to use.

Checked By Signature Date

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
OQ – Pre-Run Checks

Step Pre-Run Check Refer to Acceptance Criteria PASS DISCREPANCY

No damage should
1 Inspect kit for damage -
be present  

Ensure device Calibration date Certificate has not

2
calibration is valid label on equipment expired  
Charger has
Ansmann charger
3 Fully charged AA cells
instructions
completed charging  
cycle

Sampler body cleaned Follow guidance in

4
with suitable wipes
Operating Manual
operating manual  
Plate holding springs
Follow guidance in
5 are correct for media Operating Manual
operating manual  
plates to be used

Insert battery cells into

6
MBx sampler
Operating Manual -  
If sampler reports
7 Switch on equipment Operating Manual low battery, repeat  
from step 3

State the sampling Follow guidance in

8
head type supplied
Operating Manual
operating manual  
Carry case is cleaned
Follow guidance in
9 and suitable for Operating Manual
operating manual  
location

Comments (include description of any failures or discrepancies):

Checked By Signature Date

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
OQ – Functional Tests

Step Functional Test Refer to Acceptance Criteria PASS FAIL

Display illuminates and shows

1 Equipment powers up Operating Manual device name/volume* (* delete  
as appropriate for MB2/MB1)

2 Battery level OK Operating Manual Display will show ‘Battery OK’  

Take a test sample 100/180* (* delete as
3 without plate or head Operating Manual appropriate) litres sampled in 1  
fitted minute

Comments (include description of any failures or discrepancies):

If the above checks all pass, the sampler is ready to use, following instructions in the
MBx Bioaerosol Sampler Operating Manual by trained operatives.

Checked By Signature Date

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
OQ – Training

Operating Practical
Trained Operators Authorised Signature Approval Date
Manual Read Training

 
 
 
 
 
 
Comments:

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
OQ – Equipment Calibration

Annual calibration of the equipment must be performed by the manufacturer or appointed service provider. A
certificate will be issued with the equipment upon calibration and a new calibration due date label will be
placed on the equipment.

The equipment is calibrated on day of shipment from the factory using equipment traceable to national
standards. A certificate is provided with each new device and states calibration date, due date,
measurement results and details of the equipment used for calibration, with reference to calibration
equipment calibration certificates.

See PQ – Recalibration for full procedure details.

OQ – Operational Validation

Regular calibration by the user is not usually required, however, regular checks may optionally be performed
by users, using the MicroBio Validation Kit (Cantium Scientific Limited part no. A-00058), to indicate the MBx
air flow is functioning correctly.

Validation Kit
Validation Date
serial number
Performed By

Validation step Refer to Acceptance criteria PASS FAIL

As per check required in
Assemble validation kit Validation kit manual validation kit operating  
manual

Flow measured steady

Flow rate confirmation Validation kit manual
at 100 litres / minute  
Comments:

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
13
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
OQ – Summary Report

ASSESSMENT OF OPERATIONAL QUALIFICATION

Serial number Insert Device Serial Number Here

Model Bio MBx Bioaerosol Sampler

Manufacturer Cantium Scientific Limited

Calibration certificate number Insert Calibration Certificate Number Here

Calibration valid to Insert Date Here

Date released for use

Deviations Operational Impact Acceptance Justification

Successful completion of the preceding checks indicates the equipment has passed the
Operational Qualification procedure and may now be released for operational use.

Signature Print Name Date

OQ Completion

Deviations Approved

OQ Approved

Performance Qualification (PQ)

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
PQ – Trigger Factors

Recalibration Routine Maintenance Functional Tests

  

PQ – Recalibration

Current certificate number

Recalibration step Refer to Frequency Not Done PASS FAIL

Return to manufacturer /
Operating Manual Annually   
service provider

Service provider used Date submitted New certificate number PASS FAIL

Insert Distributor Name 

 
Cantium Scientific Ltd 
Comments:

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
PQ – Functional Tests

NOT
Step Functional Test Refer to Acceptance Criteria PASS FAIL
DONE
Display illuminates and
shows device
1 Equipment powers up Operating Manual name/volume* (*   
delete as appropriate
for MB2/MB1)

Display will show

2 Battery level OK Operating Manual
‘Battery OK’   
Take a test sample 100/180* (* delete as
3 without plate or head Operating Manual appropriate) litres   
fitted sampled in 1 minute

Comments (include description of any failures or reasons for test not being undertaken):

If the above checks all pass, the sampler is ready to use, following instructions in the
MBx Bioaerosol Sampler Operating Manual by trained operatives.

Checked By Signature Date

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
PQ – Routine Maintenance

Routine Maintenance
The MicroBio MBx Bioaerosol Sampler is designed to require minimal maintenance and servicing. If any
faults occur the service provider or manufacturer should be contacted.
The frequency of routine maintenance tasks should be recorded below.

Frequenc Scheduled Adherence

Routine Task Refer to
y OK Discrepancy

Clean MBx and carry case using

sterilising wipes or within HPV chamber
Operating Manual  

Ensure plate holding springs are secure

and functional
Operating Manual  

Inspect sampling head seal for wear and

replace if required
 
Comments:

Electrical Safety
The MicroBio MBx Bioaerosol Sampler is a portable battery powered device. However, the battery
charger is mains electricity powered and should be inspected for electrical safety in accordance with local
industry and national requirements. The frequency will be in accordance with local requirements.

Scheduled Adherence
Routine Task Refer to Frequency
PASS FAIL
Electrical safety testing and inspection of
Ansmann battery charger
 
Comments:

If the above checks pass, the equipment can be returned to use.

Checked By Signature Date

PQ – Fault Rectification

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
17
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE

If this PQ is in relation to a fault, then complete this form.

Before sending for repair or contacting the service provider or manufacturer, please consult the
‘Troubleshooting’ guide in the Operating Manual.

Description

Rectification

Date Rectified Fault Rectified By

Specialist Service Return to
User  Technician
 Provider
 Manufacturer


Preventative
Measures

Pass Fail Pass Fail

OQ Pre-Run PQ Functional
Checks   Test  

If the above checks all pass, the equipment can be returned to use.

Checked By Signature Date

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
18
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
PQ – Summary Report

ASSESSMENT OF PERFORMANCE QUALIFICATION

Serial number Insert Serial Device Number Here

Model MicroBio MBx Bioaerosol Sampler

Manufacturer Cantium Scientific Limited

Calibration certificate number Insert Calibration Certificate Number Here

Date returned to use

Deviations Operational Impact Acceptance Justification

Successful completion of the preceding checks indicates the equipment is operating to manufacturer
specifications following calibration, routine maintenance and functional checks. The equipment has
passed the Performance Qualification procedure and may now be returned to operational use.

Signature Print Name Date

PQ Completion

Deviations Approved

PQ Approved

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
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INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
Notes

Cantium Ref: A-00330 (IQ/OQ/PQ Generic Template) MicroBio MBx Bioaerosol Sampler
Issue / Date: 1 DD/MM/YYYY Serial Number Insert Number Here
Document Ref: Insert End User Document Ref Number Here User: Insert End User Name Here
20