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Bioaerosol Sampler
IQ / OQ / PQ
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
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
2
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
IQ / OQ / PQ Documentation
Document Issue
Insert Document
1 First Issue Creation Date Insert Name Here Insert Name Here
Here
Distribution
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.
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
4
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
Equipment Distributor
Service Provider
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 Specification
* 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.
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
IQ – Summary Report
Successful completion of the preceding checks indicates the equipment has passed the
Installation Qualification procedure and may now proceed to Operational Qualification.
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
The MicroBio MBx Bioaerosol Sampler conforms to regulatory and safety standards as detailed below.
Referencing:
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.
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
9
INSERT END USER COMPANY LOGO HERE INSERT DISTRIBUTOR LOGO HERE
OQ – Pre-Run Checks
No damage should
1 Inspect kit for damage -
be present
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
If the above checks all pass, the sampler is ready to use, following instructions in the
MBx Bioaerosol Sampler Operating Manual by trained operatives.
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
11
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.
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
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
Successful completion of the preceding checks indicates the equipment has passed the
Operational Qualification procedure and may now be released for operational use.
OQ Completion
Deviations Approved
OQ 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
PQ – Trigger Factors
PQ – Recalibration
Return to manufacturer /
Operating Manual Annually
service provider
Service provider used Date submitted New certificate number PASS FAIL
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
15
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)
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.
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.
Scheduled Adherence
Routine Task Refer to Frequency
OK Discrepancy
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:
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
PQ – Fault Rectification
Description
Rectification
Preventative
Measures
If the above checks all pass, the equipment can be returned to use.
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
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.
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
19
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
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