STANDARD OPERATING PROCEDURE Operation and Calibration Procedure for Compressed Air Sampler
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STANDARD OPERATING PROCEDURE |
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Department: Quality Control
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SOP No.: QC/MB/
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Operation and
Calibration Procedure for Compressed Air Sampler
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Effective
Date:
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Review
Date:
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Page
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1.0
OBJECTIVE:
1.1
To lay down a procedure for Operation and Calibration of Compressed Air Sampler.
2.0
SCOPE:
2.1
This procedure is applicable to Compressed Air Sampler located in
microbiology laboratory at Pharma Private Limited.
ID No.
Model No.:
3.0
RESPONSIBILITY:
3.1
Microbiologist: Responsible for operation of instrument.
3.2
Section In-charge: Responsible for review the
procedure
3.3
QC Head: Responsible for implementing the Procedure.
3.4
QA Head: Overall compliance.
4.0
PROCEDURE:
4.1
Assembling:
4.1.1
Carry all the parts of compressed air sampler to the sampling area in carrying
kit.
4.1.2
Assemble the compressed air sampler as shown in below diagram:
4.1.3
Position
the stainless steel base (A) in front of the operator.
4.1.4
Fix the
inlet gassing source to (D).
4.1.5
Fix the
air flow meter connection (B) in the front to the backside elbow with a
triangle SS Plate.
4.1.6
Fix the
funnel support (J) on the base.
4.1.7
Insert the
“double O-ring” connection (F) into the funnel.
4.1.8
Position
the funnel (H) on its support and fix it to the air outlet.
4.1.9
Screw the
Contact Plate housing (I) to the funnel head.
Diagram of Compressed Air Sampler
4.2
Operation:
4.2.1
Connect the compressed air sampling point to the sampling kit through
hose pipe.
4.2.2
Now open the line of compressed air slowly.
4.2.3
Open ‘D’
and ‘D2’ valve and adjust the air flow on the flow meter to 100 litres / minute
(210 SCFH) to measure sample quantity.
4.2.4
Open the petri plate housing lid of air sampler and fix the media plate
into the stainless steel cup holder and screw it to the conical head.
4.2.5
Connect
the funnel to the compressed air sampler. Close the D2 valve, open the D1 valve
and start the stop-watch to count the sampling time.
4.2.6
Now the
sample will be collected on the petriplate.
4.2.7
Close the
D1 valve after 10 minutes (1000 litres of air are collected).
4.2.8
Unscrew
the head and keep the petri dish in stainless steel carrier.
4.2.9
Collect the air sample from remaining sampling points as per the above
procedure.
4.2.10
Before collecting the sample from the next sampling location sanitize the
contact plate housing head with 70% IPA.
4.2.11
After completion of sampling from all locations collect all exposed
plates in stainless steel petri plate carrier which is previously wiped with
70% IPA and bring to microbiology lab for incubation.
4.2.12
Count the
colony forming units in the plate at the end of incubation time and use
conversion table given in annexure-I to report the results as cfu/1000 litres
of compressed air (cfu/m3).
4.2.13
Record the usage details in usage log sheet (Annexure II).
4.2.14
Note: Plate housing lid of compressed air
sampler shall be sterilized in an autoclave at 121°C for 15 minutes.
4.2.15
Precautions:
4.2.16
The lid
should be removed only after the plate has been placed into the funnel to avoid
undue exposure of the lid and agar filled plate to environmental conditions.
4.2.17
The lid of
the contact plate should be placed face down onto a clean, sanitized area or
sterile bag when not on the plate.
4.2.18
Follow the gowning procedure as required by the respective department to
avoid the additional contamination.
4.3
Calibration:
4.3.1
The air flow meter of compressed air sampler shall be calibrated by
external party once in a year ± one month or after any maintenance work.
5.0
ABBREVIATIONS:
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QC:
Quality Control
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QA:
Quality Assurance
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SOP: Standard Operating Procedure
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IPA: Isopropyl
alcohol.
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cfu: Colony Forming Unit
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SCFH: Standard Cubic Feet per Hour
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