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SOPforTestingofCompressedAirandNitrogenGasforViableCount
Standard operating procedure to check the viable count of compressed air and Nitrogen gas used in formulation of parenterals.
1.0 OBJECTIVE
To ensure the control over viable count in nitrogen gas and compressed air in formulation Area.
2.0 SCOPE
This procedure is applicable to check the viable count of compressed air and Nitrogen gas used informulation of parenteraldepartment. Compressed air o
Solid Dosage area.
3.0 RESPONSIBILITY
3.1 Doing : Technical Assistant Microbiologist / Executive
3.2 Checking : Executive/Manager
4.0 ACCOUNTABILITY
Head of the Department
5.0 PROCEDURE
5.1 Take the filter holder and insert 0.2 micron membrane filter in it. Wrap the filter holder withwrappingpaper all this accessories transferred in to S.S.
container and autoclave it at 121oC for 30 minutes .
5.2 Connect the sterile filter holder to flow meter which is attached tonitrogengas/compressed air line.
5.3 Pass the sample through 0.2micron filter of the quantity as per 5.8.
5.4 Disconnect the filter holder from flow meter, open and put the membrane filter on S.C.D agar plateand incubate it at 3035oC for 5 days.
5.5 After incubation, observe the results and record it as per AnnexureI
5.6 Limits: a Normal level: < 1 cfu/m3b Action level:>1 cfu/m3
5.7 Frequency of testing:
1 Once per quarter for compressed air and nitrogen gas. In Parenteral Dept.
2 Once per quarter for Compressed air In Solid Dosage Area.
5.8 Sample quantity: Adjust the flow meter to 6 m3/hr & draw the sample for 10 min to sampled 1 m3of air or nitrogen gas.
5.9 Sampling Point: Compressed Air & Nitrogen Gas in Parenteral Department.
AnnexureI
Report of Total Viable count in Compressed Air / Nitrogen gas
Limit:
Normal Level: < 1 CFU/m3
Evaluation Of Report :
Microbiologist Checked By
Date Of Report
Sign & Date Sign & Date
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