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SOP For Testing of Compressed Air and Nitrogen Gas For Viable Count - Pharmaceutical Guidelines

This standard operating procedure outlines the testing of compressed air and nitrogen gas for viable counts in pharmaceutical formulations. The objective is to ensure control over viable counts in these gases used in formulation areas. The SOP describes collecting gas samples using a sterile filter holder connected to the gas lines. Membrane filters are used to collect any microbes, then incubated and observed for colony growth. Acceptable limits of less than 1 colony forming unit per cubic meter are outlined, along with action levels and sampling frequencies. Points of sampling for different formulation areas are listed.

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2K views2 pages

SOP For Testing of Compressed Air and Nitrogen Gas For Viable Count - Pharmaceutical Guidelines

This standard operating procedure outlines the testing of compressed air and nitrogen gas for viable counts in pharmaceutical formulations. The objective is to ensure control over viable counts in these gases used in formulation areas. The SOP describes collecting gas samples using a sterile filter holder connected to the gas lines. Membrane filters are used to collect any microbes, then incubated and observed for colony growth. Acceptable limits of less than 1 colony forming unit per cubic meter are outlined, along with action levels and sampling frequencies. Points of sampling for different formulation areas are listed.

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2017515 SOPforTestingofCompressedAirandNitrogenGasforViableCount:PharmaceuticalGuidelines

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.

COMPRESSED AIR NITROGEN GAS

Vial Wash Room. Ampoule Manufacturing Room


Cap wash Room Insulin Manufacturing Room
Ampoule wash Room Insulin Filtration Room.
Tank wash Room Ampoule Filtration Room.
HPHV & Ventilator Room. Ampoule filling Room.
5.8 Physical Observation: Observe visually Presence of oil.
6.0ABBREVIATIONS
6.1 cfu= Colony Forming Unit
6.2 m3 = Meter cube
6.3 oC = Degree centigrade
6.4 S.C.D.= Soybean casein digest

AnnexureI
Report of Total Viable count in Compressed Air / Nitrogen gas

Name Of sample : _______________________________________________________


Sample Taken From: _____________________________________________________

Method: Membrane Filtration Technique 0.2

Result: ______________________ CFU/m3

Limit:
Normal Level: < 1 CFU/m3

Action Level: > 1 CFU/m3



Physical Observation :

Evaluation Of Report :

Microbiologist Checked By
Date Of Report
Sign & Date Sign & Date

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical
blog since 2008. Signup for the free email updates for your daily dose of pharmaceutical tips.
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