SOP for Testing of Compressed Air and Nitrogen Gas for Viable Count : Pharmaceutical Guidelines

SOP for Testing of Compressed Air and Nitrogen Gas for Viable Count

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 in the formulation of the parenteral department. Compressed air of 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 with wrapping paper all these accessories transferred into S.S. container and autoclave it at 121°C for 30 minutes.
5.2 Connect the sterile filter holder to flow meter which is attached to nitrogen gas/compressed air line.
5.3 Pass the sample through 0.2-micron filter of the quantity as per 5.8.
5.4 Disconnect the filter holder from the flow meter, open and put the membrane filter on S.C.D agar plate and incubate it at 30-35°C for 5 days.
5.5 After incubation, observe the results and record it as per Annexure-I
5.6 Limits: (a) Normal level: < 1 cfu/m3 (b) 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 m3 of 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.

6.0 ABBREVIATIONS

6.1 cfu= Colony Forming Unit
6.2 m3 = Meter cube
6.3 °C = Degree centigrade
6.4 S.C.D.= Soybean casein digest

Annexure-I
Report of Total Viable count in Compressed Air / Nitrogen gas

Name Of sample : _______________________________________________________
Sample Taken From: _____________________________________________________


Method: Membrane Filtration Technique (0.2μ)

     Result: ______________________ CFU/m3

     Limit:
                    Normal Level: < 1 CFU/m3

                   Action Level: > 1 CFU/m3
           
     Physical Observation :

     Evaluation Of Report :




Microbiologist

Date Of Report

Checked By
(Sign & Date)
(Sign & Date)

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