Sterility testing of filtered compressed air and nitrogen gas

Sterility testing of filtered compressed air and nitrogen gas

1.     Purpose:-                         

To ensure the sterility of filtered compressed air and nitrogen gas used in filling of Sterile Injectable Products.

2.     Scope:-

This procedure is applicable to filtered compressed air and nitrogen used in sterile process area.

3.     HSE Statement:-

Not Applicable.

4.     Responsibilities:-

                               i)      Manager Quality Control is responsible to ensure that procedure & formats are followed entirely as approved.

                             ii)       Microbiologist is responsible to perform the test.

                           iii)      Lab attendant is responsible to assist the officer microbiologist for the preparation of test materials.

5.     Materials:-

5.1 Sterile 100ml Soya Bean Casein Digest Medium (SCDM) in a screw capped conical flask.

5.2 Sterile rubber cork with air nozzle for sampling.

      6. Definitions:-

           6.1   Sterility:

                               Within the strictest definition of sterility, an article is deemed to sterile when there is complete absence of viable microorganisms. Absolute sterility cannot be practically demonstrated because it is technically unfeasible to prove a negative absolute.

  7 Flow Chart:-

  

      8. Description:-

      8.1 Procedure:-

   8.1.1 Transfer the sterilized materials into the aseptic area via pass through.

   8.1.2 Enter into aseptic area after sterile gowning.

   8.1.3 Aseptically remove the screw cap of the TSB flask and fit the rubber cork on the neck of the flask

in such a way that the lower end of the nozzle should be dipped in the TSB medium. .

8.1.4  Let the compressed air or nitrogen escape for one minute.

8.1.5  Connect the nitrogen or compressed air tube to the nozzle of the TSB flask.

8.1.6  Bubble the sample into medium for 1 minute.

8.1.7  After sampling aseptically remove the cork assembly and close the flask with screw cap tightly.

8.1.8  Incubate the samples at 20-25⁰C for 14 days.

8.1.9  Observe the presence or absence of any growth in TSB and record the results

  8.2. Frequency:-

                   Monthly

  9. Records:-

       9.1 Sterility testing of Nitrogen and Compressed Air

       9.2 Sterility testing of Nitrogen and Compressed Air

10. References:-

                 United States Pharmacopoeia 35

11. Distribution:-

This SOP has to be distributed in below mentioned Departments:-

Sr. NO	Distributed to	Received (Current)	Returned (Obsolete)
1	Quality Control Department
2	Quality Management Department

 

 

12 Revision History:-

Date                                        Changes

N/A