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.

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:-
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
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