In this Sop, we will explain about Qualification Of Compressed Air And Nitrogen Gas in the Pharmaceutical Industry.
Page Contents
1. PURPOSE
To write down the procedure to monitor compressed air/gases (Nitrogen)for microbiological, non-viable particulate, oil, and moisture
2. SCOPE
This SOP is applicable for monitoring of compressed air and nitrogen gas in different production areas for microbiological, non-viable particulate, oil, and moisture content
3. RESPONSIBILITY
Microbiologist
Quality Control Manager
4. PROCEDURE
4.1 Physical Observation:
4.1.1 Compressed air and nitrogen gas should qualify the following test
- a) Moisture content
- b) Oil presence
4.1.2 Moisture Content
4.1.2.1 Observe visually presence of moisture, no moisture observed on dry tissue paper
4.1.3 Oil Presence
4.1.3.1 Oil-free air, nitrogen is required. Observe no traces of oil observed on dry tissue paper.
4.2 Microbiological confirmation
4.2.1 Viable Particle Count::
4.2.1.1 Take the filter holder and insert a 0.45µm membrane filter in it. Wrap the filter holder with wrapping paper all these accessories transferred into the SS container and autoclave it at 121ºC for 30 minutes
4.2.1.2 Connect the sterile filter holder to the flow meter which is attached to the nitrogen gas/compressed air line
4.2.1.3 Pass the sample through 0.45 µm filter of the quantity as per 5.8
4.2.1.4 Disconnect the filter holder from the flow meter, open and put the membrane filter on the S.C.D agar plate, and incubate it at 30-35ºC for 5 days.
4.2.1.5 After incubation, observe the results and record them as per the validation report.
4.2.1.6 Limits:
1) Nitrogen Gas (a) Normal level: ˂1CFU/m³ (b) Action level: > 1CFU/m³
2) Compressed air Total microbial count limit – NMT 100 CFU/m³
4.2.2 Sterility Test
4.2.2.1 Clean the air sampling apparatus as per SOP cleaning of the microbiology laboratory apparatus.
4.2.2.2 Fill 100ml 0.1% peptone water in sampling apparatus, wrap the apparatus and other glassware and accessories required for testing of compressed air, and Nitrogen and sterilize by autoclaving at 121ºC and 15psi for 30 minutes (peptone water sterilization for 20 minutes).
4.2.2.3 Prepare the FTM and TSB media as per the SOP Media preparation and Growth promotion test.
Dispense the media in 100ml test tubes.
4.2.2.4 Sterilize the tubes containing 100ml media by autoclaving at 121ºC and 15psi pressure for 20 minutes.
4.2.2.5 After autoclaving, allow the material cool to room temperature and pre incubate the FTM and TSB as per media preparation.
4.2.2.6 Transfer the sampling apparatus in a closed SS container to the sterile area through pass box and personnel must be entered into personnel entry airlocks of the sterile area as per SOP For Entry-Exit Procedure For Sterile Area.
4.2.2.7 Take the sampling apparatus inside the manufacturing area from material entry and remove the wrapping.
4.2.2.8 Connect the compressed air to the inlet of the sampling apparatus, start slowly compressed air supply by opening the stopcock of the outlet port for 10 minutes.
4.2.2.9 Stop the compressed Air disconnect the line from the apparatus and immediately seal the inlet and outlet of the apparatus with a sterile cotton plug and aluminum foil and the same procedure will be followed for Nitrogen gas
4.2.2.10 Follow the exit procedure and come out from the manufacturing area.
4.2.2.11 Transfer the apparatus to the sterility room through hatch box
4.2.2.12 Carry out the sterility test by membrane filtration method using a 100 ml sample as per SOP for the Sterility Test.
4.2.2.13 Incubate the tubes for 14 days and visually examine the tubes daily and its conclusion for macroscopic evidence for growth.
4.2.2.14 If no evidence of growth observed in any of the tubes the sample to be examined for the test complies with the test of sterility
4.2.2.15 If evidence of microbial growth is found in the text the sample examined does not comply with the test for sterility.
4.2.2.16 Carry out the failure investigation as per SOP for investigation of sterility failure
4.2.3 TestingFrequency
1) Monthly/Any major maintenance occur
4.2.4 Sample quantity: Adjust the flow meter to 6 m³/hr & draw the sample for 10 min to sampled 1m³ of air or nitrogen gas.
4.2.5 Sampling Point: Compressed air & Nitrogen Gas in Production Department
| COMPRESSED AIR | NITROGEN GAS | |
|
Vial washing area |
Liquid blowing bottle room |
Injection manufacturing Room |
| Inj Filling and sealing room | Injection Filling and sealing room | |
| Liquid filling and sealing room | Liquid Manufacturing room | |
5. QUALITY RECORD(s)/FORM(s)
The following Quality records shall be generated for control of Company Quality Records
| Required Record | Form Reference No. |
| Validation of compressed air | |
| Validation of Nitrogen gas |
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