SOP for Collection and Testing of Samples During Process Simulation

1.0 PURPOSE

To lay down the stepwise procedure collection of samples during Process Stimulation in the sterile facility and it’s testing procedure.

2.0 SCOPE

This is applicable to Microbiology lab

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Sample collection from compounding area

5.1.1 While entering the compounding area follow the procedure of entry & exit mentioned in SOP.
5.1.2 Collect the Pre filtered media in sterile-screw capped bottle perform the Bioburden according to SOP.

5.2 Sample collection from the aseptic area

5.2.1 For entry & exit in the aseptic area follow the procedure mentioned in SOP.
5.2.2 Collect 200 ml sample from the first filtration in the sterile-screw capped bottle.
5.2.3 Perform the growth promotion test and pH according to SOP for media preparation and growth promotion test.
5.2.4 Collect 200 ml sample from the second filtration in the sterile-screw capped bottle.
5.2.5 Incubate the samples at 20-25°C for 7 days followed by 30-35°C for again 7 days.
5.2.6 Collect the sample of Vials, Flip of seals and Rubber stopper in sterile screw capped bottle containing 100 ml soybean casein digest medium at the end of the filling of that particular pack size.
5.2.7 In case of vial bigger than 5 ml. Samples shall be collected after capping and sealing.
5.2.8 Inject Soybean casein digest medium in each vial under strict aseptic condition.
5.2.9 Incubate the samples at 20-25°C for 7 days followed by 30-35°C for 7 days.
5.2.10 Sample the compressed air through compressed air sampler according to SOP.
5.2.11 Incubate the plate at 30-35°C for 5 days.
5.2.12 Collect first 4 filled vials for observation.
5.2.13 Collect the left out solution in a sterile container and incubate the samples at 20 – 25°C for 7 days followed by 30-35°C for 7 days.
5.2.14 After completion of the media fill incubation perform the post-media fill growth promotion test of the vials according to SOP.
5.2.15 Container closure integrity shall be tested whenever any new pack size is used.
5.2.16 Perform the environment monitoring such as Plate exposure, Air sampling, Surface, Finger dab, Personnel hygiene according to SOP. Record the result of passive air sampling.

5.3 Destruction of the media

5.3.1 Discard the contaminated vials in the terminal sterilizer and drain the media in ETP.
5.3.2 The vials, which are not contaminated, should be discarded in the ETP.
5.3.3 The empty vials should be crushed in vial crusher
Note: All the Activities should be carried out according to Media Fill.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 °C - Degree Centigrade
6.3 ETP – Effluent Treatment Plant

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