1.0 OBJECTIVE :
The objective of this SOP is:
1.1 To lay down a procedure for monitoring personnel of sterile area in aseptic area by taking finger and garment dabs by contact plate method.
2.0 RESPONSIBILITY:
2.1 The Quality Assurance Personnel shall be :
2.1.1 Responsible for Sampling.
2.2 The Microbiologist shall be :
2.2.1 Responsible for sampling and interpretation of results.
2.3 Executive - Quality Control shall be :
2.3.1 Responsible for checking and approving the results.
3.0 ACCOUNTABILITY:
Head - Quality Control
Test : By Contact Plate Method .
4.1 Prepare Contact Plate as per SOP ( Use Rodac Plates 40-45 mm in diameter instead off normal plates of 90mm diameter. ) .
4.2 Materials for sampling are transferred into the sterile area as per SOP.
4.3 Enter in the respective areas by following the proper entry (gowning) procedure.
4.4 Before entering into the area spray the outer portion of the container followed by moping with a lint free cloth with 70% IPA solution.
4.5 Pre-incubated contact plates of sterile SCDA media are exposed and hand impressions dress impressions (arm-pits , fore-head, fore-arm , belly etc) are taken at the place of working.
4.6 After taking the contact-plate samples close the lid of the petri –plate and write the name, nature of work and batch number of the product at the base of the plate.
4.7 Bring those plates to the microbiology laboratory and incubate at 20-25 °C for 72 hrs followed by 30-35°C for 48 hrs.
4.8 Observe the plates after completion of incubation period and note the observations in the format giver in monitoring plan.
4.9 Frequency , limits and locations are mentioned in the monitoring plan.
4.10 If the bio-burden is found out of the specified limit ,proceed as per the SOP
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