SOP for Monitoring of Personnel in Aseptic Area

OBJECTIVE

The objective of this SOP is to lay down a procedure for monitoring personnel in a sterile area in an aseptic area by taking finger and garment dabs by contact plate method.

RESPONSIBILITY

The Quality Assurance Personnel shall be responsible for Sampling.

The Microbiologist shall be responsible for sampling and interpretation of results.

Executive - Quality Control shall be responsible for checking and approving the results.

ACCOUNTABILITY

Head - Quality Control

PROCEDURE

Test: By Contact Plate Method

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• Prepare Contact Plate as per SOP (Use Rodac Plates 40-45 mm in diameter instead of normal plates of 90mm diameter).
• Materials for sampling are transferred into the sterile area as per SOP.
• Enter the respective areas by following the proper entry (gowning) procedure.
• Before entering into the area spray the outer portion of the container followed by moping with a lint-free cloth with 70% IPA solution.
• Pre-incubated contact plates of sterile SCDA media are exposed and hand impressions and dress impressions (armpits, forehead, forearm, belly, etc) are taken at the place of working.
• 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.

• Bring those plates to the microbiology laboratory and incubate at 20-25°C for 72 hrs followed by 30-35°C for 48 hrs.
• Observe the plates after the completion of the incubation period and note the observations in the format given in the monitoring plan.
• Frequency, limits, and locations are mentioned in the monitoring plan.
• If the bio-burden is found out of the specified limit, proceed as per the SOP.

ANNEXURE

Nil

REVISION HISTORY

Nil

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