PROCEDURE

 (For alert limit)

• If the colony forming units exceed the alert limit

a) Increase the frequency of cleaning from once to twice a shift.

b) Ensure that the disinfectants are used as per schedule mentioned in respective SOP

    and Cleaning of the processing area is carried out as per respective SOP .

    (For action limit)

• If the colony forming units exceed the action limit, investigate / check the following whether

• Entry / Gowning procedure is followed.

• Cleaning is done as per SOP in processing and filling area.

• Disinfectant schedule is followed as per respective SOP

• Prolonged Maintenance job performed if any.

• Personnel traffic in the area is increased.

• Major Power shut down has occurred.

• Positive pressure in the area is disturbed.

• Operator with history of adverse fingerprint reports worked in the area.
• Time of plate exposure.

• Any other incidence, which can increase the bioburden of the area, took place.

• Inform to QC dept. through QA dept. in writing the outcome of above investigation with Products / Batches manufactured and filled during the period.

• During the investigation period, increase the frequency of cleaning to twice a shift.

• Request QC dept. to identify the organism and suggest suitable disinfectant for the organism identified.

• Proceed as per the suggestions given by QC dept.

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