Procedure for action to be taken on the adverse report of environmental monitoring of sterile Area


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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