SOP on Plate Exposure to see Efficacy of Fumigation

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1.0 OBJECTIVE

The Purpose of this SOP to lay down the procedure for plate exposure in manufacturing area to see efficacy of fumigation.

2.0 SCOPE

This SOP is applicable for to describe the procedure of plate exposure to see efficacy of fumigation in Production Area, Storage Area, and Microbiology Department of Pharmaceutical Manufacturing Industry.

3.0 RESPONSIBILITY

Microbiologist or his designee shall be responsible for plate exposure for to see Efficacy of Fumigation.

The Head of microbiology is responsible for the effective implementation Of the SOP.

5.0 PROCEDURE

Precautions

  • Ensure that plates are pre incubated for 48 hrs.
  • Check for the contaminated plates before exposure.
  • Between microbiology laboratory to sampling locations carry the plates into closed S.S. containers.
  • Sanitize gloves with saniscrub during monitoring.

Plate Exposure Procedure:

  • Prepare sterile plates of  Soyabean Casein Digest Agar Media as per the procedure described in SOP for media preparation on the day of fumigation or prior to fumigation.
  • Pre-incubate the plates at 30 – 35° C for 48 hours, before use Check any type of contamination. Discard if any plate founds to be contaminated.
  • Stack the pre-incubated Petri dishes in a vertical plate’s stainless steel canister and take the canister to the fumigated area.
  • Before exposing the plates, ensure that the airflow of the fumigated area has been switched on and the area is free of the fumes.
  • Expose two plates at two ends of the fumigated room.
  • Remove the plate from the canister and take it to the point of exposure.
  • Remove the lid of the plate and place it beside the plate, in an inverted position.
  • Expose the plate for a period of 2 hours.
  • At the end of 2 Hours, place the lid back on the plate and mark the plate, mentioning the date and point of exposure, Exposed area, Exposed time.
  • Put the plate back into the canister.
  • Incubate the plate at 30 – 35° C for 5 days.
  • Count the number of colonies at the end of 5 days.
  • The count should not exceed 100 cfu/plate.
  • If the count exceeds 100, it indicates that fumigation was ineffective.
  • In this case, re-fumigate the area and repeat the entire procedure described above.

6.0 Training

As per Training SOP

7.0 Annexure:

Annexure I : Plate exposure After Fumigation Logbook

Annexure II : Plate exposure After Fumigation Report

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