SOP for Environmental Monitoring for Surfaces and Equipment

PURPOSE

To lay down the procedure to provide guidelines to microbial monitoring of personnel who is working in clean rooms in order to reduce the source of product contamination.

SCOPE

This operational procedure is applied for monitoring of personnel by the RODAC plate method in a clean room.

RESPONSIBILITY

QC (Microbiologist) - Monitor and measure the impact of our activities on personnel and to establish targets for ongoing improvement.

PROCEDURE

• Prepare the SCDA medium as per manufacturer instructions. And pour in the contact plate and wait for it to solidify.
• Take the contact plate. Open the lid of the contact plate and take the sample by pressing the plate smoothly on the surface which has to be monitored, after sampling, close the lid of the plate.
• During surface sampling press the contact plate with uniform pressure to make contact of the entire media surface.
• Sanitize the sampled area with 70% IPA and mope the surface with a lint-free mope.

• After sampling carry out the contact plate for incubation.
• Incubate the contact plate at 20-25°C for 72 hrs. And then at 30-35°C for 48hrs.
• Record the observation of the surface monitoring by contact plate.

Table

GRADE	Acceptable level of total microbial count (cfu/100cm²)
A	<1 cfu/100cm²
B	NMT 5 cfu/100cm²
C	NMT 50 cfu/100cm²
D	NMT 100 cfu/ 100cm²
Fungus	NMT 10 cfu/100cm²

REFERENCE

Nil

ABBREVIATIONS

QC: Quality Control

SCDA: Soya Casein Digest Agar

% : Percentage

SOP: Standard operating procedure

IPA: Isopropyl alcohol

HRS: Hours

CFU: Colony Forming Unit

ANNEXURE

Nil

REVISION HISTORY

Nil

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