REVITAL HEALTHCARE (EPZ) LTD

T I T L E :SOP FOR ENVIRONMENTAL MONITORING FOR SURFACES AND

EQUIPMENT

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/163 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

ENVIRONMENTAL MONITORING FOR

SURFACES AND EQUIPMENT PROCEDURE
APPROVED BY: SIGN & DATE
Mariannah kimatu
(Quality control-Microbiologist)
(Prepared By)

Nancy Mwangi
(Ass. Quality Assurance Manager)
(Reviewed By)  
 
Lucy caster Muoti
(Quality Assurance Manager)
(Reviewed By)  
 
Vikrant Chowgule
(Head Quality)
(Approved By)  

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 REVITAL HEALTHCARE (EPZ) LTD
T I T L E :SOP FOR ENVIRONMENTAL MONITORING FOR SURFACES AND
EQUIPMENT

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/163 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

SOP FOR ENVIRONMENTAL MONITORING

FOR PERSONNEL
APPROVED BY: SIGN & DATE
Mariannah kimatu
(Quality control-Microbiologist)
(Prepared By)

Nancy Mwangi
(Ass. Quality Assurance Manager)
(Reviewed By)  
 
Lucy caster Muoti
(Quality Assurance Manager)
(Reviewed By)  
 
Vikrant Chowgule
(Head Quality)
(Approved By)  

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 REVITAL HEALTHCARE (EPZ) LTD
T I T L E :SOP FOR ENVIRONMENTAL MONITORING FOR SURFACES AND
EQUIPMENT

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/163 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

REVISION HISTORY
Revision No. Revised Page(s) Description Date
00 00 Original issue 01/03/2021

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T I T L E :SOP FOR ENVIRONMENTAL MONITORING FOR SURFACES AND
EQUIPMENT

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/163 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

PURPOSE:
To lay down the procedure to provide guideline to microbial monitoring of personnel who is working in
clean room in order to reduce the source of product contamination.
SCOPE:
This operational procedure is applied for monitoring of personnel by RODAC plate method in 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 to solidify.
 Take the contact plate. Open the lid of the contact plate 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 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.

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 REVITAL HEALTHCARE (EPZ) LTD
T I T L E :SOP FOR ENVIRONMENTAL MONITORING FOR SURFACES AND
EQUIPMENT

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/163 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

TABLE 1
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

REERENCES
N/A

ABBREVIATIONS:
N/A : Not Applicable
QC : Quality Control
SCDA: Soya Casein Digest Agar
% : Percentage
SOP : Standard operating procedure
IPA : Isopropyl alcohol
HRS : Hours
CFU : Colony Forming Unit

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 REVITAL HEALTHCARE (EPZ) LTD
T I T L E :SOP FOR ENVIRONMENTAL MONITORING FOR SURFACES AND
EQUIPMENT

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/163 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

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