REVITAL HEALTHCARE (EPZ) LTD

T I T L E : SOP FOR ENVIRONMENTAL MONITORING FOR PERSONNEL.

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

RHEL/QA/SOP/162 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

ENVIRONMENTAL MONITORING FOR

PERSONNEL 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 PERSONNEL.

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

RHEL/QA/SOP/162 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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 REVITAL HEALTHCARE (EPZ) LTD
T I T L E : SOP FOR ENVIRONMENTAL MONITORING FOR PERSONNEL.

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

RHEL/QA/SOP/162 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.
DEFINATION
SCDA Medium-Soyabean Casein Digest Agar.
RODAC Plate-Replicate Organism Detection and Counting.
RESPONSIBILITY:
QC (Microbiologist) - Monitor and measure the impact of our activities on personnel and to establish
targets for ongoing improvement.
Media preparation
For fingerprint sterile SCDA plate .pour about 20ml of sterile SCDA medium in each pre-sterilized and
dried plate (90mm size) under laminar airflow bench and allow it to solidify.
After solidification of medium place SCDA petri plate at 30°C – 35°C in inverted position in S.S tray
and incubate for 48 hours.
After incubation period observe the plates for contamination.
Discard contamination plate if any found as per S.O.P
Procedure
 Take the print of fingertips from both gloves on two different SCDA plate.
 Make the plate with left and the right hand, name of the person, working area and date.
 Instruct the person to change the gloves immediately and discard the of gloves in S.S Bowl
containing 70% filtered IPA.
 After sampling, incubate the plates at 30°C-35°C for 72hrs and then record the results in
Annexure.

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 REVITAL HEALTHCARE (EPZ) LTD
T I T L E : SOP FOR ENVIRONMENTAL MONITORING FOR PERSONNEL.

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

RHEL/QA/SOP/162 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

Grade Alert Level Action Level Limits

A - - <1cfu
B 3cfu 4cfu 5cfu
C 15cfu 20cfu 25cfu
D 30cfu 40cfu cfu
REFERENCES
Pharmaceutical guidelines.
ABBREVIATIONS:
RODAC:Replicate Organism Detection and Counting
HRS :Hours
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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