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SOP For Bioburden Test

This standard operating procedure outlines the process for conducting bioburden tests in clean areas at Ethical Drugs Ltd. The SOP describes procedures for determining: 1) Viable particle counts using the settling plate count method by exposing petri dishes in the clean area and incubating them to count colony forming units 2) Non-viable particle counts using a Met one instrument to sample air and record particle counts of different sizes 3) Frequency of testing and acceptance criteria for particle counts based on the grade of the clean area. The SOP aims to monitor clean areas and ensure particle counts are within specified limits.

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3K views2 pages

SOP For Bioburden Test

This standard operating procedure outlines the process for conducting bioburden tests in clean areas at Ethical Drugs Ltd. The SOP describes procedures for determining: 1) Viable particle counts using the settling plate count method by exposing petri dishes in the clean area and incubating them to count colony forming units 2) Non-viable particle counts using a Met one instrument to sample air and record particle counts of different sizes 3) Frequency of testing and acceptance criteria for particle counts based on the grade of the clean area. The SOP aims to monitor clean areas and ensure particle counts are within specified limits.

Uploaded by

Bejoy Karim
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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  • Procedure of Bioburden Test for Clean Area: Details the procedures for conducting bioburden tests in clean areas, including objectives, scope, and specific procedural steps required to ensure compliance with clean area standards.

STANDARD OPERATING PROCEDURE eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
Section : Microbiology Revision Date : 01.01.2020
SOP No. : EDL/MB/SOP001 Revision No. : 01
Issue Date : 01.01.2017 Page : 1 of 2
Title : Procedure of Bioburden Test for Clean Area.
OBJECTIVE:
To determine Viable and Non-viable particle count in air of Clean Area.
SCOPE:
The SOP is applicable to Sterility Testing and Parenteral product manufacturing area.
PRECAUTIONS:
1. The personnel must wear apron, mask, cap, hand gloves, working sandal during operation.
2. All glass wares and utensils must be sterile.
3. All operations must be done aseptically.
RESPONSIBILITY:
Microbiologist/QC authorized personnel
ACCOUNTABILITY:
Quality Control Manager

PROCEDURE:

A. For Viable Particle count:


Settling Plate Count Method:

01. Ensure that the area to be monitored for Viable particle count must be thoroughly cleaned as per
SOP.
02. Place at least 4 sets of petri dishes (Dia : 90 mm) containing sterile Nutrient Agar Media in different
grade clean areas.
03. Aseptically expose the petri dishes for 2 hours.
04. After the lapse of the period cover the petri dishes aseptically.
05. Keep the petri dishes invertly in the Incubator and incubate at 37° C for 18 to 24 hours.
06. Observe the growth and count the cfu per Petri dish and determine average.
07. Record the results in the Annexure-I.
08. Observe the count is within limit for specified area.
09. Frequency : The next day after fumigation.

Written by Checked by Approved by Authorized by

Sign : Sign : Sign : Sign :


Microbiologist Sr. QC Officer QC Manager Director (Ope. & Maint.)
Date : Date : Date : Date :
STANDARD OPERATING PROCEDURE eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
Section : Microbiology Revision Date : 01.01.2020
SOP No. : EDL/MB/SOP001 Revision No. : 01
Issue Date : 01.01.2017 Page : 2 of 2
Title : Procedure of BioburdenTest for Clean Area.
B. For Non-viable Particle count:
01. Ensure that the area to be monitored for Non Viable particle count must be thoroughly cleaned
as per SOP.
02. Instrument used : Met one Instrument.
03. Operate the instrument as per SOP.
04. Sample the air at the rate of 1ft3/minute.
05. Take Air sample from a location concerned operation.
06. Repeat and take two (02) such readings and determine the average.
07. Record the results in the Annexure-I.
08. Observe the count is within limit for specified area.
09. Frequency : Operation to be done before going to production or sterility testing.

Annexure-I
Location of Petri No. of Average no. Permitted No. of particles Permitted no. of
dish exposure Petri dish of cfu per cfu per petri obtained/ft3 particles /ft3
petri dish dish 0.5-5µ > 5µ 0.5-5µ > 5µ
Grade A or Class Less than 1 100 None
100 area
Grade B or Class NMT 5 1000 None
100 area
Grade C or Class NMT 50 10000 50
10000 area
Grade D or Class NMT 100 100000 500
100000 area

Written by Checked by Approved by Authorized by

Sign : Sign : Sign : Sign :


Microbiologist Sr. QC Officer QC Manager Director (Ope. & Maint.)
Date : Date : Date : Date :

STANDARD OPERATING PROCEDURE eTHiCaL DruGS LTD. SIDDHIRGANJ, NARAYANGANJ Section : Microbiology Revision Date : 0
STANDARD OPERATING PROCEDURE eTHiCaL DruGS LTD. SIDDHIRGANJ, NARAYANGANJ Section : Microbiology Revision Date :

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