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GENERAL TEST PROCEDURE (GTP) Page 1 of 3

Bioburden Testing of Prefiltered Solution by


Title Effective Date 04/01/05
Membrane Filtration
GTP Number GTP 121-01 Review Date 03/01/07

REVISION SUMMARY

GTP Number Date Revised Reason for Revision


GTP 121-00 20/10/2003 First issue
GTP 121-01 04/01/20005 The format of the GTP is changed as per SOP QA
030-00 and the procedure is revised.

Prepared By Checked By Approved By


Name B.V.RAMA KISHAN N.RAJENDRA KUMAR SANJAY SHAH K.R.PRAKASH
Signature
Date
GENERAL TEST PROCEDURE (GTP) Page 2 of 3
Bioburden Testing of Prefiltered Solution by
Title Effective Date 04/01/05
Membrane Filtration
GTP Number GTP 121-01 Review Date 03/01/07

1.0 SCOPE

1.1 To lay down the procedure for determining the total aerobic microbial counts in
product solution by membrane filtration method.
1.2 If the product is known to have to antimicrobial activity give washings to the
membrane with peptone water.

2.0 MATERIALS REQUIRED


2.1 Sterilized SCDA Agar / m (HPC)
2.2 Product sample
2.3 Sterilized Membranes
2.4 Sterilized Forceps
2.5 Sterilized Filter cups.

3.0 PROCEDURE:
3.1.1 Total Bacterial Count by membrane Filtration Method:
3.1.2.1 Collect 100ml of the prefilter solution being tested in sterilized bottle.
3.1.2.2 Filter the prefilter solution through 0.45 membrane having 47 mm
diameter by applying vacuum.
3.1.2.3 If the product being an antibiotic wash each filter membrane with three
quantities each of about 100 ml of a suitable medium such as 0.1 %
sterile peptone water containing 0.1 ml of ß-lactamase enzyme
containing 100000 units.
3.1.2.4 Transfer the membrane filter onto the surface of preincubated SCD / m
(HPC) agar.
3.1.2.5 Incubate the plate at 30 – 35 0C for 48 hrs for bacterial enumeration
followed by 20 – 25 ºC for 72 hrs for yeasts and molds enumeration.
3.1.2.6 Count the CFU and report as CFU per 100 ml.
Prepared By Checked By Approved By
Name B.V.RAMA KISHAN N.RAJENDRA KUMAR SANJAY SHAH K.R.PRAKASH
Signature
Date
GENERAL TEST PROCEDURE (GTP) Page 3 of 3
Bioburden Testing of Prefiltered Solution by
Title Effective Date 04/01/05
Membrane Filtration
GTP Number GTP 121-01 Review Date 03/01/07

3.1.2.7 Prepare negative control plate by filtering 100 ml sterile water through
the membrane and place the membrane on the surface of media and
incubate along with the test sample.

4.0 ABBREIVATION
4.1 SCD-Soya bean casein digest
4.2 m(HPC) – membrane Heterotrophic plate count agar

5.0 REFERENCE
5.1 Sterile drug products produced by Aseptic process – cGMP guidelines (September
2004)

END OF DOCUMENT

Prepared By Checked By Approved By


Name B.V.RAMA KISHAN N.RAJENDRA KUMAR SANJAY SHAH K.R.PRAKASH
Signature
Date