P r o u d t o b e P a k i s t a n i

Global Pharmaceutical (Pvt.) Ltd.

STANDARD OPERATING Document #
Revision
No.
Effective Date Next Review On
GL/SOP 19-FEB-2007 19-FEB-2010
PROCEDURE 00
Copy #: Page #
VALIDATION OF STEAM STERILIZER (autoclave) 01 1
Author: Reviewed By: Approved By:

Zaki Ul Hassan S.N. Asghar Nadeem Panjatan

Microbiologist Signature A.M.Microbiologist Signature Plant Manager / MR Signature

1.0 PURPOSE

It is established for the proper validation of the sterilization process.

2.0 SCOPE

It is applicable to microbiological lab.

3.0 RESPONSIBILITIES

 Microbiologist.
 Q.C. Manager
 Lab Assistant.

4.0 PROCEDURE
 Biological Indicators to be used:
Strain of Bacillus stearothermophilus ATCC 7953
 Take 3-4 ampoules of above mentioned biological indicator in container in which the other filled
ampoule are placed which are to be sterilized in autoclave. These ampoules of biological indicators
are placed at different places of autoclave, to check the proper sterilization process. Close the
access lid and continue to operate the apparatus.( for 15 minutes at 15 lb,121° C )

 After completion of the sterilization procedure, and at a noted time with in 2 hours, aseptically add
each content of ampoule in 30 ml of soybean Casein Digest Medium. Incubate each media at a
temperature of 55-60 °C. Observe each inoculated medium at 24 hours and 48 hours, and every
1 or 2 days thereafter for a total of 7 days. If after 7 days of incubation there is no growth in the
medium test for sterilization is met.

Copyright: This Document is the exclusive property of Global Pharmaceutical (Pvt.) Ltd. And its contents must not be Communicated to
unauthorized persons, or persons outside the company without written consent of Management.