Monitoring of steam sterilizer by using ampoules bioindicator
1.     Purpose:-                         

                         To assure the sterility of the items sterilized by steam in the steam sterilizer (autoclaves).
2.     Scope:-

               This procedure is applicable to all the autoclaves present in Production Department and Microbiological Lab.
  1. HSE Statement:-
                        Not Applicable.
4.     Responsibilities:-

                               i)      Manager Quality Control is responsible to ensure that procedure & formats are followed entirely as approved.
                             ii)       Microbiologist is responsible to perform the test.
                           iii)      Lab attendant is responsible to assist the officer microbiologist for the preparation of test materials.
5.     Materials:-

            5.1 Aluminum Foil
5.2 Sterile Forceps
           5.3 Incubator
           5.4 Ampoule bioindicator
           5.5 Glass vial.
   6 Definitions:

  6.1 Steam Sterilization:-
                                        The destruction of all forms of microbial life on an object by exposing the object
to moist heat for 15 minutes at 121° C under high pressure.
 6.2 Biological Indicator
A device used to validate items being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms (usually bacterial spores), of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.

7.0 Flow Chart:-

8 Description:-
8.1 Procedure:-           
8.1.1 Place the vial containing ampoule bioindicator in a suitable clean beaker and wrap it by aluminum
        foil to avoid any accidental breakage.
8.1.2 The vial should be placed at strategic sites in autoclaves thought to be fugitive from sterilization e.g.
at the bottom and at the middle of autoclave.
8.1.3 Load the items to be sterilized in and run the autoclave at the desired temperature and time.
8.1.4 The temperature of the autoclave should not exceed 1250C. This would damage the bioindicator and can be demonstrated by the color change without increase in turbidity.
8.1.5  After the autoclaving, remove the vial from the autoclave and push down the cap to break the ampoule to mix the spores with the growth medium.
8.1.6  Incubate BI at 55-600C for 24 hours.
8.1.7  Record the results by observing the change in the color and turbidity of suspension in the BI vial.
8.1.8  A non-sterilized BI should be incubated that serve as a control.
8.2. Frequency:-

9            Record:-
Autoclave Monitoring Using Ampoule Bioindicator

10. Reference:-
                      United States Pharmacopoeia 35
                          Manufacturers Instructions Manual

11 Distribution:-

This SOP has to be distributed in below mentioned Departments:-

Sr. NO
Distributed to
Quality Control Department

Quality Management Department


12. Revision History:-
Date                                        Changes