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.
- 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:-
Monthly
9
Record:-
Autoclave
Monitoring Using Ampoule Bioindicator
10. Reference:-
Manufacturers
Instructions Manual
11 Distribution:-
This SOP has to be distributed in below mentioned
Departments:-
|
Sr. NO
|
Distributed to
|
Received
(Current)
|
Returned
(Obsolete)
|
|
1
|
Quality Control
Department
|
|
|
|
2
|
Quality Management
Department
|
|
|
12.
Revision History:-
Date Changes
N/A