CARAWAY PHARMACEUTICALS

Document Number CP/QC/MIC/SOP/001

Revision Number 01
STANDARD OPERATING Date of Effectiveness Jan 2014
PROCEDURE Date of Next Review Jan 2016
Page No 1 of 3
Title: Monitoring of Autoclave

1.0 PURPOSE

It is established for the proper monitoring of autoclave (steam sterilization process)

cycle.

2.0 SCOPE

It is applied in sterile area (Injectables as well as Microbiology Lab).

3.0 RESPONSIBILITIES

Microbiologist
Lab Assistant

4.0 PROCEDURE

Theory:
o In a plastic vial, a white paper strip on which spores of Geobacillus
stearothermophilus (ATCC 7953) have inoculated and a glass ampoule in
which nutrient agar and also a pH-color indicator has covered.

Biological indicators to be used:

o Strain of Geobacillus stearothermophilus ATCC 7953 supplied by gke
(Japan).

Process:
o 03 biological indicators are placed at different places (places are shown in
monitoring checklist) in autoclave, so that to check the proper sterilization
process (01 biological indicator is placed in incubator as a Control). Close the
access door and continue to operate the apparatus.
Written By Reviewed by Approved by

Ali Furqan Muhammad FAZAL WAHAB

Ali Furqan Muhammad

Sr.Microbiologist Signature Quality Control Manager

Sr.Microbiologist Signature
Signature
 CARAWAY PHARMACEUTICALS
Document Number CP/QC/MIC/SOP/001
Revision Number 01
STANDARD OPERATING Date of Effectiveness Jan 2014
PROCEDURE Date of Next Review Jan 2016
Page No 2 of 3
Title: Monitoring of Autoclave
o After completion of the sterilization process, remove the vials from the autoclave
and cool them down for 15 min. at room temperature. The chemical indicator is
stick outside on the label, if there is no change in color of chemical indicator (it
is process indicator), it means sterilization didnt occur.
o Crush the inner glass ampoule to get the culture medium in contact with the
spore plate that is placed inside the vial.
o Incubate each spore-containing vial (autoclaved vials and the control vial) at a
temperature of 55 60 C.
o Observe each vial daily for the growth (growing/living bacteria produce acids
and change the pH-indicator color) in the form of color change (see table below).

Interpretation of Result:
o The control vial shows growth after 1-2 days.
o If the test vials dont change their color after 2 days, the sterilization was
successful.
o If the test vials change their color, stop the autoclave and repeat the test
procedure, placing several indicator vials throughout the autoclave.
o If the above color change observed again, examine the autoclave and check its
function.

Product (Bio- Medium color without Medium color with

Indicator) growth growth

Geobacillus.
Stearothermophilus Violet Yellow-Green
spores

Written By Reviewed by Approved by

Ali Furqan Muhammad FAZAL WAHAB

Ali Furqan Muhammad

Sr.Microbiologist Signature Quality Control Manager

Sr.Microbiologist Signature
Signature
 CARAWAY PHARMACEUTICALS
Document Number CP/QC/MIC/SOP/001
Revision Number 01
STANDARD OPERATING Date of Effectiveness Jan 2014
PROCEDURE Date of Next Review Jan 2016
Page No 3 of 3
Title: Monitoring of Autoclave
Indicator color without Indicator color with
Chemical Indicator
exposure exposure

Chemical paper strips Pure Yellow Pure Black

Frequency:
o Autoclaves (Injectable & Microbiology Lab) are monitored after every 15 days
(twice a month).
Note:
o Do not crush the inner ampoule until the vial is at room temperature! Hot glass
ampoules may burst the plastic vial.
o The bio-indicator must not be used for dry heat (risk of glass ampoule and
plastic vial explosion).

Written By Reviewed by Approved by

Ali Furqan Muhammad FAZAL WAHAB

Ali Furqan Muhammad

Sr.Microbiologist Signature Quality Control Manager

Sr.Microbiologist Signature
Signature