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1.0 OBJECTIVE
To describe the procedure to validate autoclave with biological indicator for sterilization efficiency.2.0 SCOPE
This is applicable to validate autoclave with biological indicator for sterilization efficiency.3.0 RESPONSIBILITY
Microbiologist - Quality Control
4.0 ACCOUNTABILITY
Manager - Quality Control.
5.0 PROCEDURE
5.1 Frequency –Monthly
5.2 Organism – Bacillus stearothermophilus.
5.3 Perform the initial count of one strip of Bacillus stearothermophilus spores from the
strips of given lot / batch which are to be used for validation purpose.
5.4 Autoclave validation
5.4.1 Load the autoclave chamber with routine
accessories and glassware.
5.4.2 Take three strips and mark with location and
put inside the autoclave as describe below.
5.4.3 Put one strip in inner side, one side in
middle and one strip outer side, near the door of the autoclave chamber.
5.4.4 Keep one strip unexposed for + ve control.
5.4.5 Run the autoclave cycle at 121ºC and 15 lb
pressure for 20 minutes/validated time.
5.4.6 Mark the pre-incubated sterile SCDM (Soyabean
Casein Digest Medium) tubes (20ml) with location no., date etc. and transfer
the strips aseptically to respective labeled SCDM tubes.
5.4.7 Transfer one unexposed for + ve control.
5.4.8 Keep one SCDM tube un-inoculated for – ve
control.
5.4.9 Incubate all the tubes at 55ºC- 60ºC for 7
days.
5.4.10 Observe the tubes daily up to 7 days for
turbidity / growth in the SCDM tubes having strips.
5.4.11 Positive control should show growth within 72
hours.
5.5 Interpretation
5.5.1 If no growth observed in any one of the SCDM
tube having autoclaved strips, test complies.
5.5.2 If growth observed in any one of the SCDM
tube, identity the growth of B. stearothermophilus
performing gram staining, simultaneously comparing it with + ve control. In
case of failure, investigate for non compliance of validation and repeat the
cycle.
6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
6.2 SCDM - Soyabean Casein Digest Medium
ANNEXURE
–I
AUTOCLAVE VALIDATION
WITH BIOLOGICAL INDICATOR
Asset
ID No.
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Ref. SOP No.
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Make
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Model
No.
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Organism used : Bacillus
stearothermophilus
Lot No
:------------------------------------
Date of Sterilization
-------------------- Exp. Date -----------------------------------
Date of completion ---------------------- Population ---------------------------------
Location
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Growth of Bacillus stearothermophilus observed (+ve)
/not observed (-ve) 55-60 °C
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Remarks
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1
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2
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3
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Date
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Observed by
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Observation: The Autoclave is working satisfactorily /not
working satisfactorily, requires/does not require maintenance.
Analyst
Checked by
Date Date
great well written , you are really helping us
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