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SOP for Validation of Autoclave with Biological Indicator for Sterilization Efficiency


Standard operating procedure to validate the Autoclave using Biological Indicators for sterilization efficiency.

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. 
5.5.3  Inform the QC manager /engineering dept. for corrective action

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.
:

Ref.  SOP No.
:

Make
:

Model No.
:

Organism used : Bacillus stearothermophilus
Lot No :------------------------------------
Date of Sterilization --------------------               Exp. Date -----------------------------------
Date of completion ----------------------             Population ---------------------------------
Location
Growth of Bacillus stearothermophilus observed (+ve) /not observed (-ve) 55-60 °C
Remarks
1








2








3








Date








Observed by








Observation: The Autoclave is working satisfactorily /not working satisfactorily, requires/does not require maintenance.
Analyst                                                                                                     Checked by
Date                                                                                                         Date
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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chibuzo jnr said...

great well written , you are really helping us

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