calibration of autoclave.

      1.0       Objective

     To lay down a procedure of calibration of autoclave.

      2.0        Responsibility

      Microbiologist/QC-Executive.

       3.0       Accountability

      Head-QC executive

       4 .0     Procedure 

       4.1   Aseptically, remove one specimen of the relevant biological indicator from their original individual                   container.       

       4.2    Place the bacteriological spore strip in a clean sterile test tube/vial as its two sites i.e. bottom and top the                  fully loaded autoclave.

      4.3     Operate the autoclave as per autoclave operating procedure(121⁰c/15lbs).

      4.4      After autoclaving remove and transfer the strip aseptically in sterile 50ml SCDM (Soyabean casein digest                  medium).Carry out operation inside Laminar Air Flow.And label them accordingly.

       4.5     Incubate at 55⁰c-60⁰c for 7 days.

      4. 6      Positive control= Sterile 50ml SCDM incubated with unexposed bacteriological spore strips to                          steam sterilization.

       4.7       Negative control= sterile 50ml SCDM incubated without bacteriological spore strips.

       4.8    Observe the growth till 7 days.

       4.9    Interpretation

                 Growth within 3 days in positive control vials shows turbidity, no growth in negative control vials                    and test vials till 7 days indicates proper steam sterilization.

                 Growth within 3 days in positive control vials, no growth in negative control vials and growth in                      test vials in 7 days indicated failure in steam sterilization, hence faults can be rectified.

     

       4.10      Frequency         :  Once in a three months.

       4.11      Acceptance criteria  : 

      4.11.1   Temperature in chamber of autoclave should not vary 121 ± 2°C.

      4.11.2   The packaged biological indicator, paper carrier or ampoule, has particular labeled spore count                       per carrier  or ampoule not less than 10⁴ and not more than 10⁹spore.