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.
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