SOP For Procurement Storage and Handling of Biological Indicators is described in this post which you can follow in the section of microbiological lab.
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Objective:
This procedure has been established to define the procurement, storage and handling of biological indicators used for checking the effectiveness of moist heat sterilization or autoclavation.
Scope:
This procedure is
applicable to the sterile area (Manufacturing & Microbiological Testing
Lab).
Responsibility:
Microbiologist.
Sterile Area Pharmacist.
Microbiology Lab Attendant.
Accountability:
Quality Control Manager.
Procurement:
Generate or write the demand order/purchase order for biological indicator according to the need.
After receiving the biological indicator, inspect visually the physical condition, labelling details, and documents of the biological indicator contained in the pack.
Storage:
Store the biological indicator at a temperature of NMT 25oC and relative humidity of 40%-65% under Lock & Key.
Procedure:
Transfer Aseptically 02 ampoules of Biological indicators to sterility room under LFH.
Follow the proper gowning procedure for entering in the sterile testing area of microbiological testing room.
Open the ampoule containing spores of Geobacillus Stearothermophilus under LFH and pour in pre-sterilized glass Petri plate and pour 20-25ml of agar and let the plate solidify.
Set the plate for incubation at a temperature of 55oC for 48hrs to check the growth of bacterium.
After expiry, if still unused Biological indicators are available then dispose off them by treating in moist heat sterilization cycle at 121°C/15psi/15minutes.
Record the activity of autoclavation as well as disposal in the respective logbooks.
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