SOP for Handling of Biological Indicators

1.0 OBJECTIVE

To clearly define the procedure for procurement, storage and handling of Biological Indicator.

2.0 SCOPE

This procedure is applicable for Biological Indicators as per listed below.
2.1 B. subtilis
2.2 B. stearothermophilus

3.0 RESPONSIBILITY

3.1 Doing : Tech. Asst./Executive
3.2 Checking : Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Raise the P.O. as per the requirement for biological indicator.
5.2 On receipt of the material check the physical condition of pack labelling details, certificates and expiry date.
5.3 Store it in cool dry place away from sterilants under Lock & Key.
5.4 Maintain the stock..

5.5 Procedure for Use :

5.5.1 Take out Biological indicators strip from container.
5.5.2 Follow the gowning procedure as per the sop.
5.5.3 Enter in the inoculation/ microbiological room.
5.5.4 Open the container under culture cabinet & take out the strips with help of sterile Forcep.
5.5.5 For steam sterilization validation, carefully put each B. stearothermophilus strips in sterile petriplates & proceed as per sop.
5.5.6 For dry heat sterilization validation , Put each strip in aluminium foil & fold properly & proceed as per SOP.
5.5.7 Proceed Treated BI within 2 hrs.
5.6 On expiry, if stock remains, dispose the Biological indicators after treating it in sterilization cycle as per SOP. at 121°for 30min.
5.7 Record the disposition.

6.0 ABBREVIATIONS

P.O. =Purchase Order
DHS = Dry Hear Sterilizer

Also see: New Genetically Engineered Biological Indicators

ANNEXURE-I 

QUALITY CONTROL DEPARTMENT

MICROBIOLOGICAL LIMITED

STOCK OF BIOLOGICAL INDICATOR

NAME OF BIOLOGICAL INDICATOR ORGANISM :------------------------------------

Date  of receipt	Lot No. of indicator	Quantity Received	Mfg date	Exp date	Issued on	Issued Quantity	Balance Stock	sign

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