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SOP for Handling of Biological Indicators


Standard operating procedure for storage and handling biological indicators for qualification of sterilization process.

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
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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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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