1.0 PURPOSETo lay down procedure for preparation of dresses for sterilization.
2.0 SCOPEThis SOP is applicable for preparation of dresses for sterilization used in sterility testing area of Microbiology lab in Quality Control.
4.0 ACCOUNTABILITYHead of Department
5.1 Procedure for Coding of Sterility Dresses5.1.1 Put the same serial number on one set of dress (Hood, gown and Booties) with prefix MIC/DR followed by three digit serial number eg. MIC/DR/001, MIC/DR/002 and so on.
5.1.2 Put the serial no. on the dress by using black permanent marker on selected areas of dress for better identification as follows:
220.127.116.11 Hood: inner side corner
18.104.22.168 Gown: Inner side of collor
22.214.171.124 Booties: Inner side top
5.2 Inspection of Dresses
5.2.1 Ensure that the dresses have been washed as per SOP
5.2.2 Arrange the washed dresses in sets (one set consists of hood, gown and a pair of booties) in a single dress bag with identical serial number.
5.2.3 Inspect the gown carefully for the intactness of the stitches and zippers. Check for any stain / torn or worn out areas particularly around armpits, elbow and seat and also check waist ribbon is intact. If any part of the overall gown is torn or worn out, discard the complete set of dress and shall be replaced with new one.
5.2.4 Inspect the hood carefully for the intactness of the stitches and the tying strings. Check for any stain / torn or worn out areas. If any part of the hood is torn or worn out, discard the hood and replace with a fresh washed hood with same serial number.
5.2.5 Inspect each booty carefully for the intactness of the stitches. Check for any stain / torn or worn areas around toes and bottom portion. Check the intactness of tying strings of each booty. If any torn or worn out booty is found, discard the same and replace with a fresh washed booty with same serial number
5.2.6 Similarly, check each dress bag for the intactness of the stitches and for any torn or worn out areas. If any part of the dress bag is torn or worn out, discard the same and replace with a fresh one.
5.3 Preparation of Dresses for sterilization5.3.1 Half fold the arms and legs of the sterile gown inside out.
5.3.2 Holding the dress from the waist level and fold it.
5.3.3 Half fold the hood from inside out in one fold.
5.3.4 Half fold both booties inside out in one fold.
5.3.5 Open the dress bag.
5.3.6 Place each set of inspected dress (gown, hood and one pair of booties) in the dress bag in a sequence such that first keep one pair of folded booties, then keep folded gown, followed by hood.
5.3.7 Close the dress bag properly.
5.3.8 Follow step no. 5.2.1 to 5.2.6 for preparing the required number of dress sets for sterilization.
5.3.10 Sterilize the dresses in the steam sterilizer as per SOP.
5.3.7 Record the details in sterilization log for dresses.
5.4 Destruction of Dresses
5.4.1 Destroy the dresses after three months or 80 sterilization cycles whichever is earlier.
5.4.2 Record the dress receipt, issuance and destruction details.
5.5 Procedure for Coding of Goggles5.5.1 Put the same serial number on Goggles and Elastic band with prefix MIC/G followed by three digit serial number eg. MIC/G/001, MIC/G/002 and so on.
5.5.2 Put the serial number on the goggles and elastic band by using black permanent marker.
5.6 Inspection of Goggles5.6.1 Ensure that the goggle lens have not any cracks and scratches
5.6.2 Vision of goggle lens should be clear
5.7 Procedure for Goggles Sterilization5.7.1 Remove the elastic band and both clips from goggles.
5.7.2 Autoclave these components separately i.e. goggle lens does not come in contact with other components as per SOP.
5.7.3 Record the details of sterilization cycle in sterilization log for goggles.
5.8 Destruction of goggles5.8.1 Destroy the goggles after 20 sterilization cycles or if found damaged.
5.8.2 Record the goggles receipt, issuance and destruction details.
6.1 SOP : Standard operating procedure
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.
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