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SOP for Entering in Sterility Testing Room


Standard operating procedure of entry in sterility testing room having U.V light.

1.0  Objective

       To describe procedure for entry in sterility testing room.

2.0  SCOPE

       This  procedure is applicable whenever any person enter in sterility room for any work.

3.0  Responsibility

3.1  Doing      : Lab. Assistant/Tech. Assistant (Microbiologist)/Executive
3.2  Checking : Executive/Manager

4.0  Accountability

       Head of the Department

5.0  Procedure

5.1  Remove the wrist watch and jewellery before entering in sterile area.
5.2  Wash the hand with soap & rinse with 70.0% I.P.A solution & let it be air dried.
5.3  Enter in Airlock –I.       
5.4  Remove the slipper in Airlock I & enter in Air lock II.
5.5  Remove the street garments & hang it on the hanger or keep it on s.s. stool provided in Air lock II and mope the hand with 70% IPA
5.6  Enter in Air lock –III.    
5.8  Take a sterile garment from sterile dress cabinet. Put on the head mask first. Ensure that hair & nose is covered properly.
5.9  Put on the gown. 
5.10  Cover the head mask under the body gown & close the zipper.
5.11  Wear the booty & tie it in such a  way  that it covers the ankle  part of the gown.
5.12  Take pair of sterile disposable gloves from drawer of sterile dress cabinet & wear it in such a way that the fingers should not  touch the outer surface of gloves.
5.13  Discard the gloves which are ruptured  or having pinholes.
5.14  Tug  in the sleeve  ends properly inside the gloves.
5.15  Spray both  the hands  with 70% I.P.A & let it be air dried.
5.16  Enter in sterile area by opening the door with the help of elbow, taking care not to touch your fingers any where and  ensure that the door of second air lock is not open.
Note: Disinfect the gloves frequently with sterile 70% Isopropyl alcohol provided in the Sterile area
5.17  Switch 'OFF' the U.V light and switch 'ON' tube light.
5.18  After completion of the work ,follow the same sequence in reverse order while coming out of the sterile area .
5.19  Collect all used garments and gloves in closed bucket provided in Airlock-I
5.20  Maintain the record of person entering in sterile area as per Annexure-I 

6.0  Abbreviations

       S.S   = Stainless steel  
       I.P.A= Isopropyl Alcohol
       %     = Percentage
       U.V  = Ultraviolet
ANNEXURE-I
QUALITY CONTROL DEPARTMENT
MICROBIOLOGICAL  LAB.
RECORD FOR ENTERING IN STERILITY TESTING ROOM
DATE
NAME OF PERSON
ENTERED IN STERILITY
AREA
PURPOSE OF
ENTRY
TIME
REMARKS


































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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