SOP for Entering in Sterility Testing Room : Pharmaceutical Guidelines

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 the procedure for entry in sterility testing room.

2.0 Scope

This procedure is applicable whenever any person enters 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 wristwatch and jewelry before entering the 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 Airlock II.
5.5 Remove the street garments & hang it on the hanger or keep it on s.s. stool provided in Airlock II and mope the hand with 70% IPA
5.6 Enter in Airlock –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 a pair of sterile disposable gloves from the 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 the sterile area by opening the door with the help of elbow, taking care not to touch your fingers anywhere and ensure that the door of the second airlock 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



































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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.
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