1.0 OBJECTIVE:To lay down a procedure for entry and exit in Microbiological Testing Area (MLT Room and Sterility Room).
2.0 SCOPE:This SOP shall be applicable for personnel entry in the Microbiological Testing Area (restricted area).
4.0 ACCOUNTABILITY:Head QA & QC
5.0 PROCEDURE:Entry is strictly restricted for non-working personnel’s in microbiological Testing Area.
5.1 Entry into Microbiological testing area (clean room area):5.1.1 For entry in Air lock I enter the password then open the door and enter to inside.
5.1.2 Remove factory uniform, cap, foot ware and street clothes in Air lock I.
5.1.3 Make a necessary entry in an Entry / Exit record for Microbiological Testing Area with date, in time in hrs and purpose. Remaining column to be filled after completion of work.
5.2.3 Disinfect your hand up to elbow with disinfectant solution (70% IPA) kept in a clean container in Air lock I.
5.1.3 Open the door of Air lock – II and enter.
5.1.4 Take a sterile dress from the cabinet open the zip bag and first wear the head gear by covering up to the neck.
5.1.5 Wear the sterilized boiler suit (one piece clothing) and then wear the booties. Finally disinfectant the hand by spraying filtered 70% IPA and allows to dry.
5.1.6 Stand in front of mirror provided in Air lock II and ensure that all the body parts, except for eyes to be covered with sterile garments.
5.1.7 Wear Sterilized gloves and disinfect the gloves again with filtered 70% IPA.
5.1.8 Open the door of Air lock – III and enter to inside, wait till the door is completely closed.
5.1.9 Open the door of the Passage by pushing the door and enter to passage.
5.2 Exit from Microbiological testing Area:5.2.1 After completion of the work; come in to the Exit Air lock IV.
5.2.2 Remove the uniform and gloves, put them in a clean covered container provided to keep used clean room garments in the airlock IV. Wear the factory uniform and slippers in Air lock I and come out from Air lock I.
5.2.3 Write the exit time, remark if any and sign in Entry / Exit record.
5.3 Precautions:5.3.1 Only Authorized person can enter in Microbiology Section.
5.3.2 The person suffering from cough and cold shall not enter in Microbiological Testing Area.
5.3.3 The person with wound shall not enter Microbiological Testing Area.
6.0 ABBREVIATIONS:SOP : Standard operating procedure
QC : Quality Control
IPA : Iso Propyl Alcohol
LAF : Laminar Air Flow
SS : Stainless Steel
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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