SOP for Entry and Exit in Area for Microbiological Analysis : Pharmaceutical Guidelines

SOP for Entry and Exit in Area for Microbiological Analysis

Standard operating procedure to visit the area dedicated for microbiological analysis.

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).

3.0 RESPONSIBILITY

Microbiologists

4.0 ACCOUNTABILITY

Head QA & QC

5.0 PROCEDURE

Entry is strictly restricted to non-working personnel in microbiological Testing Area.

5.1 Entry into the Microbiological testing area (clean room area)

5.1.1 For entry in Airlock 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 Airlock 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.
5.1.4 Disinfect your hand up to the elbow with a disinfectant solution (70% IPA) kept in a clean container in Airlock I.
5.1.5 Open the door of Airlock – II and enter.
5.1.6 Take a sterile dress from the cabinet open the zip bag and first wear the headgear by covering up to the neck.
5.1.7 Wear the sterilized boiler suit (one piece of clothing) and then wear the booties. Finally disinfectant the hand by spraying filtered 70% IPA and allows to dry.
5.1.8 Stand in front of the mirror provided in Airlock II and ensure that all the body parts, except for eyes to be covered with sterile garments.
5.1.9 Wear Sterilized gloves and disinfect the gloves again with filtered 70% IPA.
5.1.10 Open the door of Airlock – III and enter to inside, wait till the door is completely closed.
5.1.11 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 into the Exit Airlock IV.
5.2.2 Remove the uniform and gloves, put them in a clean covered container provided to keep used cleanroom garments in the airlock IV. Wear the factory uniform and slippers in Airlock I and come out from Airlock 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 the 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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