SOP for Cleaning and Operation of Laminar Air Flow Workstation : Pharmaceutical Guidelines

SOP for Cleaning and Operation of Laminar Air Flow Workstation

Standard operating procedure to clean, operate and precautions for laminar air flow used for microbial analysis to maintain the class 100 area.

1.0 OBJECTIVE

To lay down the procedure for the cleaning and operation of Laminar Air Flow Workstation.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head Quality Control Department.

5.0 PROCEDURE

5.1 Cleaning

5.1.1 Clean the outer surface and working table of Laminar Airflow Workstation with a lint-free cloth moistened in disinfectant solution.
5.1.2 Clean the working table of Laminar Airflow Workstation before and after every operation. Clean the outer surface of Laminar Airflow Workstation daily.
5.1.3 Clean the pre-filters of Laminar Airflow Workstation once in a month with compressed air and record.

5.2 Operation

5.2.1 Switch on the UV lamp and airflow half an hour before starting the work.
5.2.2 Red indicator will glow and air will start to come out from the HEPA filters.
5.2.3 Switch off the UV lamp after minimum 30 minutes.
5.2.4 Press the switch cum indicator of “Light”. Red indicator and tube lights will glow.
5.2.5 Check and ensure that the manometer reading is as per the specified limit (0.5 inches of water)
5.2.6 Perform the microbiological testing under the Laminar Airflow Workstation
5.2.7 After completion of testing, clean the working table with 70% Isopropyl Alcohol.
5.2.8 Switch off the ‘’Light” at the end of the testing for the day.
5.2.9 Press the switch cum indicator of “UV”. Red indicator and UV lights will glow.
5.2.10 Switch on the UV lamp for minimum 30 minutes.
5.2.11 Switch off the UV lamp & Airflow after 30 minutes.
5.2.12 Record the activity in the log book.

5.3 Precautions

5.3.1 Check the calibration status of the manometer.
5.3.2 Do not switch on the UV light during working period.
5.3.3 Switch on the “Airflow” of Laminar Airflow Workstation before 30 minutes of the microbiological testing.
5.3.4 If the manometer reading is less than or more than 0.5 inches of water, inform Engineering Department immediately.

5.4 Calibration

Once in 6 months, get the laminar airflow calibrated by an external agency, by carrying out the DOP test, Air velocity test and particle count.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 HEPA: High-Efficiency Particulate Air
6.3 UV: Ultraviolet
6.4 DOP: Di-Octyl Phthalate
6.5 QC: Quality Control
6.6 Dept.: Department
6.7 LAF: Laminar Air Flow

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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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