SOP for Temperature & Differential Pressure Monitoring In Microbiology Laboratory

PURPOSE

To lay down the procedure for temperature and differential pressure monitoring in microbiology laboratory.

SCOPE

This procedure is applicable for temperature and differential pressure monitoring in Microbiology Laboratory located in Quality Control Department at Pharmainfo Limited.

RESPONSIBILITY

• QC Officer (Microbiologist): Recording of Temperature and Differential pressure
• Engineering Head: Ensuring proper environmental conditions available in microbiology laboratory
• QC Head: Overall responsible for effective implementation

PROCEDURE

• Ensure that AHU in microbiology laboratory is switched ON.
• Ensure that the digital thermohygrometer clock is calibrated.
• Allow about 30 minutes to lapse after switching ON the AHU.
• Read the temperature displayed on digital thermohygrometer clock in degree Celsius in each room of microbiology laboratory.

• Record the observation in Annexure No.: 1 temperature monitoring in microbiology laboratory.
• Ensure that all the doors are properly closed and no air leakage is present in the doors.
• Ensure that the magnehelic gauges are calibrated.
• In door closed position read the pressure differential reading on magnehelic gauge of main air lock with respect to outside environment.
• Similarly, check the differential pressure of media preparation room with respect to main air lock, first airlock of testing area with respect to main air lock, second air lock of testing area with respect to first and testing area with respect to second airlock of testing area.
• Record the reading in Annexure No.: 2 Differential pressure monitoring in microbiology laboratory.
• The difference in pressure of cleaner area shall be NLT 1.5 mm water column with respect to less cleaner area.
• Carry out the monitoring twice a shift in the morning and in the evening.
• In case the temperature and differential pressure in microbiology laboratory is out of limits, inform QC head and raise incidence report as per SOP. Call engineering department and get it rectified.
• Do not carry out any testing activity in case the temperature and differential pressure is out of limit.

ABBREVIATIONS

AHU: Air Handling Unit

LAF: Laminar Air Flow

mm WC: Millimeter Water Column

ANNEXURES

Annexure No. 1: Temperature Monitoring in Microbiology Laboratory

Annexure No. 2: Differential Pressure Monitoring in Microbiology Laboratory

REVISION HISTORY

Nil

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