To lay down a procedure for monitoring Temperature, Relative Humidity and Differential Pressure of microbiology lab.
This SOP is applicable for monitoring and recording the temperature (0C), Relative humidity (%) and differential pressure (mm of water) using digital hygrometers and Magnehelic gauge for Differential Pressure in microbiology lab.
- Microbiologist responsible for monitoring and verification of Temperature, Relative Humidity and Differential Pressure.
- Head-Concerned department is responsible to ensure the prevailing Temperature, Relative Humidity and Differential Pressure is within limits as per SOP.
- Department Head & QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions
QA : Quality Assurance
°C : Degree Centigrade
RH : Relative Humidity
mm WC : Millimeter of water column
Min : Minimum
Max : Maximum
HVAC : Heating Ventilation Air Conditioning
- Check the calibration status of the instrument.
- Check the temperature and relative humidity displayed in the digital hygrometer monitor.
- Record the Temperature and Relative Humidity at starting of the shift + 30 min and after every 4 hours ± 30 minutes for production, warehouse till completion of the activity or end of shift whichever is later as per Annexure – I.
|Media Preparation Room|
|MLT and LAL Testing Room|
- Acceptance Criteria:
Temperature: NMT (Not More Than) 250C
Relative Humidity: NMT 60%
- Procedure for monitoring of Temperature and Relative Humidity by Digital hygrometer (Model: HTC-1)
- Record the previous day minimum and maximum Temperature and Relative Humidity.
- Recording of previous day minimum and maximum Temperature & Relative Humidity shall be performed at the time of observing daily initial reading.
- Record the minimum and maximum Temperature and Relative Humidity by pressing “Memory” key. Press one time memory key to record max. Temperature & max. Relative Humidity of previous day and again press memory key to record min. Temperature & min. Relative Humidity.
- Delete the minimum and maximum reading from the memory of hygrometer that is required to leave memory space to record the next day min. and max. reading.
- For resetting the minimum & maximum value, press “RESET” button provided back side of the digital hygrometer with the help of pin.
- Procedure for monitoring of Differential Pressure in Different Areas
- Enter in the respective area and ensure that all doors of microbiology are tightly closed.
- Ensure that the HVAC is in running condition.
- Open the door of respective area and ensure zero (0) set, while door is opened.
- Take the magnehelic gauge reading in the reference of positive and negative pressure of rooms.
- Record the value.
|Media Preparation Air lock|
|MLT and LAL Testing Room|
Frequency: Twice a day (Morning and afternoon)
Acceptance criteria :
- Forms and Records (Annexures)
- Temperature and Relative Humidity Record – Annexure-II
- Record for Differential pressure – Annexure-III
- Master copy – Quality Assurance
- Controlled copies – Microbiology Lab
Reason for Revision