The purpose of this SOP is to lay down the procedure for recording of temperature, relative humidity (RH) & Pressure differential of a particular area from digital thermo hygrometer / data logger & calibrated Magnehelic gauge.
This SOP shall be applicable for recording of temperature, relative humidity (RH) & Pressure differential through the digital thermo hygrometer / data logger & calibrated Magnehelic gauge which are placed in the specified areas at manufacturing facility of XXX.
- Authorized designee of the concerned department shall record the temperature, humidity & pressure differential at defined frequency, minimum/maximum temperature and relative humidity of the respective area at defined period and maintain the record of temperature, humidity & pressure differential.
- Head of the concerned department and quality assurance shall be responsible for the effective implementation of the procedure.
- Precaution: Only Calibrated Digital Thermo hygrometers / data logger & Magnehelic gauge shall be used during routine monitoring for temperature, Humidity and pressure differential.
- Authorized designee of the concerned departments shall maintain the record of Temperature, relative humidity (F/QAXXX) & pressure differential (F/QAXXX) of applicable area.
- Monitoring & acceptance criteria of temperature & humidity shall be handling according to SOP for monitoring of temperature & humidity (XXX).
- Monitoring & acceptance criteria of pressure differential shall be handling according to SOP for monitoring of pressure differential (XXX).
- Recording of Temperature & Humidity :
- Temperatureand relative humidity shall be recorded in the area prior to start the operation and according to frequency specified in SOP/QA038 or batch record of respective product.
- Temperature and relative humidity shall not be recorded in the area if there is no any operation being commenced in the area. When there is no activity in the area and AHU is off, record the temperature and relative humidity as ‘’ —‘’.
- Authorized designee of the quality assurance shall verify the temperature and relative humidity (RH) displayed on the screen in Annexure – I (Temperature and Humidity Recording, F/QA070/01).
- Recording of Minimum/ Maximum Temperature and Relative Humidity;
- Authorized designee of respective department shall record the “Minimum Temperature and Relative Humidity” and “Maximum Temperature and Relative Humidity” in Annexure – II (Temperature and Relative Humidity Recording, F/QAXXX) by pressing [MEMORY] key and the same shall be recorded daily irrespective of that the area was not in use and air handling units are not in operation. In the case the area not in use/utilities of the area etc. not working then the Minimum/maximum temperature and relative humidity shall not be recorded according to specified in SOP/QAXXX.
- Operation of digital thermo hygrometer shall be handling according to specify in SOP/QAXXX.
- Authorized designee of the concerned department shall record the minimum and maximum temperature and relative humidity according to procedure and frequency specified in SOP (QAXXX).
- If the Minimum and Maximum temperature and relative humidity of the area “in use like material storage/production in operation” observed beyond the specified limit at the time of recording of the Minimum and Maximum temperature and relative humidity, the same shall be handled through SOP for handling of Incident and Deviation (QAXXX). If the temperature and relative humidity of the area not in use go beyond the limit then the same shall not be investigated.
- Excursion in temperature & RH shall be handled according to SOP/QAXXX.
- Authorized designee of concerned department shall record the temperature in the areas for which relative humidity shall not be applicable.
- Recording of Pressure differential :Ensure that the AHU’s in all areas (Cubicle and adjacent areas) are operational for the last 5 to 10 minutes. Ensure the ‘0’ setting of manometers by moving the knob provided on the manometer boxes wherever applicable or by opening the door of the area. Ensure that the door of the cubicle and adjacent areas are in closed condition.
- Read the value on manometer, which is directly corresponding to the indicator needle. If the indicator needle rests in between two divisions on the scale, the average of both readings to be considered.
e. g. : Magnehelic manometer
Range : 0 – 6 mm of water gauge
Least count: 0.2 (Value of each division)
If the indicator needle is in between `0.4′ and `0.6′, read `0.5′.
- Record the observation in Annexure (F/QAXXX).
- Limit of pressure difference in cubicle with respect to adjacent area is given in Annexure (F/QAXXX) and same should be recorded in the Annexure – III (F/QAXXX) for respective areas.
- Frequency for monitoring & recording and excursion during monitoring shall be handling according to SOP (QAXXX).
- Temperature / RH & pressure monitoring record shall be verified by respective department in charge / head on monthly basis.
Trainer : Head – Quality Assurance
Trainees : All concerned personnel of QA, Production, Packaging, Stores, QC, and Engineering & Microbiology.
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No.2 : Head of Department – Production
Controlled Copy No.3 : Head of Department – Quality Control
Controlled Copy No.4 : Head of Department – Warehouse / Stores
Controlled Copy No.5 : Head of Department – Engineering / Maintenance
Controlled Copy No.6 : Head of Department – Microbiology
Controlled Copy No.7 : Head of Department – Packing
Original Copy : Head – Quality Assurance
|Annexure I||:||Temperature and Humidity Recording|
|Annexure II||:||Minimum/ Maximum Temperature Recording|
|Annexure III||:||Pressure differential monitoring record|
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|01||00||–||New SOP||New SOP|