Temperature and Relative Humidity Monitoring, Purpose:
Temperature and Relative Humidity Monitoring, To lay down the procedure for monitoring of Temperature & Relative Humidity (%) at the Packaging area.
Temperature and Relative Humidity Monitoring, Scope:
This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows :
Operator
[][]To follow the laid down procedure
Executive, Packaging
[][]To monitor and check the procedure is followed
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
Annexure:
N/A.
Procedure :
Precaution :
[][]Do not use a new hygrometer unless it is calibrated.
[][]When any hygrometer is shifted from one location to another, allow to stabilize the device prior to record the temperature / Relative Humidity (%).
[][]Check the due date of calibration of the hygrometer and magnehelic gauge before taking reading.
[][]Ensure that temperature and Relative Humidity (%) readings are taken before going to operation.
[][]Temperature and Relative Humidity (%) (using Digital Hygrometer)
[][]Ensure that no dust is accumulated over the sensor.
[][]Read the temperature and relative humidity (%) values displayed on the screen of digital hygrometer and record.
Area
[][]Packing Hall, Waste, Cleaner’s, Printing, IPC Room, Office Executive and Packing Material Staging.
Temperature
[][]NMT 25°C
Relative Humidity (%)
[][]NMT 60 %
Frequency
[][]Twice in a shift, first before starting the operation and second after four hours.
[][]If the reading is not within limit at any time of operation, inform the Engineering department immediately.