Monitoring of Room Condition, Purpose:
Monitoring of Room Condition, To lay down the procedure for monitoring of Temperature, Relative Humidity (%) and Pressure Gradient at the Production Area.
Monitoring of Room Condition, Scope:
This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.
Definitions / Abbreviation:
[][]N/A.
Responsibilities:
[][]The Roles and Responsibilities are as follows :
Operator
[][]To follow the laid down procedure
Executive, Production
[][]To monitor and check the procedure is followed
Manager, Production
[][]To implement this correctly
Manager, Quality Assurance
[][]To approve the Document
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/analog hygrometer and record in ‘Temperature, Relative Humidity (%) & Pressure Gradient Records’ (Annexure-I).
[][]Acceptance Criteria:
| Area | Temperature | Relative Humidity (%) |
|---|---|---|
| Dispensing, Material Staging, Dispensed Material Staging, D Corridor, Wash Bay, Clean Equipment, Broken Bulk, FBD Bag Store, Solution Preparation, Clean Equipment, Encapsulation, WIP Granules, WIP Tablet & Capsules, Coating, Tools Storage, Office Room, Coating Solution Preparation, D Dress Washing & Drying, Foil/Film Staging, Blister Packaging and Dry Syrup Filling & Sealing. | Not more than (NMT) 25°C | Not more than (NMT) 60 % |
| Granulation, Blending, Tablet Compression. | Not more than (NMT) 25°C | Not more than (NMT) 45% |
Pressure Gradient
[][]Read the pressure differential from magnehelic gauge provided and record.
[][]If the reading is not within limit, check whether all the doors are closed.
[][]Observe the second reading.
[][]Even if the second reading is not within the limit, inform the Engineering department for corrective action.
| Area | Pressure Differential |
|---|---|
| Processing Units Negative with respect to corridor (i.e. Air Flow is from corridor to processing unit) | 10 – 20 Pascal |
| Wash Bay Positive with respect to Corridor (i.e. Air Flow is from Wash Bay to Corridor) | 10 – 20 Pascal |
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 and take following steps in different areas.
[][]At Dispensing area stop weighing process, close the bags / high density polyethylene (HDPE) drums of raw materials.
[][]At Granulation area, stop transfer process of materials if running and close the SS / HDPE container with lid.
[][]Do not discharge if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Blending area, continue blending process if already running.
[][]At Compression area, stop operation and close the tablet SS/HDPE container lid. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Encapsulation area, stop operation and close the capsule SS/HDPE container lid. Do not keep the granules / pellets in the hopper during overnight. Empty the hopper and close the lid of SS/ HDPE container.
[][]At Coating area, continue operation if already running, otherwise stop operation. Do not unload if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Powder filling area, stop the operation. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Blister Packing area, close the lid of tablet / capsule container, close the hopper with lid and stop further operation.
Annexure:
Annexure I – Room Condition Monitoring Logbook