calibration and validation of stability chamber
Calibration and Validation of Stability Chamber
i) Calibration
• Temperature sensor probe calibration with traceability to ERTL
• Temperature controller calibration with traceability to ERTL
ii) Validation
• IQ, OQ and PQ documentation and protocols shall be provided with equipment.
• Documentation prepared / developed for Meditech Technologies India Pvt Ltd. – Ireland, one of Europe’s leading validation
consultants leading validation consultants
• Performance Qualification with Temperature Mapping on site. The Performance Validation Test consists of one cycle at any
one temperature point for an 8-hour period. Data is collected in printed format from up to six different points within the chamber.
Temperature uniformity is considered acceptable if the deviation is less than ±1°C of set temperature.
i) Calibration
• Temperature sensor probe calibration with traceability to ERTL
• Temperature controller calibration with traceability to ERTL
ii) Validation
• IQ, OQ and PQ documentation and protocols shall be provided with equipment.
• Documentation prepared / developed for Meditech Technologies India Pvt Ltd. – Ireland, one of Europe’s leading validation
consultants leading validation consultants
• Performance Qualification with Temperature Mapping on site. The Performance Validation Test consists of one cycle at any
one temperature point for an 8-hour period. Data is collected in printed format from up to six different points within the chamber.
Temperature uniformity is considered acceptable if the deviation is less than ±1°C of set temperature.
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