Controlled Temperature Units i.e. Fridges, Freezers, Incubators or Coldroom are most commonly used in pharmaceutical or biopharmaceutical industries to store medicinal products, intermediates or raw materials as per the recommended storage conditions and also for the manufacturing process. Highly regulated industries require to qualify and validate these units to verify their capability of storing products or running process that do not compromise products quality or shelf life. The purpose of this article is to summarize the general industry practices and regulatory requirements/guidelines for the qualification or validation activities performed that ensure that CTUs can be used routinely to meet the user requirements and to maintain product integrity and quality.
The qualification and validation of CTU's consists of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Basic Installation check is performed, i.e. make and model check, location verification, CE mark verification etc. as well as verification as per specific user requirements stated to User Requirements Specification (URS) document.
Operational Qualification of CTU's are consists of following tastings in general:
-Calibration Verification of EMS (Environmental Monitoring System) logger, external data loggers
-Procedure verification
-Maintenance verification i.e. Equipment is on Maintenance schedule
-Alarm Functionality checks
-24 hours empty chamber temperature mapping (An assessment to be performed based on the size of the chamber/area to be mapped with regards to number and location of data loggers required. For guidance refer to ISPE Good Practice Guide, Controlled Temperature Chambers). Worst case location is identified based on empty chamber mapping and EMS probe is placed for routine monitoring.
-Power Failure Testing
-Open door study and recovery testing i.e. EMS alert limit and alarm limit can be set based on the study and the assessment of products to be stored
-Defrost Cycle verification i.e. only applicable to Fridges and Freezers where they have manual defrost cycle that is not part of the automatic operation
-24 hours full load testing (System user should defined the load following guidance of the vendor and Standard Operating Procedure of CTUs)
Performance Qualification:
Performance Qualification can be covered by worst case full load testing performed in the Operational Qualification and hence, some companies do not perform separate PQ. Furthermore, the requalification of CTUs are also performed for temperature verification on 'As found' load to verify the integrity of validated state. A risk assessment is generally performed to define the Requalification frequency of CTUs.
This is the overall approach of the qualification and validation of Controlled Temperature Units so far I have come across. Warehouse is out of scope of this article and validation approach will be different which can be addressed in separate topic. Feel free put your comment and opinions.
References:
ISPE Good Practice Guide
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