Is Chamber Qualification more complicated than we think?

The qualification of controlled temperature chambers presents a contradictory challenge to the validation technician: while each chamber qualification follows a relatively simple framework, the nuances of different chambers, manufacturers, temperature set points, alarms, automation systems, refrigeration and heating systems, and various other peripheral components often require highly individualized methodologies, thus revealing a deceptive level of complexity in the task. Although, in the most general terms, a chamber is only required to maintain uniform environmental conditions within given process limits, few owners require so little of their equipment, particularly in highly regulated workspaces. Even when the control is limited to temperature regulation, the individual nature of each chamber becomes apparent through qualification studies. Temperature stabilization and recovery periods vary widely across different refrigeration and heating systems, which can present a multitude of problems during mandatory temperature uniformity studies. Defrost cycles occurring automatically within a cold chamber can often cause unpredictable temperature spikes outside of process range, negatively impacting product stability within the chamber. Certain control systems allow for several hours of temperature fluctuation after the chamber is opened before returning to process levels, and others will overcompensate for large changes in temperature, requiring careful observation before a qualification study can be started. Further, control systems that behave in one way at a specified set point may behave in an entirely separate way if the set point is adjusted, even if no changes are made to the control system itself. With such variation between chambers, it is impossible at the onset of qualification for the technician to predict everything that might occur during temperature mapping. Beyond the mechanical controls of the chamber, the safety features equipped to each unit require further analysis to ensure that, in the event of equipment failure, the chamber will respond properly to the emergency condition and resume operation as normal once the fault is cleared. Building automation systems present a second level of convolution on top of the local alarm system, requiring a full test of all relays to ensure that each signal is transmitted properly to the monitoring software. Even further, when the local alarm and remote alarm systems are independent of one another, any additional temperature probes must be individually calibrated and proven to function as required. Like temperature uniformity testing, there is no hard-and-fast blueprint for the technician to prove the functionality of chamber alarm systems; only guidelines and general knowledge of how to meet certain requirements placed on the chamber. Azzur Group, LLC is a lifesciences consulting firm Understanding the diverse nature of controlled temperature chambers, it is specializing in Mechanical C&Q, our firm belief that the value of our technicians lies in their ability to quickly Computer System Validation, adapt to the individual operation of each chamber, effectively identifying Audit and Compliance, and and avoiding roadblocks in the qualification process while meeting both Business Process Improvement. regulations and the highest quality standards. Our technicians are at their best when they apply their knowledge of chamber qualification procedures to the specifics of the chamber qualification at hand, and not the other way Azzur Group, LLC around, ensuring that your qualification package will only be considered 726 Fitzwatertown, Rd. Willow complete when it rises to all of your expectations. Grove, PA 19090 1-215-322-8322 info@azzurgroup.com www.azzurgroup.com