Installation, Operational, and Performance Qualifications (IQ, OQ, PQ) of environmental chambers are critical to effective process validations. At Bahnson Environmental Specialties (BES), we provide you with a thorough understanding of qualification protocols and will prepare, execute, and complete the qualification tests and present a comprehensive final report.
From centrifuges and autoclaves to warehouses, incubators, and more, our trained technical personnel are experienced in servicing and validating a wide range of equipment manufactured by both BES and our competitors.
Along with specialty knowledge of the pharmaceutical, research, and product testing industries, our technicians also have in-depth electrical and mechanical backgrounds. This training provides you with outstanding hands-on expertise for the qualification of your stability chamber.
Our team can generate a standard protocol, customize one to your specific requirements, or execute your protocols and follow your standard operating procedures. Whichever you choose, you’ll know your equipment is operating according to the most exacting specifications.
We establish that the equipment is properly and safely installed. All model and serial numbers are verified and recorded, and all utility requirements are documented.
We establish that the chamber consistently meets design specifications by demonstrating performance in unloaded conditions. Temperature and relative humidity uniformities are verified using thermocouple and relative humidity (RH) sensors.
We establish that the chamber consistently meets performance specifications in loaded conditions. This test is generally performed at the chamber’s operating set point and a simulated product load is used to replicate typical product storage. Temperature and relative humidity uniformities are verified using thermocouple and RH sensors.
We review all collected test data with the customer for completeness and accuracy. The original data is retained by the customer and the multi-point data is transferred to the final report and presented in graphical form. All other information is written within the text and included in the final report.
To help expedite validation, we can perform OQ of chambers prior to shipment. All documentation meets cGMP requirements and can be used as part of IQ. As a result, a significant portion of the validation process is completed in our factory, dramatically reducing the time it takes to commission chambers once they arrive on site.