Installation, operational, and performance qualifications of stability chambers are critical to effective process validations. We provides you with a thorough understanding of qualification protocols and will prepare, execute and complete the qualification tests and present a comprehensive Final Report.
Our trained technical personnel are experienced in servicing and validating pharmaceutical equipment, with an added benefit of having in-depth electrical and mechanical backgrounds. This training provides you with the best hands-on capabilities for the qualification of your stability chamber. Like our preventive maintenance/calibration programs, we can customize your protocol for the qualifications of our and competitive equipment.
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 performance specifications by demonstrating various operating set points at unloaded conditions. Temperature and relative humidity uniformities are verified using thermocouple and RH sensors.
We establish that the chamber consistently meets performance specifications by demonstrating various operating set points at 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 Fiona Report and presented in graphical form. All other information is written within the text and included in the Final Report.
We appreciate your business!
Our service professionals are prompt, knowledgeable and courteous. We will work with you and your staff to maintain a positive working relationship and to make your experience with ES a pleasant one!