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Complete Qualification Program

Our protocols are derived from years of experience and client-focused requirements. In addition to the standard Installation Qualification, Operational Qualification and Performance Qualification (IQ/OQ/PQ), Calvex will customize protocols for your specific requirements. The difference is the “Calvex Precision Execution”. Our methodical approach to protocol executions delivers your data correctly the first time, avoiding messy change controls and process delays.

Temperature & Humidity Mapping

Using the NEW Kaye Validator AVS, virtually any mapping scenario is possible. Calvex has conducted numerous mapping studies for temperature and humidity. We use the benefit of our experience and equipment capabilities to reap meaningful and usable mapping data for all CGMP environments. We’ve worked with the best labs in the country and they’ve trusted Calvex. The execution of our protocols integrates precision, each and every time.

Ultra-Low Temperature Freezers

Calvex offers a full range of services to maintain your ultra-low freezers. We understand the unique challenges that exist when repairing, calibrating and qualifying these low-temperature chambers. Using the Kaye LTR-90 Ultra-Low Temperature Reference Standard, we’re able to accurately calibrate our thermocouples and provide you with reliable mapping studies and reference data. Additionally, setting up reliable monitoring points, understanding defrost cycles and maintaining cascade refrigeration systems allows Calvex to greatly improve the operation and reliability of your ultra-low temperature chambers.

“They pay attention to everything, not just the stability equipment but the stability operation as a whole”

Stability Group Leader, Merck

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