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PyroButton Sterilization Process Management


Sterilization is a critical process in the safety and quality of products.

FDA's guidance for Sterilization Process Validation states, that "The efficacy of a given sterilization process for a specific drug product is evaluated on the basis of a series of protocols and scientific experiments designed to demonstrate that the sterilization process and associated control procedures can reproducibly deliver a sterile product."

"Guidance for the Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Products" issued by the US FDA in November, 1994, details the experimental and scientific information recommended to prove the validity of the sterilization process.

Opulus provides various levels of solution products based on PyroButton Self-powered data-loggers, communication systems, and integrated software to meet the requirement for Sterilization Process Validation, routine sterilization, maintenance, qualification, & re-qualification.


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