Sterilization Process Development and Sterilization Validation 

Establishing the quality and safety of sterile products is imperative in pharmaceutical and biomedical applications.  Steam sterilization is a particularly challenging area for cGMP manufacturers and receives heavy scrutiny from regulatory agencies; improper sterilization can result in process failures, equipment downtime, and compromised products. 

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Through the NEXA CQV Sterilization Process Development & Validation Services, we provide process/cycle development and validation (PQ) for steam autoclaves, steam-in-place (SIP) of equipment, depyrogenation ovens, and chemical fumigation of rooms, isolators, and biosafety cabinets.  

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Our tried and tested approach minimizes the number of loads/runs required for initial PQ and provides a post-validation assessment tool that minimizes the revalidation required when new load items are introduced. Our work has been scrutinized by regulatory agencies on multiple occasions and has always passed with flying colors.

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Contact our team for a consultation to discuss your Sterilization Process Development and Sterilization Validation needs.