Sterilization Process Development and Sterilization Validation from Transcat

Establishing the quality and safety of sterile products is imperative in pharmaceutical and biomedical applications.   
One of the most challenging areas for cGMP manufacturers is steam sterilization. This is an area that receives heavy scrutiny from regulatory agencies and with good reason: improper sterilization can result in process failures, equipment downtime, and compromised products. 

Benefits of Working with Transcat

Transcat can help you ensure quality, safety, and efficiency by creating custom sterilization processes unique to your needs.  CQV services from Transcat can help streamline operations, reduce downtime, and improve overall productivity. Clients trust our experienced team to help implement rigorous CQV procedures that minimize the risk of product contamination, equipment malfunctions, and other hazards that could compromise quality and safety.

Transcat’s CQV Sterilization Process Development & Validation Services include rocess/cycle development and validation (PQ) for: 

• Steam autoclaves 
• Steam-in-place (SIP) of equipment 
• Depyrogenation ovens

As well as chemical fumigation of rooms, isolators, and biosafety cabinets.

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. 

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