Pre-Validated Sterilization – BSTERILESM

BSTERILESM is a family of gamma and Ethylene Oxide (EtO) sterilization validations for different biorburden counts and types at different sterilization dosages and ranges.

If you decided to manufacture your product with our pre-qualified engineering resins, and your parts go through our validated manufacturing processes (CNC machining, injection molding, and associated secondary operations), you could use our BSTERILESM pre-validated sterilization data and be able to justify that a certain gamma radiation dose or EtO exposure will also sterilize your product as long as your bioburden counts and types are at or below our pre-validated tested value.

As a custom sterilization validation alternative, BSTERILESM can reduce sterilization development costs by over 30% and reduce development time by as much as 60%. (depending on the actual device and customer specifications)


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