Pre-Validated Cleaning – BCLEANSM

How do you know your parts are clean and the entire manufacturing residue has been removed prior to final assembly?  Normally you would have to write a custom protocol, execute it, and send parts to a lab to determine cytotoxicity and bioburden levels and types.  At Biorep we have created a family of pre-validated cleaning protocols – BCLEANSM by using worst-case scenario parts that have undergone injection molding, CNC machining, and manual handling.  This means if you use one of pre-qualified engineering resins/materials and your part geometry is simpler than our test samples used for the validations, you could justify using our pre-validated BCLEANSM protocol. Most medical device components will be typically covered under one of our BCLEANSM pre-validated protocols.

As a custom cleaning validation alternative, BCLEANSM can reduce cleaning 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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