New England Electropolishing has a validated electropolishing line (full IQ, OQ PQ) dedicated to the processing of medical instruments and components.
NEE processes groups of components on other lines which are periodically tested by an independent laboratory for meeting the requirements of ASTM B912, “Standard Specification for Passivation of Stainless Steel Using Electropolishing,” and ASTM A967, “Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts.”
As an additional service to customers, NEE can verify process output by performing in-house Copper Sulfate Testing.
Process risk is evaluated via the use of Process Failure Mode Effects Analysis (PFMEA) methodology.
NEE welcomes the opportunity to work with Medical Device customers to provide tailored validation/verification activities in response to specific project requirements. Depending on the scope of the validation/verification activity, additional fees may apply. Please contact us to discuss.