Process Validation for
Medical Device Coatings

Process Validation


Once a manufacturing process is designed and built, it must be validated in order to meet Good Manufacturing Process (GMP) standards. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and products. Biocoat has access to experts in the area of Process Validation and can help you towards commercialization of a coated product.

Validating a Coating Process


Not only must the equipment used to coat devices work consistently, but the medical device manufactured must also be of consistent quality and perform to specification. As with any manufacturing process, conditions in the environment or human factors can vary and this can affect product quality. Before commercialization, it is important to discern and mitigate as many of these risks as possible. Depending on your regulatory requirements, Biocoat can craft a Process Validation protocol that is robust and defendable.

What Does Process Validation Include?

Although every new coating process will have a customized set of validation tests, common possibilities are:

• Limit testing for the curing process
• Limit testing for coating thickness
• Consistent outcomes for biocompatibility
• Risk analysis for process deviations
• Limit testing for post-processing, such as sterilization
• Validation of SOP’s