Process Validation for Medical Device Coatings

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 product. Biocoat has access to experts in the area of Process Validation and can help you along your pathway towards commercialization of a coated product.

Validating a Coating Process

Not only must the equipment used to coat devices work consistently as designed, the product manufactured by the process 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.

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
• Consistent outcomes for biocompatibility
• Limit testing for coating thickness
• Limit testing for coating solution formulation
• Risk analysis for process deviations
• Limit testing for post-processing, such as washing or sterilization
• Validation of SOP's

The Biocoat Advantage

By working with Biocoat, a client gains a partner in coating commercialization. Specialized and focused experience in the area of medical device coatings is brought to bear. This knowledge can be used to supplement the research of a client's own scientific staff, or it can act as the main development house for the coating component. With 20 years of experience in creating medical device coatings, Biocoat is a trusted agent for medical device coatings commercialization.