Establishing Proper Validation of Extruded Silicone Tubing
Medical device manufacturers understand that contract manufacturers are experts in their manufacturing discipline. That said, as medical device OEMs respond to the current requirements described in the European Medical Device Regulation (EU MDR) or by the Food and Drug Administration (FDA), the topic of process validation is more common.
Most OEMs simply don't have a validation plan for a contract manufacturer to follow. This article
presents a program that moves projects from the process development phase of manufacturing to
a fully validated process. It provides a comprehensive overview of the validation process for extruded silicone tubing and includes detailed guidance on qualifying manufacturing equipment and offers a structured framework for process validation. Furthermore, it explains the mathematical analysis
required to confirm process control, emphasizing sampling strategies to accurately achieve a CpK value of 1.33 or higher.
Along with this article, listen to Paul Mazelin, Founder and President of SiMEDEx, discuss the benefits of early collaboration with your outsourcing partner. SiMEDEx is a trusted partner for developmental products, combining deep technical expertise with exceptional responsiveness. Additionally, SiMEDEx works collaboratively with customers to address inflationary challenges through targeted cost-reduction initiatives.
Complete the form and access our informative article on how to perform a validation of an extruded (silicone) tube, as well as our President's message.
