At its core, validation is simply proof that a technology works as intended and does so consistently. Of course, the actual process of product validation is anything but simple. In fact, it is a very methodical process that requires strict documentation of procedures throughout the course of design and manufacturing of new products. Validation is, however, a necessary process that builds trust in our products and in yours.
While the importance of validation increases with the risk associated with device failure, product manufacturers in all industries want to be confident in the parts they are specifying. That’s why at CPC, we validate our couplings and connectors to a single standard — the highest. We don’t do it because of regulations or mandates, we do it to ensure our products exceed your expectations for quality and conformity.
At CPC, all of our new products are produced within the ISO 13485 quality system. This standard is related to medical devices, but since it has additional requirements beyond what is specified in ISO 9001, to us it represents the gold standard which is used for every new product. Complying with ISO 13485 also allows makers of bioprocessing, IVD and surgical devices to specify CPC products with confidence.
Our commitment to validation is part of a foundational belief in rigor. We always want to exceed the most demanding standards. Our engineers leverage solid modeling capabilities and cutting-edge prototyping equipment to evaluate the performance of every design before our products ever reach your application. Additionally, your custom solution can benefit from extensive testing and validation to ensure product performance that is based on risk assessments performed under ISO 13485 —streamlining your approval process and allowing you to reach the market faster, with less work. This helps build a powerful feedback loop of confidence from our customers — the more they trust our products, the harder we work to continue to earn that trust.
Our validation packages summarize our robust testing requirements so you can be assured of the robustness of our products. During product development, each product is rigorously tested. This ensures the quality of every coupling and connector.
CPC test capabilities include:
· Helium mass spectrometer leak testing
· Surfactant in water leak testing
· Repetitive connect/disconnect cycle testing
· Repetitive pressurization cycle testing
· Hydraulic burst testing at ambient or elevated temperatures
· Leak under load testing
· Force/Torque to break testing
· Force/Torque to connect/disconnect
· Fluid spillage and air inclusion testing
· Flow rate testing
· Biocompatibility testing (USP Class 6 & ISO 10993)
· Time at temperature/accelerated aging
· Sterilization compatibility
· Bacterial challenge testing
· Microbial ingress testing
Our rigor extends to studying the shelf life of our quick disconnect couplings and connections. Because they are made from a variety of metal, plastic and elastomeric raw materials, their shelf life is dependent upon those materials and the storage conditions. When storing any CPC product in the recommended environment (shielded from light at temperatures between 50ºF and 90ºF) the shelf life of CPC couplings and connectors is estimated to be three years from the date of manufacture.
If you have any further questions about the CPC validation process or any CPC product, please complete the form, and a CPC representative will contact you.