Class I, II and III medical devices, which include products like medical device housings, surgical instruments, implantables, emergency room products, fluid delivery devices and containers,cardiac products, blood delivery products, pediatric devices, in vitro diagnostics, medical imaging, obesity treatment devices, optical grade lenses, pharmaceutical and dental products, need a specific type of injection molder. Partnering with an injection molder experienced in medical device manufacturing and clean room manufacturing is a must. Because a primary requirement for medical and clean room injection molding are the quality operational controls. FDA registration and/or ISO 13485 certification is required to maintain these quality systems operational standards.
Choosing the Right Injection Molder
For medical and clean room injection molded productscountless tasks must be undertaken and requirements met to produce safe, reliable and quality medical components and devices. For a medical device manufacturer, a clean room injection molder could be an ideal sourcing option. For example, utilizing the injection molder's specialized skills like design for manufacturing to build a more efficient and optimized injection mold, especially if this mold will be manufacturing product in a clean room. Designers need to consider limiting the amount of friction, the use of lubricants and eliminate the need for spray release agents during de-molding.
Injection molders experienced with medical applications have a thorough knowledge of medical grade materials and implantable thermoplastics to ensure manufacturability, as well as part function.
Clean room medical manufacturing operations and management can be an industrious challenge. Countless tasks must be undertaken and numerous requirements must be met. Clean room injection molding, assembly and packaging areas require a steady maintained level of particulate control from the effects of dust, chemical vapors, aerosol particles and airborne microbes. Cleanliness is not only essential, but regulated very specifically. It must adhere to strict medical manufacturing protocols either under ISO 13485 or/and FDA. A certified ISO 7 clean room is 10,000 pollution particles per cubic meter or foot and ISO 8 clean room is 100,000 particles per cubic meter or foot. The type of clean room needed depends on the specific requirements of the product or use.
Safety and quality standards of products are of utmost concern to maintain your accreditation and reputation, so choosing a medical or clean room manufacturing with the proper quality standards is critical. Your injection molder should be able to provide process validation, PFMEA, control plans and capability studies. This is important because they are the necessary requirements for medical device manufacturing to meet all the regulatory, quality and commercial standards that the FDA requires. As well as providing the necessary information to help you achieve 510K approval for your product.
FDA Registration and ISO 13485 Certification
Quality control systems required for medical device manufactures means being FDA registered and/or ISO 13485 certified. This quality certification emphasizes documentation to verify procedures that provide controlled conditions. These are the activities and process required to manufacture a product. These requirements involve work environment controls, risk management activities required during product development and special inspection, as well as lot traceability requirements from raw materials through production.
Any company involved in the production and distribution of medical devices or components intended for commercial distribution in the United States are required to obtain an FDA registration. This registration is complete once the Quality Management System is in compliance with the rules established under FDA Quality System Regulation (QSR) as established under the 21 Code of Federal Regulation (CFR) Part 820 (Medical Devices).
If you are in need of a qualified medical injection molder, Crescent Industries is FDA and ISO 13845:2003 certified that operates a Class 100k clean room for injection molding and a class 10K for assembly and packaging operations. We understand excellent standards, trust and quality components are necessary for your project.