Crescent Medical Plastics, our clean room injection molding facility, operates under the ISO 13485:2003 certified procedures for medical device production. Our medical device manufacturing experience includes medical device housings, prenatal care, surgical implants, fixation devices, implantables, in-vitro diagnostics, emergency room products, CT&MR products, fluid delivery devices & containers, gastro products, cardiac products, women’s health care products, blood delivery housings, optical grade lenses and dental products.
Crescent’s clean room injection molding is completed in a certified ISO 8 or Class 100K clean room; we utilize scientific injection molding principles, state-of-the-art injection molding machines as well as automated quality inspection equipment. Our injection molding services include insert molding, over molding and family molding.
To provide our customers a single source solution, we offer ISO 7 or Class 10K clean room assembly and packaging services to complete your project. Assembly operations can be simple or complex, since we have the ability to build custom fixtures to aid in the assembly process. Examples of assembly procedures we employ are ultra sonic welding, UV bonding, adhesive bonding and heat staking.
Our clean room packaging includes a wide variety of products, kits, security and tamper evident seals utilizing procedures like vacuum heat sealing, Tyvek lid sealing, header and polybag sealing, vacuum formed tray packaging and other customer specific requirements.
To aid in the manufacturing process, we offer validation services including IQ, OQ and PQ, FAIRs, process flow charts, process control plans, process FMEAs, and capabilities studies. This ensures that a successful injection molding process is defined that will consistently manufacture parts to meet customer specifications.
We also make available design and development services and injection mold building services to provide you a complete manufacturing solution for your medical device components.