A clean room environment helps ensure that particles that don’t belong in the molded part are kept out i.e. hair, skin, dirt, paper fibers or other particulates. Given the increasing scrutiny of the FDA and other regulating bodies, many OEM’s are opting for molding to happen in a clean room as an additional safeguard. Crescent consistently produces superior plastic components and medical device assemblies in our clean room, watch our video.
We are FDA Registered and ISO 13485 certified. We perform initial sampling to document part sizes, appearance and function plus perform final sampling with documentation to obtain approval for production. We will develop and initiate a validation protocol that meets your project requirements.
Our engineers have over 100+ years of combined injection molding experience to help in the early stages of your project with guidance for part design, knowledge of medical grade materials and implantable thermoplastics and mold design to ensure production optimization.
We manufacture class I, II & III medical devices and components in our ISO 8 (100K) clean room facility including medical device housings, prenantal care, surgical implants, in-vitro diagnostics, emergency room products, CT&MR products, fluid delivery devices and containers, gastro products, cardiac products, women’s health care products, blood delivery housings, optical grade lenses, dental products, ear, nose and throat products, orthopedics, labware, centrifuge products, catheter and cannula products.
Crescent also offersISO 7 (10K) clean room contract assembly and packaging utilizing automation and skilled labor to complete your project.