Medical Molding - Sterilization Cases and Trays
Molding and Assembly
For implantables and durable and disposable medical devices, the quality process begins with the receipt of the order.
- Verification of Design for Manufacturability (DFM) based on part concept and specification
- Tooling and process capability studies
- Verification process consisting of IQ, OQ, and PQ
- Cross-functional teams to evaluate potential savings
- Multi-shot and spin stack molding for improved productivity and part design
- Molding and assembly in a Certified ISO 13485 environment
- Molding and assembly in certified ISO Class 8 Clean Room (Class 100,000)
- Molding in Certified ISO Class 7 Mini-environment
- Clean room certified to ISO-14698 for biocontamination control
- Clean room certified to ISO-14644 for airborne particulate concentration
- Class 100,000 clean room assembly
- cGMP compliant
- Process validation and lot traceability
- Packaging and labeling including bar coding
- Experienced in processing PEEK, polysulfone, Delrin®, Ultem, Tecothane®, LCPs, TPEs, Xenoy, Lexan®, HPS1, and other demanding medical materials.
- Qualification, documentation, and traceability at the highest level of compliance
- Part size ranging from micro-molding to 100 square inches
- Decorative hot stamping, pad printing, labeling, sonic welding, in-mold labeling, and other value-added secondary operations.
- Packaging including validated sterile barrier
- Bar coding
Metal Stamping and Fabrication (sterilization cases and trays)
Our processes combine plastics and metal technical expertise, cross functional teams, and rigid standards.
- Hybrid designs, single or multilevel cases, stackable trays, stackable cases, caddies and nests.
- CAD/CAM from your concept of DFM from your print
- Prototyping
- Laser cutting for airflow of any design, even through-metal logos
- Plastic injection molding for corners, lids, grippers, and feet
- Waterjet cutting for silicone and EPDM
- Nylon coating
- Anodizing
- Silk screening
- stainless steel
- Anodized aluminum
- Propylux® polypropylene for repeated steam sterilization and abrasion resistance; FDA approved
Please view our web site at:
Plastic Medical Molding & Assembly
Please scroll through the following 2 embedded PDF files to learn more about our capabilities