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Cleanroom Injection Molding

As cleanroom manufacturers, we conduct all manufacturing in a regularly audited, certified Class 8 cleanroom. This is for our customers that demand a high level of material handling and packaging to maintain product integrity. All products are treated as if they are sterile products; strict gowning and gloving procedures to minimize any possible contamination. Several products are certified RNase/DNase free including one for PCR test kits.

Injection Blow Molding

We used a Jomar 85S injection blow molding machine to produce 65,000+ 500mL centrifuge bottles for a biopharmaceutical application. We also supplied a closure with a platinum-cured O-ring to increase seal integrity. Double bagged, sent out for sterilization, and tested for particulate and endotoxin certifications. Our skilled team manufactured the polypropylene part; weighs approximately 55.5 grams, to +.005″/-.000″ tolerances.

Injection Blow Molded Reagent Container

We were asked to provide complete sourcing and manufacturing for a 500 mL square reagent container that would be incorporated into a clinical diagnostic test kit. The container had to meet exact customer specifications for Class I approval. This was not an ordinary off-the-shelf part nor was it available on the open market. It required our team to conduct full design, manufacturing, and quality control under one roof within 10 days.

Process Validation

A customer in the medical device industry required process validation for an extremely complex device using an intricate mold design.

Industry experts in validation services for the medical industry, our team was challenged to analyze production specifications using our injection molding system and robot-assisted part removal process. The results required in-house production, stringent quality control and validation capabilities.