At Biomedical Polymers, we manufacture highly precise plastic consumables for Medical Device research and medical diagnostics. Our injection blow molding process can meet critical OEM standards for Class 1 medical devices. We can also produce a variety of containers using formulated polymers that can meet virtually any application requirement for major diagnostic companies.
In the project highlighted here, 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 1 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 a timeframe of 10 days. To meet these standards, we configured a set of unique tooling and designed a specialized production process; allowing us to achieve very low residuals and leachables. The 500 ml bottle was produced using our 85-ton Jomar injection blow molding machine, and the cap was produced on a 135 ton injection molding machine. This highly precise method yielded dimensional tolerances as tight as +0.005”. We used USP Grade VI Polypropylene; employing a zero release agent chemical treatment that prevented material bonding to the container’s A1 surface finish. To ensure that we met the exact specifications for our customer’s upcoming 510K filing, each bottle was subjected to a rigorous dimensional and leak testing regimen.
Our customer was extremely pleased with our commitment to quality and our ability to work toward a viable product that met all stringent Class 1 medical device standards. It highlighted our ability to act as a single source provider for our customer. We produced a total of 400,000 bottles and caps within an extremely tight deadline. Today, we continue to work with this customer on new product designs. For more information on our injection blow molding capabilities for the medical industry, please contact us or refer to the table below.
- Project Name & Description: 500 mL square reagent container
- Capabilities Applied/Processes: Injection blow molding, zero release agent
- Equipment Used to Manufacture Part: 85 Ton Jomar Injection Blow Molding machine
- Overall Part Dimensions: 500 mL container
- Tightest Tolerances: ±0.005″
- Material Used: USP Grade VI Polypropylene
- Material Finish: A1
- Industry for Use: Clinical diagnostics
- In Process Testing/Inspection Performed: Dimensional and leak testing
- Volume: 400 K
- Delivery/Turnaround Time: 10 days
- Standards Met: Class 1 medical device