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When a standard item won’t cut it, our team of experts will ask the right questions to design and manufacture a custom solution.
Medical device components must perform reliably and consistently to ensure patient safety and product efficacy. We have been consistently delivering on these requirements for over 50 years.
We possess advanced engineering capabilities and state-of-the-art equipment to produce components with high accuracy and reliability.
Extensive experience processing USP Class VI resins that have been tested and pass stringent bio-compatibility requirements. There is a wide variety of commercially available Class VI resins to meet specific applications of strength, compatibility, autoclavability, clarity and more, including but not limited to HDPE, PP, PETG, PC, PEEK, and more.
Our consistent adherence to stringent quality standards is paramount to ensure the safety and effectiveness of the components we produce.
Compliance with your specifications and regulatory bodies such as the FDA (Food and Drug Administration) in the United States or CE (Conformité Européenne) marking in Europe is non-negotiable. We must have robust processes in place to meet regulatory standards and obtain necessary certifications.
Traceability of material lots and processes is essential for quality assurance and regulatory compliance. Our Quality Assurance team maintains comprehensive documentation throughout the production process to ensure transparency and accountability.
Building strong partnerships with our clients fosters collaboration and communication throughout the manufacturing process. Our team is responsive to your needs, and will provide support and guidance from design to production and beyond.
The medical device industry is continually evolving, with advancements in technology and regulatory requirements. We prioritize ongoing improvement initiatives to stay abreast of industry developments and consistently invest in ongoing improvements to remain at the leading edge of capabilities.
Not all bottles are created equal. We have been serving the medical and laboratory markets for over 50 years. We understand the requirements, demands, and intricacies — everything from PFMEA to particulates.
Do you have clean room capabilities?
Yes! We have multiple portable Class 8 clean rooms that can be used with any of our production lines. We also have a permanent white room controlled manufacturing room.
Can you manufacture product in 100% virgin plastic?
Absolutely. Our closed loop automated material handling systems can handle anything from 100% virgin to precise, custom blends of up to 4 components, including colorant, regrind, and additives.
Are your products made in a GMP-compliant facility?
Yes, we follow GMP requirements and all of our employees are trained on properly following established processes and procedures.
Can you process products that can be sterilized?
Yes, we are experts in processing polycarbonate, polysulfone, and Ultem. These resins can be autoclaved at third parties for sterilization.
