Regulated Manufacturing: Accessing Polymers Just Got Easier
LyndonellBasell — one of the world’s largest producers of polymers — has expanded its Purell medical-grade polymer portfolio into the North American market. This move will give North American healthcare and medical device manufacturers better access to high-quality polymer materials.
Medical-grade polymers play a critical role in healthcare, supporting applications ranging from single-use products to long-term implants. For example, polymers are commonly found in lab equipment, insulin pens, IV lines, prosthetics and pharmaceutical packaging.
The expansion will strengthen North American healthcare supply chain reliability and material quality. The Purell line offers features like stringent quality controls, material traceability and a two-year change notification commitment for voluntary material changes.
Material access and regulatory risk are inseparable for regulated manufacturers. A polymer change may require revalidation, documentation updates, supplier audits and regulatory submissions. Therefore, traceability and two-year change notification programs like Purell’s prevent surprise disruptions that might delay production or compromise compliance.
With ASG teams in the U.S. and Europe, we’re well-positioned to support regulated manufacturers in ensuring their devices meet the highest standards for safety, reliability and user experience. “We have years of experience within medical device design, development and commercialization,” said Jason McGlynn, ASG Europe director and general manager. “ASG accelerates our clients’ speed to market by providing industry experience and quality test services,” Jason said.
At ASG, we can help you ensure your devices meet regulatory standards and get delivered on time. Contact us to explore the possibilities.
