Whitehouse Laboratories, a division of Albany Molecular Research, said today that it has expanded its drug delivery device testing capabilities to include services for ISO 80369 standards.
The 8 standards described in ISO 80369 were designed to prevent connector errors in medical device and drug delivery systems. Whitehouse Labs said that the group’s latest expansion helps to position itself as one of the only places in the U.S. to offer compliance testing services for these standards.
“At the end of 2016, a full gamut of specifications and performance test methods were published by ISO to reduce the risk of misconnecting fittings in medical procedures. Through the design of connectors for specific procedures and applications, it is now very difficult for healthcare providers to physically connect delivery devices from one procedure to the next,” Mark Stier, VP of global analytical sales & business development, said in prepared remarks. “To meet the drug delivery device industry’s demand for testing of new fittings, Whitehouse Laboratories is now fully equipped to cover all eight standards with the required gauges and reference fittings to evaluate compliance to this series of test requirements and implement the latest standards in response to regulatory and customer demands.”
“We will be delivering high precision compliance data under the well-established name and testing capabilities that Whitehouse Labs has provided for the medical device and pharmaceutical container closure industries,” Amanda Wohlleber, Whitehouse Labs GM, added. “With this testing capability, Whitehouse Labs has now created a ‘state-of-the-art’ workstation for drug delivery devices for compliance testing to the ISO 80369 series of standards.”
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.