Whitehouse Laboratories has expanded its drug delivery device testing capabilities to encompass the full series of ISO 80369 standard test procedures. The ISO 80369 series of eight test standards provides evaluations of fittings for medical device and drug delivery systems. With this recent expansion, Whitehouse Labs says it is one of the only facilities in the U.S. to provide 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,” said Mark Stier, vice president, global analytical sales and business development. “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.”

Amanda Wohlleber, general manager, Whitehouse Labs, said, “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. 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.”