Whitehouse Laboratories announced that it 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 comprehensive evaluations of fittings for medical device and drug delivery systems. With this recent expansion, Whitehouse Labs becomes one of the only facilities in the United States 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,” commented 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.”
“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,” said Amanda Wohlleber, Whitehouse Labs general manager. “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.”
Whitehouse Labs, a division of Albany Molecular Research Inc., offers comprehensive analytical services providing support for manufacturing from development to market. From analytical chemistry and material qualification to packaging optimization, Whitehouse Laboratories serves pharmaceutical, biotechnology, medical device, life sciences, and consumer products organizations.
