Move spurred by rise in demand for classification and testing requirements for packaging components
Whitehouse Laboratories, a division of AMRI, announces that it has increased its testing resources dedicated to U.S. Pharmacopeia (USP) Chapters 661.1 and 661.2 for packaging component qualification due to client demand.
According to these USP chapters, all primary packaging components and some secondary packaging components must comply with the applicable standards, USP 661.1, 661.2, 660, 670, and/or 381. Whitehouse Laboratories is also testing several clients’ associated packaging components, such as spoons, dosing cups, and dosing syringes, for dosing accuracy, as well as per the relevant USP chapters.
While many companies have been qualifying their containers and container closure systems in accordance with the requirements of USP chapters 661.1 and 661.2, the systems tested often omit some primary, secondary, and/or associated packaging components as defined in USP chapter 659, such as desiccant canisters and sachets which come into direct contact with the packaged product. Depending on the risk and product category, testing considerations may include identification, infrared spectrophotometry, thermal analysis, extractables and leachables, plastic additives, physicochemical tests, metals, elemental analysis, bioburden, and biological reactivity.
“With an ever-expanding expert team and knowledge base, Whitehouse Laboratories is the premier source for container closure packaging system qualification,” said Amanda Wohlleber, general manager at Whitehouse Laboratories. “In order to keep up with the increased demand for testing services, we have added expertise and increased capacity in the applicable testing areas – including 661.1, 661.2, 381, 87, 88, 660, 670 – specifically regarding additional associated packaging components.”
About Whitehouse Laboratories
A leader in analytical testing, Whitehouse Laboratories, a division of AMRI, offers comprehensive analytical services providing support for manufacturing from development to market. From analytical chemistry and material qualification to packaging optimization, Whitehouse Laboratories is the testing partner for the world’s leading Pharmaceutical, Biotechnology, Medical Device, Life Sciences and Consumer Products organizations.
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product.