Smithers has invested in a state-of-the-art ICP-MS (inductively coupled plasma mass spectrometry) instrument at its analytical services laboratory in Akron, Ohio.
ICP-MS is used for detecting and measuring elemental impurities in packaging components and container/closure systems as part of extractables and leachables
studies. ICP-MS is also the key analytical technique for testing pharmaceuticals for elemental impurities as required under United States Pharmacopeia <232> which was implemented last year. Elemental impurities can come from processing equipment or container closure systems during the production and packaging processes in pharmaceutical manufacturing. Elemental impurities have the potential to have a significant impact on the integrity of the final drug product and so must be carefully monitored.
“This new instrument is highly sensitive and can detect extremely low levels of elements that may be of concern in a given product,” said Paul Cummings
, general manager of the lab. “FDA requirements for this type of testing and a dynamic, changing industry will require more support for pharmaceutical manufacturers going forward. We’re very pleased to continue to increase the value we bring to our customers in developing better drug products and successfully bringing them to the people who depend on these medicines to improve their quality of life.”
Smithers’ analytical services laboratory in Akron, Ohio, opened its doors
in July of 2017 and conducts various chemistry studies, such as extractables and leachables
, supporting primarily the medical device
, and packaging
industries. This site combines with its sister lab in the United Kingdom to provide clients with high-quality, state-of-the-art analytical testing and consulting services.
“With this investment, Smithers now offers elemental analysis in both the United States and the United Kingdom,” said Nat Leonard, Group President, Life Sciences, Smithers. “Both our laboratories are equipped with the instrumentation and expertise to provide a full suite of analytical services to our clients on a global level.”