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The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.
Stevanato Group, an Italian glass primary packaging and provider, and Nelson Laboratories, a lab testing and advisory services company, announced on Sept. 2, 2020 that they have signed a partnership agreement to provide extractables and leachables (E&L) testing at the SG US Technology Excellence Center (TEC) in Boston, MA.
The SG US TEC, which is opening on Sept. 24, 2020, will offer analytical services on material properties, and physical and mechanical performances to pinpoint the interactions between drugs and glass-based primary packaging, a Stevanato press release said. Nelson Labs will provide the TEC with toxicological evaluation, biocompatibility, microbiology, and E&L testing through the agreement.
“With our laboratory in Italy, SG Lab, we have collaborated for many years with Nelson Labs’ European Center of Excellence, Nelson Labs,” Stevanato said in the press release. “We are glad to extend this collaboration also to our US customers. Its recognized expertise in extractables and leachables testing applied to biologics is crucial to ensure that the packaging system does not adulterate the drug product, ensuring drug efficacy, and patient safety.”
“Combining SG US TEC skilled scientists with Nelson Labs’ experts and cutting-edge laboratory capabilities, we can now offer comprehensive analytical services assessing drug compatibility with container closure systems and devices/combination products,” added Abizer Harianawala, site leader at US TEC, in the press release. “When it comes to the E&L qualification process of the primary packaging, biologics face additional challenges compared to small-molecule drugs.”