Datwyler, a provider of high-quality, system-critical elastomer components, is launching UltraShield at Interphex Booth 1237, April 25, 2023 – April 27. The company has developed its own film coating technology, offering both film and spray fluoropolymer coating technologies for elastomeric closures for injectable drugs. This extended range of coating options is designed to meet the highest demands for quality and performance for large and sensitive molecule drugs, allowing Datwyler to respond even better to specific applications and customer preferences.
 
“We want to become the most valued partner for parenteral packaging to the pharmaceutical industry by offering best-in-class products with a strong presence in new drug developments while leveraging our FirstLine production standard and state-of-the-art global footprint,” said Dirk Borghs, CEO Datwyler Healthcare.
 
The concept of a fluoropolymer film coating technology in combination with Datwyler’s ultra-low extractable rubber formulation forms a protective barrier reducing drug-stopper interaction to obtain the lowest level of extractables, according to the company. The chemical and functional characteristics of UltraShield have been specifically designed to securely store drugs under ultra-low temperatures up to -80°C and to provide compatibility with modern solvent-based drug excipients. The lubrication of the non-drug contact part of the stopper is fixed with a curing system not requiring any additional curing agents. According to the company, this results in flawless machineability while offering best-in-class subvisible particle levels and optimal chemical performance.
 
UltraShield is manufactured according to Datwyler’s FirstLine concept. This standard is an advanced manufacturing concept for high-quality elastomer components for the healthcare industry with state-of-the-art clean room technology, automatic production cells, fully automatic camera inspection and a unique washing process.
 
“With best-in-class extractable and leachable profiles and the highest quality standards, both UltraShield and OmniFlex have a unique set of value-added features that makes them complementary in addressing any of our customers’ needs with the ultimate solution,” said Geert Moens, Global Platform Leader, Vial Closure Systems.