Film Coating Technology
Datwyler, Middletown, DE, has developed a film coating technology for elastomeric closures for injectable drugs. 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 an innovative curing system not requiring any additional curing agents. The proven concept of a fluoropolymer film coating technology in combination with an ultra-low extractable rubber formulation forms a protective barrier reducing drug-stopper interaction to obtain the lowest level of extractables.
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