Brochure
OmniFlex®
The unique spray coating solution engineered to protect highly sensitive drugs with uncompromising purity and global supply certainty.
Status
Published
Format
Brochure
Language
English
Access
Registration Required
Resource Overview
About this Brochure
OmniFlex® is Datwyler's best-in-class coated stopper solution for sensitive biologics, injectable drugs, and lyophilized formulations. Its proprietary fluoropolymer coating is bonded to ultra-clean FM457 bromobutyl rubber, forming a full protective barrier that minimizes drug–component interactions and delivers the lowest extractables and leachables on the market. The total-coverage coating prevents rubber shedding and eliminates the need for silicone oil, significantly reducing particulate contamination risk. A specially coated flange addresses one of the primary challenges of lyophilization by preventing sticking in freeze-drying equipment. Manufactured exclusively under Datwyler's FirstLine® standard—featuring advanced cleanroom technology, automated production cells, and camera inspection—OmniFlex® meets the most stringent European and US regulatory requirements. With a global manufacturing footprint and a non-fluorosurfactant fluoropolymer, OmniFlex® also supports supply chain resilience and a lower carbon footprint than comparable coated solutions.
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