Precision Components and Trusted Expertise for Injectable Drug Delivery
Supporting pharmaceutical partners from early development through commercialization with high-performance elastomer components and technical collaboration.
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Explore technical resources and industry perspectives
Double Sterilization in Pharmaceuticals: The Impact of Annex 1 on Component Strategy
Since the 2022 revision of EU GMP Annex 1 came into effect in August 2023, sterile manufacturing strategy has become one of the most consequential decisions in injectable drug development. What was once a binary choice between aseptic processing and terminal sterilization is shifting toward a hybrid "double sterilization" model — purchasing pre-sterilized, ready-to-use elastomeric components and then applying terminal sterilization again after filling and final assembly.
Lyophilization is growing in pharma, but technical challenges persist
In this technical article, Datwyler's Camille Ermine explores how lyophilization is reshaping pharmaceutical packaging decisions for biologics, mRNA therapeutics, ADCs, and orphan drugs — covering stopper geometry, moisture control, container closure integrity, and extractables and leachables risk, and how the right component choices help manufacturers navigate the fill-finish challenges that come with freeze drying.
The evolving landscape of subcutaneous drug administration
Connect with Datwyler Healthcare at industry-leading events
American Drug Delivery & Formulation Summit
Datwyler presents at the American Drug Delivery & Formulation Summit in Boston, September 14–15, where Alison Phillips, PhD, takes the stage on the critical role of elastomer component design in bridging formulation science and drug delivery system performance.
CPHI Milan
PDA Universe of Pre-Filled Syringes & Injection Devices
Datwyler attends PDA's premier prefilled syringe event, connecting with device engineers, formulation teams, and combination product specialists focused on the future of injectable drug delivery. Our experts discuss plunger design, syringe compatibility, coating technologies, and container closure integrity — bringing deep technical knowledge to one of the industry's most specialized forums.
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