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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
Pharmaceutical Elastomers and Aluminum Seals in Parenteral Packaging Systems
Datwyler hosts this industry-leading two-day PDA training course at its FirstLine® manufacturing facility in Middletown, Delaware, offering pharmaceutical professionals an unmatched, hands-on learning experience in parenteral packaging. Led by Datwyler and PDA industry experts, the course covers elastomer fundamentals, component selection strategies, manufacturing technologies, sterilization techniques, defect analysis, and regulatory requirements governing elastomeric closures and aluminum seals. Attendees also participate in a guided plant tour of Datwyler's state-of-the-art FirstLine® facility — providing rare, real-world insight into how high-quality parenteral packaging components are made.
PODD Conference
PDA's Asia-Pacific Aseptic Processing of Biopharmaceuticals Conference
Datwyler attends PDA's Asia-Pacific biopharmaceuticals conference, joining industry leaders focused on aseptic manufacturing quality, contamination control, and container closure integrity. Our team shares expertise in ready-to-use component formats, sterilization validation, and elastomer performance — supporting biopharma manufacturers across the region in achieving the highest standards of aseptic processing.
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