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Access webinars, technical articles, white papers, and industry insights designed to support informed decision-making.
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Explore technical resources and industry perspectives
Access curated content designed to support informed decisions across drug delivery, packaging, and patient-centered innovation.
WHITE PAPER
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.
TECHNICAL ARTICLE
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.
TECHNICAL ARTICLE
The evolving landscape of subcutaneous drug administration
In the new subcutaneous drug delivery landscape, the growing trend towards patient-friendly, at-home administration is driving demand for larger volume packaging formats. How is the industry and its supply chain responding?
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WEBINAR
Annex 1 in Practice: How Component Design and Manufacturing Support Your Contamination Control Strategy
This webinar examines how primary packaging and drug delivery component selection, manufacturing, and supplier documentation directly support a sterile manufacturer’s contamination control strategy (CCS) under EU GMP Annex 1. Datwyler subject matter experts will walk through practical examples of component-level controls—including elastomer formulation choices, clean room–classified production, particulate and extractables testing, and qualification documentation—that quality and regulatory teams can incorporate into their own CCS and audit readiness.
CONFERENCE
Innopack Pharma Confex - Hyderabad
Datwyler returns to Innopack Pharma Confex in Hyderabad, engaging with India's growing community of pharmaceutical manufacturers and packaging professionals. Attendees can connect with our team to explore high-performance closures, stoppers, and elastomer components engineered for injectable and biologic drug applications across India's expanding domestic and export markets.
CONFERENCE
Suzhou Dialogue by CNPPA
Datwyler participates in this high-level industry dialogue hosted by the China National Pharmaceutical Packaging Association, with David Qiu taking the stage to discuss the technical challenges of elastomer components for high-value injectable drug products.
