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Service Offering: Single Source Solution Competence

From compound selection and custom product design to container closure integrity (CCI) testing and supply chain continuity, Datwyler Engineering Certainty into every stage of your drug packaging program.

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Datwyler's Single Source Solution Competence gives pharmaceutical manufacturers access to a comprehensive suite of technical services covering the full parenteral packaging development lifecycle. Lab testing capabilities span pharmacopoeia and normative testing per E.P.3.2.9 / USP<381> and USP<382>, functionality testing including residual seal force and gliding profile for prefilled syringes and cartridges, container closure integrity (CCI) testing via laser-based headspace analysis and helium-leak methods, and extractables and leachables services. The co-engineering program embeds Datwyler's compound and tooling expertise directly into custom product design, with Finite Element Analysis (FEA) enabling early-stage identification of deformation, contact pressure, and material stress risks before physical prototypes exist. Business continuity planning — backed by globally aligned equipment standards, multi-site production, and three-stage disaster recovery protocols at every manufacturing facility — ensures that supply chain resilience is built into every customer relationship.

Comprehensive lab testing aligned to global regulatory standards. Datwyler's testing portfolio covers pharmacopoeia and normative testing per E.P.3.2.9 / USP<381> and <382>, ICP elemental impurities per ICH Q3D, container closure integrity (CCI) using both laser-based headspace analysis and helium-leak methods, and extractables and leachables services — providing the full analytical documentation needed to support regulatory submissions.
Co-engineering and FEA accelerate development and reduce cost. Through a structured three-phase co-engineering process — product design, product analysis, and customized engineering activities — Datwyler integrates compound selection, 3D dimensional analysis, and Finite Element Analysis (FEA) early in the development cycle, enabling customers to identify functional and production risks before prototype tooling is committed and reducing both material costs and total investment outlay.
Multi-site business continuity planning protects supply chain integrity. Every Datwyler manufacturing facility operates under a three-stage disaster recovery framework, with globally harmonized equipment, process parameters, and in-house tooling standards across all sites — including redundant manufacturing locations for fluoropolymer spray coated components — to ensure uninterrupted product availability regardless of regional disruptions.

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Service Offering: Single Source Solution Competence

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