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StarterPack™: A Comprehensive Packaging Solution

StarterPack™ provides pharmaceutical developers with a single-source, ready-to-use container closure system — pre-validated for container closure integrity (CCI) and scalable from clinical trial quantities to commercial launch.

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The Datwyler StarterPack™ is designed to eliminate the complexity of sourcing compatible primary and secondary packaging components across the drug development continuum. The solution bundles ready-to-use (RTU) OmniFlex® stoppers in the FM457 bromobutyl formulation — featuring Datwyler's proprietary fluoropolymer spray coating and FirstLine® manufacturing standards — with PrimeCaps™ aluminum seals and SCHOTT Pharma adaptiQ® borosilicate glass vials produced to ISO 9001 and ISO 15378 standards. The entire system is pre-sterilized, CCI-tested using standard methods required by regulatory authorities, and available in small quantities to support diagnostic research, Phase 0 through Phase III clinical trials, and eventual commercial scale-up. Compatible 13 mm and 20 mm configurations in igloo and non-blowback designs give development teams the flexibility to align packaging selection with both current testing needs and future fill-finish requirements.

A single-source RTU packaging system pre-validated for CCI across clinical trial phases. The StarterPack™ combines OmniFlex® RTU stoppers, PrimeCaps™, and SCHOTT Pharma glass vials into a pre-tested container closure system verified for sealing compatibility, container closure integrity (CCI), and freedom from subvisible particle contamination — removing the need for customers to independently qualify each component.
FM457 bromobutyl compound and fluoropolymer coating deliver superior chemical compatibility for sensitive drug products. Datwyler's proprietary FM457 formulation provides ultra-low extractables, high resistance to gamma irradiation, and superior functional characteristics; paired with a proprietary fluoropolymer spray coating applied under FirstLine® quality standards, the combination ensures a robust barrier against drug-stopper interaction and eliminates the need for siliconization.
Scalable quantities support the full drug development lifecycle from pre-clinical to commercial launch. StarterPack™ components are available in controlled small quantities — 500 to 1,000 pieces per box depending on configuration — enabling development teams to use the same high-quality commercial packaging components in early-stage testing and then scale volumes directly to production-ready quantities without qualification re-work.

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StarterPack™: A Comprehensive Packaging Solution

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