Webinar
Flawless Functionality: Optimizing Injectable Drug Stability and Performance
Part of Datwyler's P.E.R.F.E.C.T.-ing the Pharmaceutical Packaging Selection Process webinar series, this on-demand session maps the full functional performance landscape of elastomeric components across vial, prefilled syringe, and cartridge systems — covering container closure integrity (CCI), fragmentation and coring, break-loose and gliding force, plunger seal integrity, plunger movement during transport, and needle shield and tip cap removal forces under the updated USP <382> framework.
Status
Published
Format
Webinar
Language
English
Access
Registration Required
Resource Overview
About this Webinar
Container closure systems for injectable drugs must satisfy three interdependent performance imperatives simultaneously: safety, efficacy, and stability — and achieving all three requires elastomeric components that perform flawlessly across a broad set of functional criteria spanning the entire delivery system lifecycle. This on-demand webinar, part of Datwyler's P.E.R.F.E.C.T.-ing the Pharmaceutical Packaging Selection Process series, provides pharmaceutical packaging engineers, formulation scientists, and device development teams with a structured overview of the functionality landscape for elastomeric closures across vial, prefilled syringe, and cartridge systems. The session addresses the regulatory shift from component-level suitability testing under the historic USP <381> to system-level fitness-for-intended-use assessment under USP <382>, including its expanded scope beyond vial systems to cover syringes, cartridges, and pen injector formats. Functional performance categories covered in detail include: CCI assessment at room temperature via helium-leak methods and at cold temperatures via CO₂ ingress, with flange-neck area and rib-barrel interference identified as the primary sealing contributors; penetration force and re-sealing capacity for vial systems; fragmentation and coring risk under multi-needle piercing; spike retention and sealability; break-loose and gliding force profiles and the clinical consequences of high or inconsistent force profiles; plunger seal integrity assessment; plunger movement in low-pressure environments during air transport to verify sterility maintenance; and needle shield and tip cap axial pull-off and torque removal forces.
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Expert Spotlight
Meet the Expert
Paolo Ferrigno
Product Manager, Prefilled Syringes and Cartridges
·
Datwyler
In the industry of primary parenteral packaging since 2017, Paolo Ferrigno is the product manager for prefilled syringes and cartridge components at Datwyler Healthcare. At Datwyler, Ferrigno has covered different commercial and technical roles before landing back in product management in 2022. Educated in electronics and later in marketing, Ferrigno has had a wide range of experiences spanning R&D for audio/electronics in the automotive and consumer markets and product management for B2B distribution of industrial and electronics components.
