Webinar

When Size Matters: Evolution of Self-Delivery Solutions for Subcutaneous Administration

How the full NeoFlex™ plunger range — V9555, V9547, and V9621 — maps to the complete large-volume subcutaneous delivery landscape across 10mL auto-injectors and 5mL, 10mL, and 20mL on-body wearable injector platforms
Statistically derived break-loose force limits from actual Sorrel™ device measurements — and what they mean for NeoFlex™ V9547 and V9621 plunger qualification
Dose accuracy, glide force stability, and hold-up volume data across 8 complete test configurations in Stevanato Group EZ-fill® pharmaceutical cartridges with the LTS Sorrel™ wearable platform

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Format Webinar

Language English

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Resource Overview

About this Webinar

Large-volume subcutaneous self-administration of biologics is no longer an emerging concept — it is a development priority. The growing use of high-viscosity mAbs, biosimilars, and GLP-1 receptor agonists requiring doses of 5mL or more is driving demand for primary container sealing solutions and wearable delivery devices that are validated together as integrated systems, not as isolated components.

This on-demand session, presented at Pharmapack 2026 by Datwyler, Stevanato Group, and LTS Device Technologies, delivers the most comprehensive functional dataset yet for large-volume subcutaneous self-administration — covering the full NeoFlex™ plunger range across all major SC delivery formats and presenting pre-verified platform data across break-loose force, glide force, dose accuracy, and hold-up volume.

How the full NeoFlex™ plunger range — V9555, V9547, and V9621 — covers the complete large-volume subcutaneous delivery landscape across auto-injector and on-body wearable formats
What statistically derived break-loose force limits from 4,905 actual Sorrel™ device vacuum force measurements mean for NeoFlex™ V9547 and V9621 plunger qualification acceptance criteria
How one-month BLF and GF stability data across steam and gamma sterilization and both refrigerated and ambient storage confirms NeoFlex™ platform performance under real-world conditions
What dose accuracy within ±5%, patient-centric delivery times, and hold-up volumes below 0.139mL across 8 test configurations demonstrate about the Datwyler/Stevanato Group/LTS system's readiness for large-volume biologic self-administration
Why pre-verified drug-agnostic platforms compress pharmaceutical development timelines for large-volume SC programs — and why complete drug-specific assessment and customization is always required before regulatory submission

KEY TOPICS COVERED

Mapping the NeoFlex™ plunger range to the SC delivery landscape

The complete NeoFlex™ product range is mapped across large-volume SC delivery scenarios: V9555 for 10mL large-volume auto-injectors in ISO 11040-4:2024 prefilled syringes; V9547 for 5–10mL on-body pharmaceutical cartridges with 19.05mm internal diameter; and V9621 for 20mL on-body devices with 23.85mm internal diameter. Stevanato Group's EZ-fill® platform across 5mL, 10mL, and 20mL is detailed with full dimensional specifications.

Statistically derived break-loose force limits

LTS generated break-loose force limits from actual Sorrel™ device vacuum force measurements across 4,905 device assemblies — establishing statistically derived maximum allowable break-loose force limits of 17.728N for 5/10mL systems and 27.788N for 20mL systems. These quantitative, device-validated acceptance criteria give pharmaceutical teams a concrete basis for NeoFlex™ V9547 and V9621 plunger qualification.

BLF and GF stability across storage conditions and sterilization methods

Datwyler's one-month break-loose force and glide force stability testing across three pharmaceutical cartridge sizes at both 5–8°C and 20°C storage, and across both steam and gamma sterilization, confirms all maximum break-loose force values remain below device limits and glide forces remain stable throughout — regardless of sterilization method or storage condition.

Dose accuracy, delivery time, and hold-up volume

Eight complete test configurations across 4mL, 10mL, and 20mL volumes at 1cP and 60cP viscosities confirm dose accuracy within ±5% for all configurations, patient-centric delivery times, and hold-up volumes of 0.139mL (20mL pharmaceutical cartridge) and 0.132mL (10mL pharmaceutical cartridge) — both well within specification limits.

WHO THIS WEBINAR IS FOR

This session is designed for formulation scientists, packaging engineers, drug delivery device teams, and regulatory affairs professionals evaluating primary packaging components and integrated platform solutions for large-volume subcutaneous biologics in wearable injector and on-body delivery platforms.

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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.

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Helpful Information

Frequently Asked Questions

What does this webinar cover?

This on-demand session presents the most comprehensive functional dataset yet for large-volume subcutaneous self-administration, covering the full NeoFlex™ plunger range across SC delivery formats and delivering pre-verified platform data on break-loose force limits, glide force stability, dose accuracy, delivery time, and hold-up volume in Stevanato Group EZ-fill® pharmaceutical cartridges with the LTS Sorrel™ wearable platform.

When and where was this session presented?

This session was presented at Pharmapack 2026 by Datwyler, Stevanato Group, and LTS Device Technologies. The full recording is available on-demand.

Is this session available on-demand?

Yes. The full presentation is available to watch on-demand after a short registration, typically completed in under 30 seconds.

Who presented this session?

Paolo Ferrigno, Product Manager for Prefilled Syringes and Cartridges at Datwyler Healthcare, presented alongside Stevanato Group's Product Manager for Cartridge Platform and LTS Device Technologies' Executive VP of New Business Development.

What are the NeoFlex™ V9547 and V9621 plungers?

The V9547 is Datwyler's NeoFlex™ plunger for 5–10mL on-body pharmaceutical cartridges with a 19.05mm internal diameter. The V9621 is the NeoFlex™ plunger for 20mL on-body pharmaceutical cartridges with a 23.85mm internal diameter, aligned to ISO 13926-1 draft standards. Both are built on the FM457 BIMS substrate with a covalently bonded fluoropolymer coating, eliminating the need for siliconization and minimizing extractables and leachables risk for sensitive biologic formulations.

What is a pre-verified platform and why does it matter?

A pre-verified platform combines a primary container, sealing component, and wearable delivery device that have been validated together as an integrated system across key functional parameters — including break-loose force limits, glide force stability, dose accuracy, and hold-up volume. Pre-verified drug-agnostic platforms compress pharmaceutical development timelines for large-volume SC programs by providing a validated starting point. However, the final configuration always requires complete drug-specific assessment and customization before regulatory submission.

What is the significance of the break-loose force data in this study?

The break-loose force limits presented — 17.728N for 5/10mL systems and 27.788N for 20mL systems — were derived statistically from 4,905 actual Sorrel™ device vacuum force measurements using a six-sigma analysis. This gives pharmaceutical teams quantitative, device-validated acceptance criteria for NeoFlex™ V9547 and V9621 plunger qualification, rather than relying on estimated or theoretical limits.