The collaboration combines glass syringe platforms and elastomeric components to generate early system-level performance data, supporting pharmaceutical companies in selecting packaging configurations for sensitive biologics and injectable therapies.
Aptar Pharma and Stevanato Group have announced a collaboration to help pharmaceutical and biotechnology companies accelerate the evaluation and selection of pre-filled syringe (PFS) systems for complex injectable therapies.
The initiative brings together Stevanato Group's expertise in glass syringe platforms and primary drug containment with Aptar Pharma's capabilities in elastomeric components and injectable drug delivery systems. The joint programme aims to provide pharmaceutical developers with system-level performance data earlier in the product development process, helping them make more informed packaging decisions.
As biologics, high-concentration formulations and combination products become increasingly complex, selecting compatible container closure components has become a critical part of pharmaceutical development. Evaluating individual components in isolation may not fully capture their interactions when assembled into a complete delivery system.
Integrated Evaluation of Syringe Components
The collaboration combines Stevanato Group's EZ-fill® Nexa® and Alba® glass syringe platforms with Aptar Pharma's PremiumCoat® and uncoated plungers, along with its rigid needle shield solutions for standard syringe and autoinjector configurations.
The joint evaluations currently cover 1 mL long and 2.25 mL syringe formats, examining how different component combinations influence overall system performance across selected configurations and viscosity profiles.
Key testing parameters include:
- Rigid needle shield pull-off force: Evaluating the force required to remove the needle shield before administration.
- Plunger break-loose and extrusion forces: Assessing the forces required to initiate and maintain plunger movement during drug delivery.
- Container closure integrity (CCI): Evaluating the ability of the assembled packaging system to maintain an effective barrier against external contamination.
- Plunger seal integrity: Assessing the performance of the plunger seal within the syringe barrel.
The testing approach is designed to support pharmaceutical customers in meeting the relevant requirements of USP General Chapter <382>, which addresses elastomeric component functionality in injectable pharmaceutical packaging systems.
Supporting Early Development Decisions
By generating performance data at the assembled-system level, the collaboration aims to help pharmaceutical development teams identify potential technical challenges earlier, narrow down suitable packaging configurations and reduce uncertainty during feasibility assessments.
The programme also examines how variables such as needle geometry can influence plunger break-loose and extrusion forces, providing additional insights into the interaction between syringe components and drug formulations.
In addition to testing, the companies will make data packages and regulatory support services available to assist pharmaceutical manufacturers throughout the product development lifecycle, from initial feasibility assessments to scale-up and commercialisation.
Strengthening Pharmaceutical Packaging Collaboration
The collaboration builds on Aptar Pharma's integrated system-level framework, launched in July 2026, and reflects the growing importance of partnerships across the injectable drug delivery value chain.
By combining expertise in primary containment, elastomeric components and assembled-system performance, Aptar Pharma and Stevanato Group aim to provide pharmaceutical companies with better visibility into component interactions and packaging system suitability.
The initiative is particularly relevant for sensitive biologics, concentrated formulations and other injectable therapies where container closure integrity, functional performance and compatibility are essential considerations.
The companies emphasise that pharmaceutical manufacturers remain responsible for demonstrating the suitability and regulatory compliance of their final drug product packaging and delivery systems.
Through this collaboration, both companies aim to support more informed pre-filled syringe selection and help pharmaceutical developers navigate the technical challenges associated with increasingly complex injectable therapies.