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Partnering for System-Level Confidence

 

As biologics, sensitive vaccines, and combination products evolve, pharmaceutical companies are seeking earlier insight into assembled-system performance to support development decisions and address the expectations of USP <382>.​

Aptar Pharma partners with ecosystem players to deliver system-level data packages, giving drug developers the insight they need to trust how the complete system performs together.​

That confidence is built on two foundations:​

- Ecosystem partnerships: Collaboration with leading prefilled syringe partners across the value chain, combining component expertise and integrated testing into a single, reliable dataset.​

- System-level data packages: Integrated performance generated on the assembled system, not component by component, so you see how the whole system behaves early in development.​

The result: Confidence for drug development - actionable insight into functional performance and container closure integrity, so you can build your program on a system you can rely on.

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Why it matters for drug developers

Earlier Container Closure Decisions

System-level supports development choices well before the final drug product is defined, helping you move forward with confidence.​

USP <382>-Aligned Testing​

Insights that help inform internal testing strategies for the assembled system, aligned with evolving container closure integrity expectations.​

Confidence Before Scale-Up​

A more complete picture of assembled-system performance to help manage risks ahead of late-stage development and scale-up.​

System-Level Evidence​

The system-level data package combines expertise from Aptar Pharma and ecosystem partners to characterize the performance of complete syringe systems through a range of functional and integrity assessments.

 

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Pull-off force testing of an assembled syringe closure system using a mechanical force measurement instrument.

Pull-off Force (PoF)​

Closure Pull-Off Force (PoF) evaluates the force required to remove the Rigid Needle Shield (RNS) from a prefilled syringe. Data generated across representative system configurations enables comparison of closure performance within assembled syringe systems.​

These data can support selection of primary packaging combinations that achieve both secure closure retention and reliable shield removal throughout the product lifecycle.

Test method: Force is applied to the RNS at a controlled speed until removal, and the maximum force required is recorded. The method is performed according to an internally validated procedure aligned with USP <382>, Section 7 (Tip Cap and Needle Shield Functional Suitability Tests), Procedure A.​​

Mechanical testing equipment used to evaluate the functional performance of an assembled syringe system.

Break-Loose & Extrusion Force (BLEF)​

Break-Loose and Extrusion Force (BLEF) measures the forces required to initiate and maintain plunger movement during injection. Data generated across representative system configurations allows comparison of delivery performance across different component combinations and formulation characteristics.​

These data provide objective evidence of delivery performance across representative system configurations, supporting informed decision-making during system development. 

Test method: Controlled plunger movement is applied while continuously measuring the forces required to initiate and maintain delivery.​

Laboratory specialist using microscopy to inspect elastomeric components in a controlled environment

Container Closure Integrity Testing(CCIT)​

Container Closure Integrity (CCI) evaluates the ability of the assembled syringe system to maintain a barrier against external contamination throughout its lifecycle while remaining capable of delivering the drug safely and effectively. Data generated across representative system configurations enables assessment of integrity at critical component interfaces.​

These data provide evidence of system integrity and can support risk assessment activities related to storage, transport, and long-term product protection.

Test method: Helium tracer-gas testing is used to evaluate the integrity of the assembled system and identify potential leak pathways. Testing follows deterministic methods aligned with USP <382> and USP <1207>.​​​

Laboratory specialist operating analytical equipment and reviewing test data on a monitor.

Seal Integrity​

Seal Integrity evaluates the ability of the plunger closure system to maintain sealing performance under conditions representative of drug administration. Data generated across representative system configurations enables assessment of the interaction between plunger and syringe components.​

These results can support evaluation of sealing robustness under administration-related stresses and help inform component selection during system development.

Test method: A tracer solution and controlled pressure challenge are used to evaluate the ability of the plunger seal to maintain sealing performance during use. The method is executed using an internally validated procedure aligned with USP <382>, Section 6.2 (Plunger Seal Integrity), Procedure A.​​

Build your program on a system you can trust.​

Talk to our team about the system-level evidence behind your injectable configuration.​