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Overcoming device component-related challenges and risks in prefilled syringe development.

Bettine Boltres1, Fran deGrazio2, Susan Neadle3

  • 1West Pharmaceutical Services bettine.boltres@westpharma.com.

PDA Journal of Pharmaceutical Science and Technology
|January 18, 2026
PubMed
Summary
This summary is machine-generated.

Developing prefilled syringes (PFS) involves complex regulatory and technical challenges. This paper identifies four systemic issues and proposes strategies for a more efficient and predictable development process for safe and effective PFS.

Keywords:
combination productdevice constituent partdevice developmentprefilled syringesprimary packaging components

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Area of Science:

  • Pharmaceutical development
  • Combination product regulation
  • Medical device engineering

Background:

  • Prefilled syringes (PFS) are combination products with complex development pathways.
  • Challenges in PFS development can lead to delays, increased costs, and market access barriers.
  • Existing issues often stem from systemic, rather than isolated, technical failures.

Purpose of the Study:

  • To identify and analyze systemic challenges in prefilled syringe development.
  • To illustrate how these challenges manifest as concrete risks during the development process.
  • To propose system-level strategies for mitigating risks and improving PFS development.

Main Methods:

  • Analysis of recurring issues in PFS development.
  • Examination of specific examples like break-loose forces, silicone oil, particles, endotoxins, and biocompatibility.
  • Review of regulatory interactions, including those under the Medical Device Regulation (MDR).

Main Results:

  • Four key systemic challenges identified: diverging regulatory requirements, divided competencies, fragmented supply chains, and non-standardized characterization.
  • These challenges create risks in transitions (e.g., vial to syringe) and regulatory compliance.
  • Specific examples highlight the impact of these challenges on product development.

Conclusions:

  • Addressing systemic challenges requires integrated risk management, clearer system ownership, and early collaboration.
  • Harmonized standards and regulatory expectations are crucial for efficient development.
  • Implementing these strategies supports a predictable, science-based pathway for safe and effective PFS.