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Container Closure Integrity Testing of Prefilled Syringes.

Sarah S Peláez1, Hanns-Christian Mahler1, Anja Matter1

  • 1Lonza AG, Drug Product Services, Basel, Switzerland.

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|April 8, 2018
PubMed
Summary

Prefilled syringes (PFSs) offer advantages for self-administration but present container closure integrity (CCI) challenges. Comprehensive testing confirmed that key sealing areas in PFS designs adequately ensure CCI for drug products.

Keywords:
USP <1207>container closure integrity testingmass spectrometry-based helium leak detectionprefilled syringeprimary packaging

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Area of Science:

  • Pharmaceutical Packaging
  • Drug Delivery Systems
  • Container Closure Integrity

Background:

  • Prefilled syringes (PFSs) are increasingly used for injectable drugs, replacing traditional vials.
  • PFSs present unique challenges for container closure integrity (CCI) due to multiple sealing areas.
  • A thorough understanding of PFS components is crucial for packaging development and CCI assessment.

Purpose of the Study:

  • To conduct a comprehensive CCI assessment of various PFSs from different manufacturers.
  • To systematically evaluate the contribution of individual sealing areas to overall PFS CCI.
  • To determine acceptable limits for tip cap movement to ensure PFS CCI.

Main Methods:

  • Helium leak testing was employed to assess CCI in six different PFSs, including one polymeric version.
  • PFS components were manipulated to isolate and test the integrity of specific sealing areas.
  • Equilibrium measurement was utilized for accurate CCI testing of the polymeric PFS.

Main Results:

  • Multiple sealing areas, including the rigid needle shield (RNS)/needle, RNS/tip cone, and plunger ribs, were found to provide adequate CCI.
  • A single plunger rib was sufficient to maintain CCI.
  • Acceptable tip cap movement thresholds were estimated, highlighting the importance of the RNS/tip cone seal.

Conclusions:

  • The study demonstrates that carefully designed sealing areas in PFSs can ensure robust container closure integrity.
  • Understanding the contribution of each sealing component is vital for reliable CCI verification.
  • The RNS/tip cone seal design is critical for maintaining PFS CCI throughout post-assembly and shipping.