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Container Closure Integrity Testing of Prefilled Syringes.
Journal article

Container Closure Integrity Testing of Prefilled Syringes.

  • Peláez SS Lonza AG, Drug Product Services, Basel, Switzerland.
  • Mahler HC Lonza AG, Drug Product Services, Basel, Switzerland.
  • Matter A Lonza AG, Drug Product Services, Basel, Switzerland.
  • Koulov A Lonza AG, Drug Product Services, Basel, Switzerland.
  • Singh SK Lonza AG, Drug Product Services, Basel, Switzerland.
  • Germershaus O Institute for Pharma Technology, School of Life Sciences, University of Applied Sciences Northwestern Switzerland, Muttenz, Switzerland.
  • Mathaes R Lonza AG, Drug Product Services, Basel, Switzerland. Electronic address: roman.mathaes@lonza.com.
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  • 2018-04-08
Published in:
  • Journal of pharmaceutical sciences. - 2018
USP <1207>
container closure integrity testing
mass spectrometry-based helium leak detection
prefilled syringe
primary packaging
Drug Packaging
Equipment Design
Glass
Helium
Humans
Injections
Mass Spectrometry
Materials Testing
Pharmaceutical Preparations
Polymers
Syringes
English Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems (CCSs) for injectable drug products when facilitated or self-administration is required. However, PFSs are more complex compared to CCSs consisting of vial, rubber stopper, and crimp cap. Container closure integrity (CCI) assurance and verification has been a specific challenge for PFSs as they feature several sealing areas. A comprehensive understanding of the CCS is necessary for an appropriate CCI assessment as well as for packaging development and qualification. A comprehensive CCI assessment of 6 different PFSs from 3 different manufacturers (including 1 polymeric PFS) was conducted using helium leak testing. PFS components were manipulated to systematically assess the contribution of the different sealing areas to CCI, namely rigid needle shield (RNS)/needle, RNS/tip cone, and the individual ribs of a syringe plunger. The polymeric PFS required an equilibrium measurement for accurate container closure integrity testing. The different sealing areas and a single plunger rib were shown to provide adequate CCI. Acceptable tip cap movement until the point of CCI failure was estimated. The assessment of acceptable tip cap movement demonstrated the importance of considering the RNS/tip cone seal design to ensure CCI of the PFS upon post assembly possesses and shipment.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://sonar.ch/global/documents/248716
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