Container Closure Integrity Testing of Prefilled Syringes,

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Authors
Pelaez, Sarah
Mahler, Hanns-Christian
Koulov, Atanas
Singh, Satish K.
Mathaes, Roman
Author (Corporation)
Publication date
08/2018
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01A - Journal article
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Parent work
Journal of Pharmaceutical Sciences
Special issue
DOI of the original publication
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Series number
Volume
107
Issue / Number
8
Pages / Duration
2091-2097
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Publisher / Publishing institution
Elsevier
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Abstract
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.
Keywords
container closure integrity testing, prefilled syringe, primary syringe, mass spectrometry-based helium leak detection, USP <1207>
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ISSN
0022-3549
1520-6017
Language
English
Created during FHNW affiliation
Yes
Publication status
Published
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Peer review of the complete publication
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Citation
PELAEZ, Sarah, Hanns-Christian MAHLER, Atanas KOULOV, Satish K. SINGH, Oliver GERMERSHAUS und Roman MATHAES, 2018. Container Closure Integrity Testing of Prefilled Syringes,. Journal of Pharmaceutical Sciences. August 2018. Bd. 107, Nr. 8, S. 2091–2097. DOI 10.1016/j.xphs.2018.03.025. Verfügbar unter: http://hdl.handle.net/11654/27328