Abstract
A study was designed to evaluate a new syringe system developed specifically for sensitive pharmaceutical and biopharmaceutical drug products. An in-depth review of the extractables portion of this program is presented and includes data generated by liquid chromatography-mass spectroscopy, gas chromatography-mass spectroscopy, ion chromatography, and inductively coupled plasma of the Crystal Zenith® barrel before and after sterilization. One leachable was identified after e-beam irradiation processing. This leachable, identified as an organic acid species, was then evaluated from a safety assessment viewpoint. The details of this program and associated results are explained in this report.
- Cyclic olefin polymer (COP)
- Extractables
- Leachables
- Qualification threshold (QT)
- Safety concern threshold (SCT)
- Syringe barrel
Footnotes
- © PDA, Inc. 2009
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