Analysis of biopharmaceutical market-appropriate plastic syringe barrel for extractables

PDA J Pharm Sci Technol. 2009 Jul-Aug;63(4):360-7.

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.

MeSH terms

  • Biological Products / analysis
  • Biological Products / standards
  • Chemistry Techniques, Analytical / methods
  • Cycloparaffins / analysis*
  • Cycloparaffins / chemistry
  • Drug Contamination / prevention & control
  • Drug Packaging / standards
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / standards
  • Polymers / analysis
  • Polymers / chemistry
  • Sterilization / methods
  • Syringes / standards*
  • Technology, Pharmaceutical / methods*

Substances

  • Biological Products
  • Cycloparaffins
  • Pharmaceutical Preparations
  • Polymers