Analysis of biopharmaceutical market-appropriate plastic syringe barrel for extractables.
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.
DeGrazio
Frances
F
West Pharmaceutical Services, 101 Gordon Drive, Lionville, PA 19341, USA. fran.degrazio@westpharma.com
Runkle
Joseph
J
Smythe
Jeff
J
Miller
Amy
A
D001688:Biological Products / Q000032:analysis / Q000592:standards; D002623:Chemistry Techniques, Analytical / Q000379:methods; D003516:Cycloparaffins / Q000032:analysis* / Q000737:chemistry; D004340:Drug Contamination / Q000517:prevention & control; D004349:Drug Packaging / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011108:Polymers / Q000032:analysis / Q000737:chemistry; D013242:Sterilization / Q000379:methods; D013594:Syringes / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000379:methods*
D001688:Biological Products; D003516:Cycloparaffins; D004364:Pharmaceutical Preparations; D011108:Polymers