title: Glass delamination: a comparison of the inner surface performance of vials and pre-filled syringes.
abstract: The occurrence of glass delamination is a serious concern for parenteral drug products. Over the past several years, there has been a series of product recalls involving glass delamination in parenteral drugs stored in vials which has led to heightened industry and regulatory scrutiny. In this study, a two-pronged approach was employed to assess the inner surface durability of vials and pre-filled syringes. Non-siliconized syringes were used in order to directly compare glass to glass performance between vials and syringes. The vial and syringe performance was screened with pharmaceutically relevant formulation conditions. The influence of pH, buffer type, ionic strength, and glass type and source was evaluated. In addition, an aggressive but discriminating formulation condition (glutaric acid, pH 11) was used to ascertain the impact of syringe processing. Advanced analytical tools including inductively coupled plasma/mass spectrometry, scanning electron microscopy, atomic force microscopy, and dynamic secondary ion mass spectroscopy showed significant differences in glass performance between vials and syringes. Pre-filled syringes outperform vials for most tests and conditions. The manufacturing conditions for vials lead to glass defects, not found in pre-filled syringes, which result in a less chemically resistant surface. The screening methodology presented in this work can be applied to assess suitability of primary containers for specific drug applications.
authors.affiliation: BD Medical-Pharmaceutical Systems, One Becton Drive, Franklin Lakes, New Jersey, 07417, USA.
authors.forename: Jianxiu
authors.initials: J
authors.lastname: Zhao
authors.forename: Virginie
authors.initials: V
authors.lastname: Lavalley
authors.forename: Paolo
authors.initials: P
authors.lastname: Mangiagalli
authors.forename: Justin M
authors.initials: JM
authors.lastname: Wright
authors.forename: Theresa E
authors.initials: TE
authors.lastname: Bankston
mesh_terms: D002021:Buffers; D004349:Drug Packaging; D004867:Equipment Design; D005898:Glass / Q000737:chemistry*; D006813:Humidity; D006863:Hydrogen-Ion Concentration; D006868:Hydrolysis; D013058:Mass Spectrometry; D018625:Microscopy, Atomic Force; D008855:Microscopy, Electron, Scanning; D009994:Osmolar Concentration; D012995:Solubility; D013054:Spectrophotometry, Atomic; D013499:Surface Properties; D013594:Syringes; D013678:Technology, Pharmaceutical / Q000379:methods; D013997:Time Factors
chemical_list: D002021:Buffers