title: Identification of an extraneous black particle in a glass syringe: extractables/leachables case study.
abstract: An unexpected, black particle (∼300 microns) was visually observed adhering to the interior shoulder of a prefilled glass syringe containing a biological drug product. The goal of this study was to determine the source, identity, and leachables of the black particle. The particle originated from a polymeric pin used during the syringe manufacturing process. Fourier transform infrared (FTIR) spectra comparison of the black particle and polymeric pin correlated to a database match of Nylon-MXD6 with glass fibers. Liquid chromatography/mass spectroscopy analyses identified Nylon-MXD6 and Nylon-6 photo-oxidized-related compounds in both the pin extract and syringe solution. The black particle originated from the pin and contained glass fibers, Nylon-MXD6, and Nylon-6. All nylon-related compounds were observed at <260 ng/mL (ppb) in the syringe solution. Syringes without black particles contained no detectable levels of nylon-related compounds, suggesting that routine contact between a pin and syringe barrel may not lead to syringe contamination or leachables originating from the pin. Abnormal heat exposure and/or extensive pin usage may have led to pin wear and tear.
authors.affiliation: Department of Formulation and Analytical Resources, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
authors.forename: Yasser
authors.initials: Y
authors.lastname: Nashed-Samuel
authors.forename: Gianni
authors.initials: G
authors.lastname: Torraca
authors.forename: Dengfeng
authors.initials: D
authors.lastname: Liu
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Fujimori
authors.forename: Zhongqi
authors.initials: Z
authors.lastname: Zhang
authors.forename: Zai-Qing
authors.initials: ZQ
authors.lastname: Wen
authors.forename: Hans
authors.initials: H
authors.lastname: Lee
mesh_terms: D004340:Drug Contamination; D004349:Drug Packaging; D005506:Food Contamination; D008401:Gas Chromatography-Mass Spectrometry; D019999:Pharmaceutical Solutions; D017550:Spectroscopy, Fourier Transform Infrared; D013594:Syringes
chemical_list: D019999:Pharmaceutical Solutions