Identification of an extraneous black particle in a glass syringe: extractables/leachables case study

PDA J Pharm Sci Technol. 2010 May-Jun;64(3):242-8.

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.

MeSH terms

  • Drug Contamination
  • Drug Packaging*
  • Food Contamination
  • Gas Chromatography-Mass Spectrometry
  • Pharmaceutical Solutions
  • Spectroscopy, Fourier Transform Infrared
  • Syringes*

Substances

  • Pharmaceutical Solutions