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Research ArticleRESEARCH

Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study

Yasser Nashed-Samuel, Gianni Torraca, Dengfeng Liu, Kiyoshi Fujimori, Zhongqi Zhang, Zai-Qing Wen and Hans Lee
PDA Journal of Pharmaceutical Science and Technology May 2010, 64 (3) 242-248;
Yasser Nashed-Samuel
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  • For correspondence: snashed@amgen.com
Gianni Torraca
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Dengfeng Liu
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Kiyoshi Fujimori
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Zhongqi Zhang
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Zai-Qing Wen
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Hans Lee
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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.

  • Syringe
  • Nylon
  • Leachables
  • Extractables
  • © PDA, Inc. 2010
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PDA Journal of Pharmaceutical Science and Technology: 64 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 3
May/June 2010
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Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
Yasser Nashed-Samuel, Gianni Torraca, Dengfeng Liu, Kiyoshi Fujimori, Zhongqi Zhang, Zai-Qing Wen, Hans Lee
PDA Journal of Pharmaceutical Science and Technology May 2010, 64 (3) 242-248;

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Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
Yasser Nashed-Samuel, Gianni Torraca, Dengfeng Liu, Kiyoshi Fujimori, Zhongqi Zhang, Zai-Qing Wen, Hans Lee
PDA Journal of Pharmaceutical Science and Technology May 2010, 64 (3) 242-248;
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  • Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
  • Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
  • The Use of TOC Reconciliation as a Means of Establishing the Degree to Which Chromatographic Screening of Plastic Material Extracts for Organic Extractables Is Complete
  • Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products
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