PT  - JOURNAL ARTICLE
AU  - Nashed-Samuel, Yasser
AU  - Torraca, Gianni
AU  - Liu, Dengfeng
AU  - Fujimori, Kiyoshi
AU  - Zhang, Zhongqi
AU  - Wen, Zai-Qing
AU  - Lee, Hans
TI  - Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
DP  - 2010 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 242--248
VI  - 64
IP  - 3
4099  - http://journal.pda.org/content/64/3/242.short
4100  - http://journal.pda.org/content/64/3/242.full
SO  - PDA J Pharm Sci Technol2010 May 01; 64
AB  - 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.© PDA, Inc. 2010