RT Journal Article
SR Electronic
T1 Identification of an Extraneous Black Particle in a Glass Syringe: Extractables/Leachables Case Study
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 242
OP 248
VO 64
IS 3
A1 Nashed-Samuel, Yasser
A1 Torraca, Gianni
A1 Liu, Dengfeng
A1 Fujimori, Kiyoshi
A1 Zhang, Zhongqi
A1 Wen, Zai-Qing
A1 Lee, Hans
YR 2010
UL http://journal.pda.org/content/64/3/242.abstract
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