Identification of an extraneous black particle in a glass syringe: extractables/leachables case study.
PDA J Pharm Sci Technol
; 64(3): 242-8, 2010.
Article
en En
| MEDLINE
| ID: mdl-21502024
ABSTRACT
An unexpected, black particle (â¼300 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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Jeringas
/
Embalaje de Medicamentos
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
PDA J Pharm Sci Technol
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos