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Research ArticleTechnology/Application

Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods

“Gary” Guiyang Li, Shawn Cao, Nancy Jiao and Zai-Qing Wen
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 362-372; DOI: https://doi.org/10.5731/pdajpst.2014.00986
“Gary” Guiyang Li
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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  • For correspondence: guiyangl@amgen.com
Shawn Cao
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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Nancy Jiao
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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Zai-Qing Wen
Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA
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Abstract

Glass vials have been used as primary containers for parenteral drugs including biopharmaceuticals. Different types of glass-related particles, although in low occurrence rate, may be adventitiously introduced in these parenterals. Proper classification and investigations of these glass-related particles may help to understand their formation, improve process control, reduce glass-related particles, and deliver safe parenteral drugs to patients. In this article, we introduced a classification scheme, and identification procedures and methods, for the glass-related particles. We propose to classify them as glass chip, glass lamella/flake, and silica gel. Eight characteristics for each glass particle type have been identified and described for the visual inspection method. The limitations of the visual method and the need to correlate visual results with forensic analysis are discussed. Using representative examples from each type of glass particle, this study summarized their forensic differentiations based on microscopic methods of optical microscopy, scanning electron microscopy, micro-flow imaging, and spectroscopic methods of dnergy-dispersive spectroscopy and Fourier transform infrared spectroscopy. The mechanisms of glass particle formation are listed as references for drug development scientists to investigate the root causes and improve process control on visible glass particles in parenteral vials.

LAY ABSTRACT: Glass vials have been used as primary containers for parenteral drugs including biopharmaceuticals. Different types of glass-related particles, although in low occurrence rate, may be adventitiously introduced in these parenterals. Proper classification and investigations of these glass-related particles may help to understand their formation, improve process control, reduce glass-related particles, and deliver safe parenteral drugs to patients. In this article, we introduced a classification scheme, and identification procedures and methods, for the glass-related particles. We propose to classify them as glass chip, glass lamella/flake, and silica gel. Using representative examples from each type of glass particle, this study summarized their forensic differentiations based on microscopic and spectroscopic methods. The mechanisms of glass particle formation are listed as references for drug development scientists to investigate the root causes and improve process control on visible glass particles in parenteral vials.

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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods
“Gary” Guiyang Li, Shawn Cao, Nancy Jiao, Zai-Qing Wen
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 362-372; DOI: 10.5731/pdajpst.2014.00986

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Classification of Glass Particles in Parenteral Product Vials by Visual, Microscopic, and Spectroscopic Methods
“Gary” Guiyang Li, Shawn Cao, Nancy Jiao, Zai-Qing Wen
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 362-372; DOI: 10.5731/pdajpst.2014.00986
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