Timmons Christopher L, Liu Chi Yuen, Merkle Stefan
Corning Incorporated, Corning, NY and
Janssen AG, Schaffhausen, Switzerland.
PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):379-392. doi: 10.5731/pdajpst.2017.007724. Epub 2017 May 15.
Contamination with foreign particulate matter continues to be a leading cause of parenteral drug recalls, despite extensive control and inspection during manufacturing. Glass is a significant source of particulate matter contamination; however, the mechanism, source, and quantification have not been extensively analyzed. Quantification of particulate matter generation with lab simulations suggests that glass-to-glass contact on the filling line produces large quantities of glass particles of various sizes. A new strengthened glass vial with a low coefficient of friction surface is proposed to address this root cause of glass particle generation. Lab simulations and two line trials using this new vial demonstrated a substantial reduction of glass particulate generation, of resulting product contamination, as well as of the frequency of required filling line interventions. These results suggest that substantial reductions in particulate matter contamination of all types, glass and non-glass, can be achieved through the use of a new glass vial designed to effectively eliminate a root cause of glass particle generation. Contamination with foreign particulate contamination continues to be a leading cause of injectable drug recalls, despite extensive control and inspection during manufacturing. Glass particles are one of the most common types of particulate identified; however, the generation mechanism has not been extensively studied. Lab simulations suggest that routine glass-to-glass contact of vials during the filling process results in large quantities of glass particulate. A new, strengthened glass vial with a low coefficient of friction surface is proposed to address this mechanism. Lab simulations and multiple filling line trials demonstrated a substantial reduction of glass particulate matter generation and product contamination with use of the new vial. These results suggest that this new vial reduces contamination risk by eliminating a root cause of glass particulate generation.
尽管在生产过程中进行了广泛的控制和检查，但外来颗粒物污染仍然是注射用药品召回的主要原因。玻璃是颗粒物污染的一个重要来源；然而，其产生机制、来源和量化尚未得到广泛分析。实验室模拟对颗粒物产生的量化结果表明，灌装线上玻璃瓶之间的接触会产生大量各种尺寸的玻璃颗粒。为解决玻璃颗粒产生的这一根源问题，提出了一种具有低摩擦系数表面的新型强化玻璃瓶。使用这种新瓶进行的实验室模拟和两次生产线试验表明，玻璃颗粒的产生、由此导致的产品污染以及灌装线所需干预的频率都大幅降低。这些结果表明，通过使用一种旨在有效消除玻璃颗粒产生根源的新型玻璃瓶，可以大幅减少所有类型（玻璃和非玻璃）的颗粒物污染。尽管在生产过程中进行了广泛的控制和检查，但外来颗粒物污染仍然是注射用药品召回的主要原因。玻璃颗粒是最常见的颗粒物类型之一；然而，其产生机制尚未得到广泛研究。实验室模拟表明，在灌装过程中，玻璃瓶之间的常规接触会产生大量玻璃颗粒。为解决这一机制问题，提出了一种具有低摩擦系数表面的新型强化玻璃瓶。实验室模拟和多次灌装线试验表明，使用这种新瓶可大幅减少玻璃颗粒物的产生和产品污染。这些结果表明，这种新瓶通过消除玻璃颗粒产生的根源降低了污染风险。
