Weikart Christopher M, Pantano Carlo G, Shallenberger Jeff R
SiO2 Medical Products Inc., Auburn, AL; and
The Pennsylvania State University, The Department of Materials Science and Engineering, University Park, PA.
PDA J Pharm Sci Technol. 2017 Jul-Aug;71(4):317-327. doi: 10.5731/pdajpst.2016.007278. Epub 2017 Apr 17.
A new packaging system was developed for parenteral pharmaceuticals that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high-precision injection-molded plastics and plasma coating technology. The result is a shatter-resistant, optically clear, low-particulate, and chemically durable packaging system. The demand for this product is driven by the expanding market, regulatory constraints, and product recalls for injectable drugs and biologics packaged in traditional glass materials. It is shown that this new packaging system meets or exceeds the important performance characteristics of glass, especially in eliminating the glass delamination and breakage that has been observed in many products. The new packaging system is an engineered, multilayer, glass-coated plastic composite that provides a chemically stable contact surface and oxygen barrier performance that exceeds a 2 year shelf life requirement. Evaluation of the coating system characteristics and performance stability to chemical, temperature, and mechanical extremes are reported herein. A new packaging system for parenteral pharmaceuticals was developed that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high-precision injection-molded plastics and plasma coating technology. The result is a shatter-resistant, optically clear, low-particulate, and chemically durable packaging system. It is shown that this new packaging system meets or exceeds the important performance characteristics of glass, especially in eliminating the glass delamination and breakage that has been observed in many products. The new packaging system is an engineered, multilayer, glass-coated plastic composite that provides a chemically stable contact surface and oxygen barrier performance that exceeds a 2 year shelf life requirement. Evaluation of the coating system characteristics and performance stability to chemical, temperature, and mechanical extremes are reported herein.
一种用于肠胃外药物的新型包装系统被开发出来，它结合了塑料和玻璃的最佳特性，同时又没有它们各自的缺点。这一技术进步基于高精度注塑塑料和等离子体涂层技术之间的协同作用。其结果是一种抗破碎、光学透明、低颗粒且化学耐用的包装系统。对这种产品的需求受到不断扩大的市场、监管限制以及用传统玻璃材料包装的注射用药物和生物制品的产品召回等因素的推动。结果表明，这种新型包装系统达到或超过了玻璃的重要性能特征，尤其是在消除许多产品中观察到的玻璃分层和破碎方面。这种新型包装系统是一种经过精心设计的多层玻璃涂层塑料复合材料，它提供了一个化学稳定的接触表面和超过两年保质期要求的氧气阻隔性能。本文报道了对涂层系统特性以及其在化学、温度和机械极端条件下的性能稳定性的评估。一种用于肠胃外药物的新型包装系统被开发出来它结合了塑料和玻璃的最佳特性，同时又没有它们各自的缺点。这一技术进步基于高精度注塑塑料和等离子体涂层技术之间的协同作用。其结果是一种抗破碎、光学透明、低颗粒且化学耐用的包装系统。结果表明，这种新型包装系统达到或超过了玻璃的重要性能特征，尤其是在消除许多产品中观察到的玻璃分层和破碎方面。这种新型包装系统是一种经过精心设计的多层玻璃涂层塑料复合材料，它提供了一个化学稳定的接触表面和超过两年保质期要求的氧气阻隔性能。本文报道了对涂层系统特性以及其在化学、温度和机械极端条件下的性能稳定性的评估。
