TY - JOUR
T1 - Performance stability of silicone oxide-coated plastic parenteral vials
AU - Weikart, Christopher M.
AU - Pantano, Carlo G.
AU - Shallenberger, Jeff R.
N1 - Publisher Copyright:
©PDA, Inc. 2017.
PY - 2017/7/1
Y1 - 2017/7/1
N2 - 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.
AB - 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.
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U2 - 10.5731/pdajpst.2016.007278
DO - 10.5731/pdajpst.2016.007278
M3 - Article
C2 - 28416645
AN - SCOPUS:85026424487
SN - 1079-7440
VL - 71
SP - 317
EP - 327
JO - PDA Journal of Pharmaceutical Science and Technology
JF - PDA Journal of Pharmaceutical Science and Technology
IS - 4
ER -