RT Journal Article
SR Electronic
T1 PERFORMANCE STABILITY OF SILICON OXIDE COATED PLASTIC PARENTERAL VIALS
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2016.007278
DO 10.5731/pdajpst.2016.007278
A1 Weikart, Christopher M
A1 Pantano, Carlo G
A1 Schallenberger, Jeff R
YR 2017
UL http://journal.pda.org/content/early/2017/04/13/pdajpst.2016.007278.abstract
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 two year shelf life requirement. Evaluation of the coating system characteristics and performance stability to chemical, temperature and mechanical extremes are reported herein.