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Performance Stability of Silicone Oxide-Coated Plastic Parenteral Vials
Christopher M Weikart1, Carlo G Pantano2, Jeff R Shallenberger2
1SiO2 Medical Products Inc., Auburn, AL; and christopher.weikart@sio2med.com.
PDA Journal of Pharmaceutical Science and Technology
|April 19, 2017
Summary
A novel parenteral pharmaceutical packaging system merges plastic and glass benefits, offering shatter resistance and chemical durability. This advanced packaging overcomes glass limitations, ensuring product integrity and extended shelf life.
Area of Science:
- Materials Science
- Pharmaceutical Packaging
- Coating Technology
Background:
- Traditional glass parenteral packaging faces challenges like delamination and breakage.
- Expanding pharmaceutical markets and regulatory demands necessitate improved packaging solutions.
- Product recalls highlight the risks associated with conventional glass containers for injectables.
Purpose of the Study:
- To develop an advanced packaging system for parenteral pharmaceuticals.
- To combine the advantages of plastic and glass while mitigating their respective drawbacks.
- To create a packaging solution that enhances product stability and safety.
Main Methods:
- Utilizing high-precision injection-molded plastics.
- Applying plasma coating technology to create a multilayer composite.
- Engineering a glass-coated plastic material for pharmaceutical containment.
Main Results:
- The new system is shatter-resistant, optically clear, and low-particulate.
- It demonstrates superior chemical durability compared to traditional materials.
- The packaging meets or exceeds glass performance, preventing delamination and breakage.
- It provides a chemically stable contact surface and oxygen barrier exceeding 2-year shelf life.
Conclusions:
- The developed packaging system offers a significant advancement for parenteral pharmaceuticals.
- It effectively addresses the limitations of traditional glass packaging.
- This innovative solution ensures enhanced product integrity and extended shelf life.

