PECVD Passivation Coating for Low-Leachable Pharmaceutical Packages
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Solution Overview
Problem
Existing pharmaceutical packages, particularly glass and plastic vessels, face issues such as contamination, delamination, breakage, gas permeability, water vapor transmission, and leachables, which affect the shelf life and stability of biologics and therapeutics, especially in complex delivery systems like auto-injectors.
Innovation Solution
A passivation layer and pH protective coating comprising SiOxCy or SiNxCy is applied using chemical vapor deposition, enhancing the barrier and lubricity properties of plastic syringes and glass surfaces to prevent leaching and erosion, maintaining the integrity of the contents over an extended shelf life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If glass vessels are used for pharmaceutical packaging, then strength and impermeability are improved, but leachables and contamination risks increase
Solution Approach 1:
A silicon oxide barrier coating is applied to the glass vessel surface to act as an intermediary layer between the glass and the pharmaceutical contents. This coating prevents direct contact between the glass and the drug solution, thereby eliminating leachables while maintaining the strength and impermeability of the glass vessel.
Solution Approach 2:
The invention creates a composite structure combining glass vessel wall with a silicon oxide coating layer. This composite material system leverages the strength of glass and the chemical inertness of silicon oxide to simultaneously achieve mechanical strength and elimination of leachables.
2Strength
If plastic vessels are used for pharmaceutical packaging, then breakage is reduced, but gas permeability and water vapor transmission increase
Solution Approach 1:
A silicon oxide barrier coating is applied to the plastic vessel surface to act as an intermediary layer that blocks gas and water vapor transmission. This coating provides the barrier properties typically associated with glass while maintaining the breakage resistance of plastic vessels.
Solution Approach 2:
The invention creates a composite structure combining plastic vessel wall with a silicon oxide coating layer. This composite material system leverages the flexibility and breakage resistance of plastic combined with the barrier properties of silicon oxide to simultaneously achieve low gas permeability and high breakage resistance.
3Duration of action of stationary object
If barrier coatings are applied to prevent leachables, then shelf life is extended, but manufacturing complexity increases
Solution Approach 1:
The invention employs a thin, simple silicon oxide coating that can be applied through straightforward chemical vapor deposition processes. The coating is designed to be minimal in thickness and complexity while providing sufficient protection for the intended shelf life, avoiding unnecessarily complex multi-layer systems.
Solution Approach 2:
The invention optimizes the coating parameters including silicon oxide thickness, deposition temperature, and process duration to achieve the minimum necessary protection level. By carefully controlling these parameters, the coating provides adequate shelf life extension while minimizing manufacturing complexity and processing time.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The coating significantly reduces the ingress of gases and solutes, decreases the dissolution rate of glass, and maintains the structural integrity of plastic syringes, ensuring the stability and reliability of pharmaceutical contents for over six months at 4°C.
Implementation Method 1
A coated pharmaceutical package with a SiOx barrier coating and a SiOxCy or SiNxCy passivation layer, applied by PECVD
Data Source
AI summary
A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.