Gas-Tight Coated Plastic Primary Packaging for Medical Preparations
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Solution Overview
Problem
Primary packagings for medical preparations, particularly those used for ophthalmic injections, face challenges with maintaining sterility and preventing contamination from chemical sterilization agents due to material permeability and the risk of microscopic glass particles from glass materials, while plastic alternatives are gas-permeable and difficult to sterilize effectively.
Innovation Solution
A primary packaging made from plastic with a gas-tight coating on its outer surface, using materials like metal or metalloid films, silicon compounds, or Teflon, which is impermeable to sterilization agents, ensuring outer sterility and preventing agent ingress, and optionally featuring an inner gas-tight coating and functional layers for enhanced properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If glass is used for primary packaging, then outer sterility can be achieved, but development and control effort increases significantly and risk of microscopic glass particles detaching remains
Solution Approach 1:
The patent uses a composite structure combining plastic base material with a silicon oxide coating layer. The plastic provides structural integrity and chemical resistance, while the silicon oxide coating provides gas tightness and sterility protection, eliminating glass particles while maintaining sterilization effectiveness.
Solution Approach 2:
The patent employs a disposable plastic primary packaging with integrated coating, replacing expensive and complex glass packaging. The plastic packaging is designed for single use, eliminating the need for repeated sterilization cycles and complex control procedures associated with glass packaging.
2Ease of operation
If glass is siliconized to improve sliding properties, then plug movement is improved, but quantity of subvisual particles increases
Solution Approach 1:
The patent applies a thin silicon oxide coating layer on the plastic surface that provides the necessary sliding properties for plug movement without introducing glass particles. The coating is applied in controlled amounts during manufacturing, ensuring adequate lubrication while minimizing particle generation.
3Ease of manufacture
If highly transparent plastics are used for primary packaging, then manufacturing is easier and particle risk is reduced, but gas permeability prevents effective chemical sterilization
Solution Approach 1:
The patent combines transparent plastic material with a silicon oxide coating layer. The plastic provides ease of manufacture and transparency, while the silicon oxide coating provides gas tightness that prevents penetration of chemical sterilization agents like ethylene oxide and vaporized hydrogen peroxide, enabling effective sterilization.
4Device complexity
If plastic material is used without coating, then development effort is reduced, but chemical sterilization agents penetrate into the packaging
Solution Approach 1:
The silicon oxide coating acts as an intermediary barrier between the plastic packaging and chemical sterilization agents. It prevents direct contact and penetration of sterilization agents into the plastic material, while allowing the packaging structure to remain relatively simple.
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 solution significantly reduces subvisible particles, lowers development and control efforts, and prevents microscopic particle detachment, while ensuring effective chemical sterilization and maintaining sterility, thus addressing the limitations of glass and permeable plastic packagings.
Implementation Method 1
the outer surface is provided with a gas tight coating... the primary packaging is sufficiently sealed against an ingress of these reagents on account of the gas tight coating of the outer surface
Implementation Method 2
the gas tight coating has properties impermeable to oxygen, carbon dioxide, ethylene oxide, and/or hydrogen peroxide
Data Source
AI summary
A primary packaging for medical preparations includes a base body having a plastic material. The base body has at least one wall including an outer surface and at least one inner surface. The outer surface of the primary packaging is provided with a gas tight coating.