Liquid Sterilization of Pharmaceutical Closures
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Solution Overview
Problem
Existing multi-treatment sterilization devices can damage delicate closures due to clumping and require time-consuming pre-vacuum and steam sterilization processes, which are not effective for all material compositions and may reduce the silicon film on siliconized articles.
Innovation Solution
A multi-treatment sterilization device that submerges articles in liquid during sterilization, using a liquid transfer means to direct the liquid flow and reduce contact forces, allowing for gentle treatment without pre-vacuum, and incorporating silicon oil to enhance the process, enabling heating, sterilization, and cooling treatments while reducing adhesion and clumping risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If closures are sterilized using conventional steam sterilization in a multi-purpose container, then sterilization is achieved, but closures may clump together and be damaged due to contact forces and adhesion
Solution Approach 1:
The patent introduces a liquid medium as an intermediary between the closures and the sterilization environment. The closures are suspended in liquid rather than being in direct contact with each other, which prevents clumping and damage while still allowing effective sterilization to occur through the liquid medium
Solution Approach 2:
The patent uses hydraulic principles by immersing closures in a liquid medium for sterilization. The liquid flow and suspension mechanisms utilize fluid dynamics to keep closures separated and suspended, preventing adhesion and contact damage during the sterilization process
2Reliability
If pre-vacuum and steam sterilization steps are used to sterilize closures, then sterilization is achieved, but the process time is extended
Solution Approach 1:
The patent combines multiple sterilization steps into a single liquid-based sterilization process. By merging the suspension, sterilization, and protection functions into one integrated liquid medium approach, the process time is reduced while maintaining sterilization effectiveness
Solution Approach 2:
The patent skips the traditional pre-vacuum step and rushes through to direct liquid-based sterilization. This eliminates unnecessary time-consuming steps while achieving the same or better sterilization results more efficiently
3Reliability
If closures are siliconized and then subjected to steam sterilization or similar treatments, then sterilization is achieved, but the silicon film on articles is reduced
Solution Approach 1:
The liquid medium serves as a gentle intermediary that allows sterilization to occur without the harsh conditions of steam or vacuum treatments. This protects the silicon film while still achieving effective sterilization through the liquid medium
Solution Approach 2:
The patent changes the physical parameters of the sterilization environment by using liquid instead of gas (steam). This parameter change creates a gentler sterilization condition that preserves the silicon film while maintaining sterilization effectiveness
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 device effectively prevents clumping and damage to delicate articles by reducing contact forces, allowing for efficient and gentle sterilization without pre-vacuum, and maintains the silicon film on siliconized articles, improving the overall sterilization process and reducing process time.
Implementation Method 1
The liquid in itself, in comparison of gas, may reduce the difference between the density of the article and fluid which may at least partly reduce the contact forces between the articles. The articles are effected in accordance with the principle of Archimedes. Thus, the relative weight of the articles may be reduced wherein the articles may be at least partly suspended in the liquid.
Implementation Method 2
The articles are effected in accordance with the principle of Archimedes. Thus, the relative weight of the articles may be reduced wherein the articles may be at least partly suspended in the liquid.
Data Source
AI summary
The apparatus and method for sterilising caps/stoppers for pharmaceutical purposes comprises a vessel, pump, heater, circulation line. The sterilising liquid (hot water, steam) is heated and pumped to the vessel where a fluidised bed of caps etc. is generated. After leaving the vessel the liquid is circulated/heated. Optionally an additive (siliconisation in case rubber parts) or cooling liquid is added. Further, the vessel is disconnectably attached to the supply lines for transportation to a production facility.