Sterile Component Wrapping for Contamination-Free Reinsertion
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Solution Overview
Problem
Existing methods for sterilizing components within sterile closed environments, such as those used in pharmaceutical processing machines, expose these components to contamination risks during reinsertion and remounting, as they require transfer through non-sterile zones and rely on hydrogen peroxide vapor processes that may not meet new sterility standards.
Innovation Solution
A method involving double-envelope wrapping and sterilization of components, where a first part in contact with products is sealed within a first envelope, and a second part is exposed through a hole, allowing sterilization of both parts while maintaining the first part isolated until reinsertion, using permeable materials for sterilization fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If components are transferred through special openings or windows to outside the closed environment for washing and sterilization, then sterilization can be performed, but the components are exposed to contamination risks during transfer and reinsertion
Solution Approach 1:
A sterile envelope acts as an intermediary container that holds the component during transfer and reinsertion operations. The envelope is permeable to sterilization fluids but impermeable to contaminants, allowing the component to be sterilized while protected from contamination during handling and transfer through openings in the closed environment.
Solution Approach 2:
The component is divided into two parts: a first part that remains sealed within the sterile envelope and a second part that can be accessed through a hole in the envelope. This segmentation allows the first part to maintain sterility during transfer while the second part can be sterilized through the hole without compromising the sealed first part.
2Reliability
If hydrogen peroxide vapor sterilization is used, then sterilization can be achieved, but it may not meet new sterility standards
Solution Approach 1:
The sterilization process uses sterilization fluids that can penetrate through the permeable envelope material, changing the sterilization approach from vapor-based to fluid-based sterilization. This parameter change in the sterilization method allows compliance with new sterility standards while maintaining effective sterilization of the component.
3Object-affected harmful factors
If the first part is sealed within an envelope, then contamination is prevented, but the envelope must be permeable to sterilization fluids
Solution Approach 1:
The envelope is made from a permeable material that allows sterilization fluids to pass through while blocking contaminants. This porous material property enables the envelope to simultaneously provide contamination protection and allow sterilization fluid penetration, resolving the apparent contradiction between sealing and sterilization requirements.
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
Ensures components remain sterile and protected from contamination during reinsertion, adhering to stringent sterility standards by maintaining the first part sealed and isolated until fully mounted, thus preventing external contamination.
Implementation Method 1
The envelope is made of a material suitable for allowing the passage of the sterilisation fluid and for maintaining sterile conditions internally of the envelope to avoid external contaminations
Data Source
AI summary
The method for sterilising a component of a machine operating in a sterile closed environment, and used for contact with products which are to be processed internally of the closed environment, comprises: sealedly wrapping the first part of the component, destined for contact with the products, internally of a first envelope having a hole at which the second part of the component remains exposed and accessible, which second part is destined to be coupled to a the base or frame present internally of the closed environment, and to wrap the component, partially wrapped in the first envelope, internally of a second envelope and to close the second envelope, and then carry out a sterilisation cycle.