Sterilisation Bag Pressure Compensation
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Solution Overview
Problem
Current sterilization methods face challenges in ensuring consistent and reproducible sterilization of diverse loads due to variations in loading and packaging, leading to potential recontamination and inefficient sterilization cycles, with existing technologies struggling to maintain sterility and protect contents effectively during handling, transportation, and storage.
Innovation Solution
A method and apparatus utilizing a sterilization bag with a large opening for item placement, evacuated before sterilization, and maintained at above-atmospheric pressure during steam sterilization, combined with external heating plates for efficient drying, and a sealing mechanism to ensure sterility and integrity, along with RFID tracking for validation and traceability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilisation methods using pressurised high temperature steam in a pressure chamber are used, then sterilisation effectiveness is improved, but cycle time is extended and recontamination risk increases
Solution Approach 1:
The sterilisation process is segmented into distinct phases: evacuation phase, sterilisation phase, and sealing phase. The sterilisation bag is separated from the chamber environment, allowing independent control of each phase. This segmentation enables faster cycle times while maintaining sterilisation effectiveness by eliminating the need for lengthy chamber-wide air removal and sealing operations.
Solution Approach 2:
The sterilisation bag is evacuated and sealed before placing items inside, performing critical air removal and sealing actions in advance. This preliminary action eliminates the need for post-sterilisation chamber sealing and reduces overall cycle time while ensuring sterility is established before item placement.
2Reliability
If breathable packaging is used to allow steam passage during sterilisation, then sterilisation penetration is improved, but protection against recontamination deteriorates
Solution Approach 1:
The packaging transitions from a breathable state during sterilisation to a sealed impermeable state after sterilisation. The bag material dynamically changes its permeability properties - allowing steam penetration during the sterilisation phase, then forming an impermeable barrier after sealing to prevent recontamination during storage and transport.
Solution Approach 2:
The packaging's permeability parameter is changed through the sealing process. Before sealing, the bag allows steam passage for effective sterilisation. After sealing, the impermeable barrier property is activated, transforming the packaging from permeable to impermeable to prevent recontamination while maintaining sterilisation effectiveness.
3Manufacturing precision
If multiple air removal and pre-heating cycles are performed, then sterilisation uniformity is improved, but productivity decreases
Solution Approach 1:
Air removal and pre-heating actions are extracted from the main sterilisation cycle and performed separately before item placement. The bag is evacuated and pre-heated independently, then items are added and the bag sealed. This extraction eliminates the need for repeated air removal cycles during sterilisation, improving throughput while maintaining uniformity through the initial pre-heating phase.
4Reliability
If complex validation and monitoring systems are implemented, then sterility assurance is improved, but device complexity increases
Solution Approach 1:
The sterilisation bag provides self-validation through its design features. The impermeable barrier property inherently prevents recontamination, serving as a built-in validation mechanism. The sealing process itself acts as a monitoring point, with the sealed bag providing visual and physical confirmation of sterility maintenance without requiring complex external monitoring systems.
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
This approach ensures effective sterilization with reduced cycle times, enhanced sterility maintenance, and extended shelf life, minimizing recontamination risks while providing immediate visual indication of package integrity, thus addressing the limitations of traditional methods.
Implementation Method 1
The sterilisation bag is evacuated before items are placed inside
Implementation Method 2
Steam is the most widely used agent for sterilisation. In steam sterilisation, the combination of heat and moisture, maintained at a pre-set temperature-pressure-time relationship, coagulates cell protein, efficiently killing the microorganisms
Implementation Method 3
the combination of heat and moisture, maintained at a pre-set temperature-pressure-time relationship
Implementation Method 4
combined with external heating plates for efficient drying
Implementation Method 5
a sealing mechanism to ensure sterility and integrity
Implementation Method 6
maintained at a pre-set temperature-pressure-time relationship
Data Source
Figure 1
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Figure 3~4
AI summary
A method of sterilizing items by placing items to be sterilized into a puncture resistant sealable vapor barrier sterilization bag, performing steam sterilization under pressure via a conduit coupled to the bag while maintaining a heated compensating pressure environment around the exterior of the bag during steam sterilization so as to reduce mechanical stress on the bag and sealing the bag at the completion of sterilization. There is also provided a sterilization services apparatus for sterilizing the contents of a sterilization bag including a pressure compensating compartment having a sealable door that maintains a heated compensating pressure environment around the exterior of a sterilization bag during steam sterilization so as to reduce mechanical stress on the bag.