VHP Sterilization of Pre-Filled Syringes With Cold-Spot Condensation Control
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Solution Overview
Problem
Existing sterilization methods using vaporized hydrogen peroxide (VHP) face challenges in achieving complete sterilization of medical products like pre-filled syringes without damaging them, due to temperature sensitivity, pressure sensitivity, and inefficiencies in sterilization cycles, while also posing health risks from residual chemicals.
Innovation Solution
A controlled sterilization system and method using vaporized hydrogen peroxide (VHP) that maintains a balanced temperature differential to promote preferential condensation on 'cold spots' within the load, ensuring thorough sterilization and efficient removal of residual chemicals, utilizing a controlled environment with adjustable temperature, pressure, and gas circulation to optimize VHP distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If vaporized hydrogen peroxide (VHP) sterilization is used to achieve complete sterilization, then sterilization efficacy is improved, but product damage increases due to temperature and pressure sensitivity
Solution Approach 1:
The patent applies parameter changes by precisely controlling temperature, pressure, and humidity parameters during the VHP sterilization process. The system dynamically adjusts these parameters to maintain optimal sterilization conditions while preventing excessive thermal or pressure stress on temperature-sensitive and pressure-sensitive medical products, thereby resolving the contradiction between sterilization efficacy and product damage.
Solution Approach 2:
The patent implements beforehand cushioning by using pre-conditioning cycles that gradually acclimate products to sterilization conditions before full VHP exposure. This gradual approach cushions products against sudden temperature and pressure changes, reducing thermal shock and pressure stress while ensuring complete sterilization is ultimately achieved.
2Reliability
If conventional VHP sterilization cycles are used to ensure thorough sterilization, then sterilization completeness is improved, but cycle time increases leading to reduced productivity
Solution Approach 1:
The patent applies periodic action by using cyclic sterilization protocols with alternating phases of VHP exposure, aeration, and conditioning. This periodic approach maintains thorough sterilization through repeated exposure cycles while reducing total time compared to continuous conventional cycles, thereby improving productivity without compromising sterilization completeness.
Solution Approach 2:
The patent implements continuity of useful action by optimizing the VHP sterilization process to maintain effective sterilization conditions throughout the entire cycle without unnecessary interruptions. The system continuously monitors and maintains optimal parameters, eliminating idle time while ensuring complete sterilization, thus reducing cycle time and increasing productivity.
3Reliability
If VHP sterilization is used to sterilize medical products, then sterilization effectiveness is improved, but residual chemicals remain posing health risks
Solution Approach 1:
The patent applies the extraction principle by implementing dedicated aeration and removal cycles that actively extract and eliminate VHP residues from the sterilization chamber and from product surfaces. This systematic removal process ensures complete elimination of harmful residual chemicals while maintaining sterilization effectiveness, thereby resolving the contradiction between sterilization effectiveness and residual chemical presence.
4Productivity
If high concentration VHP is used to achieve rapid sterilization, then sterilization speed is improved, but product damage increases due to aggressive chemical action
Solution Approach 1:
The patent applies local quality by creating heterogeneous VHP concentration distributions within the sterilization chamber. Different regions experience optimized local concentrations tailored to their specific sterilization needs, allowing rapid sterilization in critical areas while using lower concentrations in regions where high concentration would cause product damage, thus balancing sterilization speed with product protection.
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
Achieves 100% sterilization of medical products with complete removal of VHP residues, enhancing safety and efficiency by minimizing cycle time and reducing product damage, while maintaining effective sterilization efficacy.
Implementation Method 1
maintains a balanced temperature differential to promote preferential condensation on 'cold spots' within the load
Implementation Method 2
sterilization of medical products, including terminal sterilization of pre-filled syringes (or other pre-filled drug delivery devices) using vaporized chemicals, such as vaporized hydrogen peroxide
Data Source
AI summary
Embodiments of the present disclosure relate to systems and methods for the application of vaporized chemicals in the sterilization of medical products. For example, embodiments of the present disclosure may relate to systems and methods for the terminal sterilization of medical products using vaporized hydrogen peroxide (VHP). Embodiments of the present disclosure may relate to, e.g., systems and methods for the terminal sterilization of medical products, such as pre-filled syringes (PFS).