Integrated Sterilization and Drying Chamber for Bioresorbable Products
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Solution Overview
Problem
Current methods for ethylene oxide sterilization of bioresorbable products require separate handling and processing steps, including drying, which are time-consuming and prone to handling errors and recontamination.
Innovation Solution
A method and device that integrates conditioning, sterilization, post-conditioning, and drying in a single chamber, utilizing a process vacuum pump for air removal and water vapor introduction, followed by a high-vacuum pump for deep vacuum drying, allowing for continuous processing without the need for separate handling and minimizing moisture and contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If drying is carried out in a separate drying chamber, then the sterilization and drying processes can be performed independently, but the items must be removed from the sterilization chamber and transferred to the drying chamber, which increases handling steps and time
Solution Approach 1:
The patent combines the sterilization chamber and drying chamber into a single integrated chamber. After sterilization, the chamber is evacuated to remove ethylene oxide and moisture, then drying gas is introduced to achieve the desired moisture content. This eliminates the need to transfer items between chambers, preventing recontamination while reducing handling time.
Solution Approach 2:
The sterilization chamber is designed to perform multiple functions: sterilization with ethylene oxide, evacuation to remove gases and moisture, and drying with introduced drying gas. This multi-functional design allows the same chamber to handle both sterilization and drying operations without requiring separate dedicated chambers.
2Reliability
If multiple separate chambers are used for sterilization and drying, then each process can be optimized independently, but the complexity of the device increases
Solution Approach 1:
The patent merges the sterilization and drying chambers into a single chamber, reducing the overall number of chambers from two to one. This simplifies the device structure while maintaining independent control of the sterilization and drying processes through sequential operation and different gas introductions.
3Productivity
If items are transferred between chambers, then separate processing can be achieved, but handling errors and recontamination risks increase
Solution Approach 1:
By combining sterilization and drying in one chamber, the patent eliminates the transfer step entirely. Items remain in the same chamber throughout the entire process, preventing handling errors and recontamination risks that would occur during transfer between separate chambers.
Solution Approach 2:
The patent implements a continuous process where sterilization is followed immediately by evacuation and drying in the same chamber without interruption or transfer. This continuous operation maintains the sterile environment and eliminates breaks in the process where contamination could occur.
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
Significantly reduces the overall processing time by 82% from 84 hours to approximately 15 hours, eliminating handling errors and recontamination risks while ensuring bioresorbable products are thoroughly dried and ready for use.
Implementation Method 1
Evacuate the chamber with a process vacuum pump to remove air to 50-100 mbar
Implementation Method 2
introduce water vapor at a temperature of 35-60°C (adjustable) for conditioning the items to be sterilized
Implementation Method 3
the high-vacuum pump creates a vacuum of less than 4x10 -3 mbar. By creating this vacuum, the moisture that is still present in the bioresorbable product is further evaporated
Implementation Method 4
Evacuation of the ethylene oxide gas mixture over a catalyst to convert the ethylene oxide into CO 2 and water
Data Source
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AI summary
The invention relates to a method for sterilizing bioresorbable products using ethylene oxide, comprising the following steps: packaging a bioresorbable product in a sterilization bag or film; placing the packaged product (15) into the chamber of a sterilizer (1); evacuating the chamber (1) with the vacuum pump (2) to 50-100 mbar to remove air; introducing steam (14) at a temperature of 35-60°C to condition the product; introducing a gas mixture consisting of 6-15% ethylene oxide and inert gas (13) up to an overpressure of up to 3,500 mbar abs.For sterilization; the item to be sterilized (15) remains in the sterilization chamber (1) for a period of 15 minutes to 10 hours, preferably 1 to 4 hours, at a temperature of 35–60°C; evacuation of the ethylene oxide gas mixture via a catalyst (9) to convert the ethylene oxide into CO2 and water; initiation of desorption with alternating cyclic air purge-vacuum cycles, the evacuation pressure being between 30 and 200 mbar; re-evacuation with the process vacuum pump (2); filling of the chamber with inert gas up to a pressure of 100–500 mbar abs. The process is characterized in that, after the purge with inert gas, the process vacuum pump (2) is deactivated and the high-vacuum pump (3) is activated; whereby a vacuum of less than 4 x 10⁻³ mbar is generated in the sterilization chamber (1); Flooding the sterilization chamber with nitrogen until atmospheric pressure is reached; removal of the sterile bioresorbable product (16).