Frangible Seal Pouch for Clean Room Drug Deactivation
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Solution Overview
Problem
Existing clean room sterilization methods fail to adequately deactivate hazardous drugs on surfaces, spreading them instead, and chemicals capable of deactivation cannot be irradiated, complicating introduction into clean rooms.
Innovation Solution
A deactivation wipe kit with three pouches containing wipes saturated in specific chemicals (hypochlorite, thiosulfate, and isopropyl alcohol) is designed, allowing irradiation outside the clean room and aseptic filling inside, ensuring compliance with USP standards for surface deactivation, decontamination, and disinfection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods are used in clean rooms, then sterilization is achieved, but hazardous drugs are not adequately deactivated and are simply spread around
Solution Approach 1:
The wipe kit is divided into three separate pouches, each containing a different chemical composition (hypochlorite, thiosulfate, and isopropyl alcohol). This segmentation allows each chemical to perform its specific function in the deactivation sequence without interfering with others, ensuring proper hazardous drug deactivation while maintaining sterilization effectiveness.
Solution Approach 2:
The pouches are pre-filled with specific chemical compositions outside the clean room and terminally sterilized by irradiation before use. This preliminary preparation ensures that the chemicals are ready for immediate use in the clean room without requiring further preparation, maintaining both sterilization and deactivation capabilities.
2Object-affected harmful factors
If chemicals capable of deactivating hazardous drugs are used, then deactivation is achieved, but the chemicals cannot be irradiated and cannot be introduced into clean rooms
Solution Approach 1:
The pouches are pre-filled with chemical compositions outside the clean room and terminally sterilized by irradiation before use. This preliminary sterilization ensures the chemicals are sterile when introduced into the clean room environment.
Solution Approach 2:
The pouch structure acts as an intermediary barrier that allows the chemicals to be sterilized by irradiation while protecting them from direct exposure to the clean room environment. The pouch material is selected to be compatible with both the chemicals and the sterilization process, enabling introduction into the clean room without compromising sterility or chemical integrity.
3Reliability
If chemical compositions are sterilized before entering the clean room, then contamination risk is reduced, but the sterilization process becomes complicated for chemicals that cannot be irradiated
Solution Approach 1:
The pouches are pre-filled with chemical compositions outside the clean room and terminally sterilized by irradiation before use. This preliminary sterilization simplifies the process by ensuring sterility is achieved before the chemicals enter the clean room environment.
Solution Approach 2:
The pouches are designed as disposable single-use items that are pre-sterilized. This eliminates the need for complex re-sterilization processes within the clean room, as each pouch is independently sterilized and discarded after use, reducing both complexity and contamination risk.
4Productivity
If concentrated chemical composition is terminally sterilized by irradiation, then sterilization is efficient, but certain chemicals cannot be irradiated due to their chemical makeup
Solution Approach 1:
The kit is segmented into three pouches, each containing a different chemical composition that is compatible with terminal irradiation sterilization. This segmentation allows selection of chemicals that can withstand irradiation while still providing the required deactivation functions.
Solution Approach 2:
The chemical compositions are formulated with specific concentrations and formulations that are compatible with terminal irradiation sterilization. By adjusting the chemical parameters (concentration, formulation), the chemicals can withstand the irradiation process while maintaining their deactivation 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 wipe kit effectively deactivates, decontaminates, and disinfects hazardous drugs in clean rooms, maintaining surface integrity and compliance with USP standards, while preventing contamination and ensuring worker safety.
Implementation Method 1
the frangible seal can be broken to allow the liquid in the first compartment to come into contact with the wiper in the second compartment
Implementation Method 2
A laser score can be formed along at least a portion of the second compartment, here shown extending transversely across the entire width of the pouch
Implementation Method 3
The pouch is formed by heat sealing the layers 270, 272 along their two longitudinal sides
Implementation Method 4
The entire pouch 250, including the contents, can then be sterilized by irradiation
Data Source
Figure 1~2
Figure 3A~3E
Figure 4~5
AI summary
A wipe kit includes a pouch having a first compartment with a one-way valve coupled to an end thereof, a second compartment, and a frangible seal between the first and second compartments. The first compartment receives a liquid through the one-way valve and the second compartment contains a dry wipe. The frangible seal can be broken to permit liquid to flow from the first compartment onto the wipe in the second compartment. The deactivation wipe kit may be used in a clean room to deactivate most hazardous drugs on a work surface.