Pouch with breakable seal
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Solution Overview
Problem
Conventional clean room sterilization methods fail to adequately deactivate hazardous drugs on surfaces, often spreading the drugs instead of removing them, and products capable of deactivation are not suitable for use in classified ISO 5 clean rooms.
Innovation Solution
A deactivation wipe kit with multiple compartments separated by frangible seals, containing wipes saturated with specific chemicals such as hypochlorite, thiosulfate, and isopropyl alcohol, designed for sequential use to deactivate, decontaminate, and disinfect hazardous drugs from surfaces in clean rooms.
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 spread instead of deactivated
Solution Approach 1:
The pouch is divided into multiple compartments separated by frangible seals, with each compartment containing a different chemical composition (e.g., hypochlorite, thiosulfate, isopropyl alcohol). This segmentation allows sequential application of different chemicals to deactivate, decontaminate, and disinfect hazardous drugs without spreading them, while maintaining sterilization effectiveness in the clean room environment.
2Object-generated harmful factors
If products capable of deactivating hazardous drugs are used, then deactivation is achieved, but they are not suitable for use in classified ISO 5 clean rooms
Solution Approach 1:
The pouch is pre-assembled with multiple compartments containing different chemical compositions outside the clean room, then terminally sterilized by irradiation as a complete unit. This preliminary assembly and sterilization allows the deactivation products to be introduced into the classified ISO 5 clean room in a pre-sterilized state, making them suitable for use while maintaining both deactivation capability and clean room compatibility.
3Reliability
If chemical compositions are sterilized by filtration inside the clean room, then sterilization is achieved, but it complicates the introduction process
Solution Approach 1:
The pouch is assembled and terminally sterilized by irradiation outside the clean room before introduction. This preliminary sterilization eliminates the need for complex filtration procedures inside the clean room, simplifying the introduction process while ensuring sterilization reliability.
4Productivity
If concentrated composition is terminally irradiation sterilized, then sterilization efficiency is improved, but chemicals with certain makeup cannot be irradiated
Solution Approach 1:
The pouch is segmented into multiple compartments, each containing different chemical compositions that are compatible with irradiation sterilization. This segmentation allows the selection of irradiation-compatible chemicals (such as hypochlorite, thiosulfate, and isopropyl alcohol) while maintaining sterilization efficiency through terminal irradiation of the complete pouch.
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 and removes hazardous drugs from surfaces in clean rooms, meeting USP compliance standards, while allowing for efficient sterilization and introduction into classified environments.
Implementation Method 1
the seal is broken by application of force to a break point of the seal
Implementation Method 2
a first wipe in the second compartment is saturated with a hypochlorite solution
Implementation Method 3
a second wipe in the second compartment is saturated with a thiosulfate solution
Implementation Method 4
a third wipe in the second compartment is saturated with isopropyl alcohol
Data Source
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.