Deactivation Wipe Kit with Sequential Chemical Solutions
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Solution Overview
Problem
Conventional methods for deactivating, decontaminating, and disinfecting hazardous drugs in clean room environments are inadequate, as they either spread the drugs instead of deactivating them or are not suitable for use in classified ISO 5 clean rooms, and certain chemicals cannot be irradiated for sterilization.
Innovation Solution
A deactivation wipe kit comprising three pouches with wipes saturated in 5.25% hypochlorite solution, 2% thiosulfate, and 70% isopropyl alcohol, designed for sequential use to deactivate, decontaminate, and disinfect surfaces, with the first pouch containing sodium hypochlorite that cannot be irradiated and the others terminally sterilized, and a one-way valve for aseptic filling within the clean room.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods are used, then sterilization is achieved, but hazardous drugs are spread instead of deactivated
Solution Approach 1:
The deactivation process is segmented into three distinct sequential steps using three different wipes: (1) sodium hypochlorite wipe for deactivation, (2) thiosulfate wipe for neutralization, and (3) isopropyl alcohol wipe for disinfection. This segmentation allows each chemical to perform its specific function without spreading hazardous drugs, as each wipe is applied in a controlled sequence that ensures proper deactivation before cleaning.
2Object-generated harmful factors
If chemicals capable of deactivating hazardous drugs are used, then deactivation is achieved, but they are not suitable for use in ISO 5 clean rooms
Solution Approach 1:
The patent introduces sterile containers and sterile transfer techniques as intermediaries to bridge the gap between non-sterile deactivation chemicals and sterile clean room requirements. The sodium hypochlorite solution is prepared outside the clean room in non-sterile conditions, then transferred through a sterile barrier (sterile container with sterile adapter) into the clean room environment, allowing the use of effective deactivation chemicals without compromising clean room sterility.
Solution Approach 2:
The preparation and mixing of deactivation chemicals is extracted from the clean room environment and performed outside in non-sterile areas. Only the final sterile products (pre-mixed solutions in sterile containers) are introduced into the ISO 5 clean room, separating the non-sterile preparation process from the sterile application process.
3Reliability
If concentrated chemical compositions are sterilized by irradiation, then sterilization is achieved, but certain chemicals cannot be irradiated due to their chemical makeup
Solution Approach 1:
The sterilization step is extracted from the chemical preparation process. Instead of attempting to sterilize all chemicals by irradiation (which damages certain chemicals), the patent uses irradiation to sterilize the container and cap, then introduces the non-irradiated chemical solution through a sterile barrier, separating the sterilization function from the chemical treatment function.
Solution Approach 2:
A sterile barrier (sterile container with sterile adapter) acts as an intermediary that allows non-sterile chemical solutions to be introduced into a sterile environment without requiring the chemicals themselves to be sterilized by irradiation. The barrier maintains sterility while permitting the introduction of chemicals that are sensitive to irradiation.
4Object-affected harmful factors
If chemical compositions are sterilized before entering the clean room, then contamination risk is reduced, but the sterilization process complicates introduction of certain chemicals
Solution Approach 1:
The sterile container and adapter system serves as an intermediary that simplifies the overall process by allowing chemicals to be introduced without complex sterilization procedures. The pre-sterilized container acts as a barrier that maintains sterility while permitting easy introduction of non-sterile chemical solutions, reducing both contamination risk and process complexity.
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
Effectively deactivates and disinfects hazardous drugs while maintaining surface integrity and compliance with USP standards, allowing safe handling and preparation of sterile products in ISO 5 clean rooms, and enables efficient sterilization and introduction into clean room environments.
Implementation Method 1
a first wipe material saturated in a first solution, such as 5.25% hypochlorite
Implementation Method 2
a second wipe material saturated in a second solution, such as 2% thiosulfate
Implementation Method 3
a third wipe material saturated in a third solution, such as 70% isopropyl alcohol
Implementation Method 4
the first closed or sealed container or pouch includes a one-way valve
Data Source
AI summary
A hazardous drug deactivation wipe kit includes a first pouch having a one-way valve coupled to an end thereof, a second pouch, and a third pouch. The first pouch contains a wipe saturated in a hypochlorite solution, the second pouch contains a wipe saturated in thiosulfate solution, and the third pouch contains a wipe saturated in isopropyl alcohol solution. The deactivation wipe kit may be used in a clean room to deactivate most hazardous drugs on a work surface.