Sterilizable Flexible Package Gas Perforation Valve
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Solution Overview
Problem
Current sterilization processes for flexible packages used for reconstituting and administering medicinal or nutritional substances within the body are costly and complex, requiring specialized chambers.
Innovation Solution
A sterilization process involving the introduction of a mixture of sterilizing gas and oxygen into the package casing through a connector with a non-return valve, allowing the mixture to act for a period before removal, potentially creating a vacuum, to ensure sterility without the need for expensive sterilization chambers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sterilization chambers are used, then sterilization effectiveness is ensured, but manufacturing cost and process complexity increase significantly
Solution Approach 1:
The invention extracts the sterilization function from complex sterilization chambers and implements it through a simple gas delivery system. A connector with non-return valve introduces sterilizing gas directly into the casing, eliminating the need for expensive sterilization equipment while maintaining sterilization effectiveness.
Solution Approach 2:
The invention uses gas phase sterilization through a connector system. Sterilizing gas is introduced into the casing through a connector with non-return valve, allowing pneumatic delivery of sterilant without mechanical complexity. The gas displaces air and achieves sterilization through chemical action rather than thermal or mechanical processes.
2Ease of manufacture
If sterilizing gas is introduced through a simple connector, then manufacturing cost decreases, but ensuring complete sterilization and preventing contamination becomes more difficult
Solution Approach 1:
The non-return valve acts as an intermediary element that ensures unidirectional flow of sterilizing gas into the casing while preventing backflow of contaminated air. This simple mechanical component maintains sterility reliability without adding significant manufacturing complexity.
Solution Approach 2:
The invention changes the physical parameters of the sterilization process by using gas phase sterilization with controlled introduction and removal. The sterilizing gas is introduced, allowed to act for a period, then removed potentially creating vacuum, which prevents contamination upon opening. This parameter-based approach ensures complete sterilization while maintaining simplicity.
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
This method simplifies and reduces the cost of sterilization while maintaining sterility, making the process more accessible and efficient for flexible packages.
Implementation Method 1
introducing a mixture of sterilizing gas and oxygen into said casing through a connector provided with a non-return valve, leaving the mixture of sterilizing gas and oxygen inside the casing for a certain period of time
Implementation Method 2
introducing a mixture of sterilizing gas and oxygen into said casing through a connector provided with a non-return valve
Implementation Method 3
removing the mixture of sterilizing gas and oxygen from said casing through the connector provided with a cap with non-return valve, possibly creating a vacuum inside the casing
Data Source
AI summary
There is described a package for the reconstitution and administration of fluid medicinal or nutritional substances which are infused or instillable within the body of a patient, comprising a flexible casing containing a vial of a medicinal or nutritional substance in a coupling position to a coupling and perforation device inserted into a mixing tube for the connection with a bag of liquid diluent. The casing comprises a connector provided with an openable and hermetically closable cap, adapted to introduce a mixture of sterilizing gas and oxygen into said casing.