Sterile Metering Device Using Disposable Flexible Containers
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing devices for metered filling of media in the pharmaceutical industry are costly and risk contamination during sterile filling, requiring complex validation processes and high effort to maintain sterility in non-sterile environments.
Innovation Solution
A device with a disposable, sterilizable design that uses a storage container and a measuring container connected by sealed hoses, where the media is transferred by pressure difference without sensors or control valves, allowing for precise filling without contamination, using a lockable outlet for transferring the predetermined volume to a target container.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If disposable sterilizable filling devices are used, then sterility and contamination risk are improved, but device cost and complexity increase
Solution Approach 1:
The filling device is divided into disposable flexible components (bags, hoses) that form a closed sterile system, separated from reusable fixed elements (valves, sensors, brackets). This segmentation allows the sterile portion to be disposed of after use while reusing non-sterile components, maintaining sterility without requiring the entire device to be complex and disposable.
Solution Approach 2:
The flexible components (bags and hoses) are designed as disposable items that are sterilized before use and then discarded after a single filling operation. This eliminates the need for complex cleaning and sterilization validation processes while ensuring sterility, as these simple flexible components are cheaper to dispose of than to reprocess.
2Measurement precision
If sensors and control valves are used for metered filling, then filling precision is improved, but contamination risk and device complexity increase
Solution Approach 1:
Sensors and control valves are extracted from the sterile interior and placed exclusively in the non-sterile exterior region. The sterile flexible components contain only the media to be filled, while all measurement and control elements operate outside the sterile boundary, eliminating contamination risk while preserving filling precision through external monitoring of the flexible components' state.
3Ease of manufacture
If reusable filling devices are used, then equipment cost is reduced, but cleaning and sterilization effort increase
Solution Approach 1:
The flexible components (bags and hoses) are designed for single-use and discarded after one filling operation, eliminating the time-consuming cleaning and sterilization cycles. Reusable fixed elements are recovered and used for multiple operations. This hybrid approach reduces overall time investment compared to reprocessing entire systems while maintaining cost-effectiveness through selective disposal of simple components.
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
Enables sterile, precise, and cost-effective metered filling of media in a non-sterile environment with minimized equipment and personnel costs, reducing the risk of contamination and eliminating the need for complex validation processes.
Implementation Method 1
wherein the device is designed to deliver a predetermined volume of the media to be filled, which corresponds to the space between the lower opening of the at least one measuring container and the closable outlet
Data Source
Figure 1a~1d
Figure 2~2c
Figure 3~3b
AI summary
The invention relates to a device (1) for metering media (2) and comprises at least one storage vessel (3), a measuring vessel (14) and a target vessel (14) that are interconnected to give one unit. By the exertion of force on the media (2) to be metered they can communicate between the storage vessel (3) and the measuring vessel (4) and can then be transferred to the target vessel (14). The metering volume is determined by the geometry of the measuring vessel (4). The target vessel (14) can be separated from the measuring vessel (4) by severing (welding, gluing, cutting) the connection between (14) and (4). The invention also relates to a method for metering media using the device (1) according to the invention. The device is suitable as a disposable unit and for the sterile metering of media in a non-sterile environment.