Sterile Transfer Container for Ampoules Using Nested Design
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Solution Overview
Problem
The existing methods for introducing non-sterile vessels containing sensitive substances into a sterile area are complex and prone to contamination, requiring multiple personnel and involving intricate handling processes.
Innovation Solution
A container designed with sterilizable parts surrounded by a removable cover, allowing non-sterile vessels to be introduced into the sterile area without direct contact, using a device for substance removal that prevents contamination, such as a piercing membrane or needle, and featuring a plug or thread connection for easy assembly and disassembly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If non-sterile vessels are transferred to sterile area using traditional methods (syringes and injection cannulas), then the substance can be transferred, but the handling process becomes complex and requires multiple personnel
Solution Approach 1:
The non-sterile vessel is nested within the sterile container, allowing the vessel to be transferred into the sterile area while remaining protected by the sterile container. The container parts surround the vessel, creating a nested structure that eliminates the need for complex transfer procedures with syringes and multiple personnel.
Solution Approach 2:
The sterile container acts as an intermediary between the non-sterile vessel and the sterile area. By placing the non-sterile vessel inside the sterile container and sealing it, the container mediates the transfer process, allowing the substance to be introduced into the sterile area without direct exposure of the vessel to the sterile environment during transfer.
2Ease of operation
If non-sterile vessels are brought into sterile area, then the substance can be accessed, but contamination risk increases
Solution Approach 1:
The non-sterile vessel is nested within the sterile container, maintaining the sterile barrier while allowing substance access. The container parts surround and protect the vessel, enabling substance removal through the container structure without breaking the sterile seal until the moment of extraction.
Solution Approach 2:
The container parts are prepared and sterilized in advance, and the non-sterile vessel is sealed within the sterile container before entering the sterile area. This preliminary sealing action prevents contamination during the transfer and handling process, allowing safe access to the substance later.
3Object-affected harmful factors
If sterilizable container parts are used to surround non-sterile vessels, then contamination is prevented, but the container structure becomes more complex
Solution Approach 1:
The container is divided into multiple separable parts that can be sterilized independently and then assembled around the non-sterile vessel. The container parts can be connected to one another, forming a complete sterile enclosure without requiring a complex pre-assembled structure.
Solution Approach 2:
The sterile container parts are designed to nest around the non-sterile vessel in a simple sequential manner, with each part surrounding the previous assembly. This nested structure allows for simple sterilization and assembly processes while maintaining effective contamination prevention.
4Ease of operation
If removable cover is used to surround container parts, then handling is simplified and direct contact is avoided, but the assembly process becomes more complex
Solution Approach 1:
The removable cover is pre-assembled and sterilized together with the container parts, and the non-sterile vessel is pre-placed within the container. This preliminary preparation allows the complete assembly to be handled as a single sterile unit, simplifying handling while the pre-assembly process manages the complexity of putting multiple parts together.
Solution Approach 2:
The removable cover acts as an intermediary element that simplifies handling by providing a outer surface for grip and manipulation without requiring direct contact with the container parts. The cover mediates between the user and the sterile components, simplifying handling while the standardized interface manages the assembly complexity.
Data Source
Figure 1~2
Figure 3a~3d
Figure 4
AI summary
The invention relates to a container (5) for receiving at least one unsterile vessel (1, 1’) containing a removable substance (2, 2’), in particular an ampoule with a pierceable rubber stopper (3), and for placing the at least one vessel (1, 1’) into a sterile region (I), with at least two interconnectable parts (6, 7) which, in the interconnected state, are designed for receiving the at least one vessel (1, 1’), wherein one container part (7) has at least one device (11, 11’) for removing the particular substance (2, 2’) from the at least one vessel (1, 1’). In order to provide such a container (5) which can be produced cost-effectively and can easily be handled, the container parts (6, 7) are surrounded by a removable covering (10) comprising at least two parts (8, 9).