Removable Conduit for Aseptic Transfer Between Containers
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Solution Overview
Problem
Current methods for transferring sterile products between containers are cumbersome, costly, and restrictive, requiring controlled environments and are not suitable for high-flow rate or viscous products, especially in industrial contexts.
Innovation Solution
A device and method for transferring sterile products under aseptic conditions using a removable conduit that can be sterilized in situ, allowing for quick and easy transfer in non-sterile environments, with independently operable valves and a dual-function pipe system for sterilization and transfer, enabling high flow rates and reusability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional isolators with controlled environments are used for sterile transfer, then sterility is maintained, but the process becomes lengthy and costly
Solution Approach 1:
The transfer system is divided into separate sterile and non-sterile zones connected by a sterile barrier. The sterile container remains isolated while the non-sterile container can be handled freely, allowing parallel processing and eliminating the need for sequential sterilization steps.
Solution Approach 2:
A sterile barrier acts as an intermediary between sterile and non-sterile environments, enabling direct transfer without requiring the entire system to be sterilized. This mediator maintains sterility while allowing rapid connection and disconnection.
2Reliability
If traditional isolators with controlled environments are used for sterile transfer, then sterility is maintained, but implementation complexity and cost increase
Solution Approach 1:
The sterile barrier is extracted as a separate, removable component that can be independently sterilized and connected. This eliminates the need for complex integrated isolator systems while maintaining sterility through a simple, focused sterilization approach.
Solution Approach 2:
The sterile barrier is designed as a single-use or easily replaceable component that can be sterilized quickly and discarded if compromised, eliminating the need for expensive, complex sterilization systems and continuous monitoring infrastructure.
3Ease of operation
If aseptic connectors from prior art are used, then single-use simplicity is achieved, but high flow rates and viscous products cannot be transferred
Solution Approach 1:
The sterile barrier system is designed to handle multiple product types including viscous materials and high flow rates, replacing the need for product-specific connectors. The universal design maintains simplicity while expanding capability to industrial-scale transfers.
Solution Approach 2:
The system parameters including flow rate capacity and viscosity handling are changed by designing the sterile barrier with appropriate pore size, material properties, and structural characteristics that accommodate industrial-scale transfers while maintaining operational simplicity.
4Reliability
If continuous microbiological control is implemented, then sterility is ensured, but operational constraints and costs increase
Solution Approach 1:
Sterilization is performed in advance on the sterile barrier and sterile container before use, eliminating the need for continuous microbiological control during operation. This preliminary action allows the system to be used in environmentally flexible conditions without compromising sterility.
Solution Approach 2:
The sterile barrier maintains continuous sterility protection during the entire transfer process without requiring active monitoring or control systems. The useful action of sterility maintenance continues passively through the physical barrier, providing environmental flexibility.
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 solution allows for efficient, cost-effective, and rapid transfer of sterile products in uncontrolled environments, maintaining sterility without the need for continuous microbiological control, and is suitable for various product viscosities and flow rates, reducing implementation constraints and costs.
Implementation Method 1
means for connecting the removable conduit to a sterilization system for its internal volume, operable when the removable conduit provides a leak-proof connection between the free end of the first pipeline and the free end of the second pipeline
Data Source
Figure 1~3
Figure 4~5
AI summary
The invention relates to a device for transferring a sterile product from one container to another under aseptic conditions, the device comprising a first container (10) intended initially to contain the sterile product and equipped with emptying means comprising a first pipe (11) on which two valves (13, 14) which are operable independently of one another are mounted in series, a second container (20) equipped with filling means comprising a second pipe (21) on which two valves (23, 24) which are operable independently of one another are mounted in series, a removable hose (30) for sealed connection of the free end (112) of the first pipe and of the free end (212) of the second pipe, and means of connecting the removable hose to a system for sterilizing the internal volume thereof (301) which are operable when the removal hose is sealingly connecting the free end of the first pipe with the free end of the second pipe.