Gamma-Sterilizable Fluid Plug for Aseptic Conduit Sealing
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Solution Overview
Problem
In pharmaceutical and biologic manufacturing processes, there is a need for devices and systems that maintain the sterile integrity of solutions and reagents during handling and sterilization, particularly in environments where gamma irradiation is used, as existing systems are cumbersome and prone to cross-contamination.
Innovation Solution
A fluid plug designed for use with flexible polymer conduits, featuring a cap, shank, flexible ring, and lever that forms a fluidic seal upon actuation, made from materials tolerant of gamma irradiation, allowing for sterile transfer and connection of fluids and reagents in a block-and-bleed arrangement with valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional plugs and sealing mechanisms are used in sterile pharmaceutical and biologic manufacturing processes, then the system complexity and risk of cross-contamination increase, but the need for repeated cleaning and sterilization activities becomes necessary
Solution Approach 1:
The plug is divided into distinct functional segments: a body portion for insertion, a flexible ring for sealing, and a lever for actuation. This segmentation allows each component to perform its specific function efficiently while maintaining overall system simplicity and sterility.
Solution Approach 2:
The plug design extracts the essential sealing function from complex valve mechanisms by using a simple lever-actuated flexible ring system that can be independently inserted and removed from conduits, eliminating the need for complex integrated sealing systems.
2Adaptability or versatility
If multiple conduits and valves are used for transporting reactants and solutions in batch processes, then the ability to handle multiple processes is improved, but the frequency of cleaning and sterilization activities increases
Solution Approach 1:
The plug is designed as a disposable component that can be inserted into conduits for single-use sterile processes and then removed and discarded, eliminating the need for time-consuming cleaning and sterilization cycles while maintaining the ability to handle multiple processes.
Solution Approach 2:
The plug maintains sterile barriers in place before processes begin, allowing batch processes to be prepared and staged without immediate sterilization needs, and enables rapid transition between processes by simply replacing plugs rather than sterilizing entire systems.
3Reliability
If sterile barriers are maintained throughout the process using conventional methods, then the sterility of solutions and reagents is preserved, but the complexity of integration with larger production systems increases
Solution Approach 1:
The plug acts as an intermediary sterile barrier that interfaces between the sterile environment and the larger production system, providing a simple connection point that maintains sterility without requiring complex integration mechanisms.
Solution Approach 2:
The plug design provides universal applicability across different conduit sizes and configurations through standardized dimensions and materials, enabling easy integration with various production systems while maintaining sterile barriers through its simple insertion and sealing mechanism.
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 plug ensures damage-free sealing and removal without compromising the sterility of the system, enabling aseptic connections and maintaining the integrity of sterile solutions and reagents throughout the manufacturing process, including gamma irradiation sterilization.
Implementation Method 1
a flexible ring disposed along a portion of the shank, and a lever mounted on the cap and configured to shorten the shank upon actuation, wherein actuation of the lever causes radial expansion of the flexible ring and forms a fluidic seal with an interior surface of the flexible polymer conduit
Data Source
AI summary
A fluid plug for use with sterile processes such as the manufacture or production of pharmaceuticals and biologics is disclosed. The fluid plug is made of a material or materials that will tolerate sterilizing processes such as gamma irradiation. The fluid plug is used to selectively plug the ends of flexible polymer conduits that may be connected to fluids, reagents, or products used or generated as part of the manufacturing process. Also disclosed is the use of the plugs in combination with a series of valves in a block-and-bleed arrangement to enable the sterile transfer and connection of fluids, reagents, or products within a process flow.