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 systems are used for fluid transfer in pharmaceutical manufacturing, then fluid transfer can be achieved, but the systems are cumbersome and prone to cross-contamination
Solution Approach 1:
The system divides the fluid transfer process into separate sterile and non-sterile zones using the fluid plug as a barrier. The plug segments the conduit into isolated sections, allowing sterile fluid to be handled without exposing the entire system to contamination risk, thereby simplifying the overall system design while maintaining reliability.
Solution Approach 2:
The fluid plug acts as an intermediary element that interfaces between sterile and non-sterile environments. It allows controlled interaction between these zones without direct exposure, enabling safe fluid transfer while maintaining sterile integrity and reducing system complexity.
2Reliability
If repeated cleaning and sterilization activities are performed on components, then cross-contamination is avoided, but the process becomes time-consuming and inefficient
Solution Approach 1:
The fluid plug is designed as a disposable component that maintains sterility throughout its service life and is then discarded rather than cleaned and sterilized repeatedly. This eliminates time-consuming sterilization cycles while ensuring sterility is maintained, directly improving manufacturing efficiency without compromising reliability.
Solution Approach 2:
The system performs preliminary sterilization of the fluid plug before use and maintains its sterile state throughout the process. By preparing the sterile barrier in advance and maintaining it without repeated cleaning cycles, the system improves productivity while ensuring sterility is preserved.
3Reliability
If gamma irradiation is used for sterilization, then effective sterilization is achieved, but existing plugs may be damaged
Solution Approach 1:
The plug is made from materials with modified physical and chemical parameters that are specifically selected to withstand gamma irradiation. The material composition and structural parameters are changed to be radiation-resistant, allowing effective sterilization without compromising plug integrity or causing damage.
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 fluid plug ensures sterile integrity and safe sterilization of systems by forming a damage-free seal and allowing for aseptic fluid transfer, reducing the risk of contamination and maintaining system sterility during gamma irradiation.
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.