Biopharmaceutical Dispensing Manifold with Closed-Loop Containment
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Solution Overview
Problem
The existing methods for dispensing biopharmaceutical materials are prone to contamination due to exposure to open air and manual handling, which poses risks to patient safety during transfer from a bulk reservoir to smaller containers.
Innovation Solution
A system comprising a bulk reservoir, a manifold with interconnected distribution conduits forming a loop or modified square shape, and a filter assembly that prevents contaminants from entering the containers, along with a sampling container for quality assurance, ensures controlled and contamination-free dispensing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual dispensing is performed in an open-air environment with laminar flow hood, then workers can operate with standard protective clothing, but the biopharmaceutical materials are exposed to contamination risks from open air and manual handling
Solution Approach 1:
The patent implements a closed-loop dispensing system where the biopharmaceutical material remains contained within a controlled environment throughout the transfer process. The system uses interconnected conduits forming a closed loop between the bulk reservoir, distribution manifold, and receiving containers, eliminating exposure to open air and maintaining an inert, contamination-free environment during dispensing operations.
Solution Approach 2:
The patent introduces a closed-loop conduit system as an intermediary between the bulk reservoir and receiving containers. This intermediary system includes filters, pumps, and controlled flow paths that mediate the transfer of biopharmaceutical material without direct manual handling, thereby reducing contamination risk while maintaining operational efficiency.
2Object-affected harmful factors
If closed-loop dispensing system is implemented, then contamination risk is minimized, but system complexity increases
Solution Approach 1:
The patent designs the closed-loop system with multi-functional components that perform multiple operations. The distribution manifold serves both as a flow distribution point and as part of the closed-loop containment structure. The filters are integrated into the flow path to simultaneously filter contaminants and maintain system pressure. This multi-functionality reduces the number of separate components needed, thereby managing system complexity.
Solution Approach 2:
The patent divides the closed-loop system into modular segments including the bulk reservoir, distribution manifold, receiving containers, and filter assemblies. Each segment can be independently maintained, cleaned, or replaced without affecting the entire system. The loop itself is segmented into multiple conduits that can be individually monitored and controlled, making the complex system more manageable and easier to maintain.
3Measurement precision
If sampling is performed during dispensing process, then quality assurance is improved, but the sampling process itself may introduce contamination
Solution Approach 1:
The patent incorporates sampling ports and filtration systems that are pre-integrated into the closed-loop dispensing system. Sampling can be performed at predetermined points in the flow path without breaking the closed-loop containment. The system includes pre-installed filters and sampling mechanisms that allow quality assurance activities to be conducted while maintaining the integrity of the closed environment, thus preventing contamination during sampling operations.
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 system minimizes the risk of contamination by maintaining a controlled environment during dispensing, ensuring the integrity and quality of biopharmaceutical materials, thereby enhancing patient safety and process reliability.
Implementation Method 1
a filter assembly that prevents contaminants from entering the containers
Data Source
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AI summary
A pre-sterilized system (5) for dispensing biopharmaceutical materials includes a reservoir (10) for holding biopharmaceutical materials coupled to a filter and distribution manifold (20) connected to a plurality of receiving containers (30). The manifold (20) includes a plurality of container conduits (60) and a plurality of distribution conduits (50). The plurality of container conduits (60) is connected to the plurality of receiving containers (30) and supports the plurality of distribution conduits (50) above the plurality of receiving containers (30) to allow flow of the biopharmaceutical materials from the plurality of distribution conduits (50) by gravity into the plurality of receiving containers (30. The plurality of receiving containers (30) and the manifold (20) are sealed relative to an ambient environment outside the manifold and the plurality of containers to inhibit contamination of the biopharmaceutical materials when the biopharmaceutical materials are inside at least one of the plurality of receiving containers (30 and the manifold (20).