Disposable Container Integrity Testing for Sterile Biopharma Shipping
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Solution Overview
Problem
Existing systems for manufacturing biopharmaceuticals using disposable containers face challenges in maintaining sterility during shipment and detecting leaks smaller than 100 μm, which can allow contaminants like bacteria to enter, and there is a lack of comprehensive systems for packaging, shipping, and integrity testing from assembly to client sites.
Innovation Solution
A system for testing the integrity of disposable containers at reduced volume and constant pressure, using a device that constrains the container to maintain surface area for gas flow and collects leaks, combined with methods for vertical and horizontal deployment, foam management, and improved impellers and seals to ensure sterility and efficient filling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If disposable containers are used for biopharmaceutical manufacturing, then ease of manufacture and sterilization are improved, but the ability to detect small leaks (smaller than 100 μm) deteriorates
Solution Approach 1:
The patent introduces an intermediary testing system that uses gas flow through the container walls to detect leaks. The system employs a gas source, flow meter, and pressure monitoring to create a measurable gas flow path through potential leak points, enabling detection of leaks smaller than 100 μm that would otherwise be undetectable by conventional methods
Solution Approach 2:
The patent replaces conventional mechanical leak detection methods (which rely on visual inspection or pressure holding) with a gas flow-based detection system. By introducing gas through the container and measuring the flow rate, the system can detect minute leaks through quantitative flow measurement rather than mechanical pressure changes
2Reliability
If comprehensive packaging and integrity testing systems are implemented, then reliability and sterility are improved, but device complexity increases
Solution Approach 1:
The patent segments the integrity testing process into distinct functional modules: a packaging system for sterile containment, an integrity testing system with gas flow measurement, and a deployment system. This segmentation allows each module to be optimized independently while maintaining overall system reliability and sterility
Solution Approach 2:
The patent designs the packaging and testing system to serve multiple functions: sterile packaging during shipment, integrity testing through gas flow measurement, and controlled deployment at the client site. This multi-functionality reduces the need for separate systems while maintaining sterility and reliability
3Measurement precision
If containers are constrained at reduced volume for testing, then measurement precision is improved, but the container shape changes
Solution Approach 1:
The patent employs a dynamic testing approach where the container is constrained within a housing that allows controlled deformation. The gas flow testing method remains effective despite shape changes because it measures flow through the container walls rather than relying on rigid geometric constraints, adapting to the container's deformed state
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 provides a non-destructive, high-sensitivity integrity test for disposable containers, ensuring sterility and effective gas venting, while allowing for efficient deployment and handling of biopharmaceutical production equipment without damaging the containers.
Implementation Method 1
the filter maintains sterility within, and allows air/gas to enter, the interior volume
Implementation Method 2
pressurized to 5 psi. Hold pressure X time note pressure drop
Data Source
AI summary
This disclosure relates to equipment utilized to manufacture chemical agents, particularly biopharmaceuticals, using Disposable Containers (DCs).