Membrane Chromatography Module Array for Low-Contamination Filtration
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Solution Overview
Problem
Existing filtration and chromatography devices for large-scale pharmaceutical processes are complex, costly, and prone to contamination due to the need for extensive assembly and manual intervention, lacking flexibility and safety in handling large media volumes.
Innovation Solution
A disposable device with preconfigured membrane chromatography modules in a predetermined grid, featuring a rigid piping system, automated valves, and sensors, allowing for flexible operation modes and reduced assembly time, minimizing contamination risks and material costs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If manual assembly and extensive intervention are used in filtration and chromatography devices, then customization and adaptability are improved, but device complexity and contamination risk increase
Solution Approach 1:
The device is pre-assembled in a controlled manufacturing environment with all connections, valves, and membrane modules pre-positioned and pre-sterilized. This preliminary assembly eliminates the need for complex on-site assembly operations while maintaining full customization capability through pre-configured module arrangements.
Solution Approach 2:
The entire filtration and chromatography device is designed as a disposable single-use system. Instead of assembling complex reusable devices, a pre-manufactured disposable device is deployed, used once, and then discarded, eliminating assembly complexity and contamination risks associated with repeated assembly and cleaning of reusable components.
2Ease of manufacture
If reusable filtration devices are used, then investment costs are reduced, but cleaning, validation, and inspection costs increase
Solution Approach 1:
The invention employs disposable single-use filtration and chromatography devices that eliminate the need for expensive reusable equipment infrastructure. While individual disposable devices have lower upfront cost than reusable systems, they eliminate all associated cleaning, validation, and inspection activities, making them economically viable for medium to large volume operations.
Solution Approach 2:
Instead of investing in reusable devices that require extensive cleaning and validation cycles, the system uses disposable devices that are discarded after single use. This approach recovers time and resources by eliminating post-use processing entirely, converting what would be recurring cleaning/validation costs into simple disposal operations.
3Stability of the object's composition
If rigid piping systems are used to connect membrane modules, then flow uniformity and pressure resistance are improved, but dead volume and remixing increase
Solution Approach 1:
The invention uses flexible tubing with optimized dimensions to connect membrane modules instead of rigid piping. The flexible nature of the tubing allows for minimized path lengths and optimized routing that reduces dead volume, while the tubing dimensions are carefully selected to maintain adequate flow velocity and pressure resistance, balancing flow uniformity with minimal substance loss.
4Reliability
If pre-sterilized disposable devices are used, then contamination risk is reduced, but device costs increase
Solution Approach 1:
The devices are pre-sterilized in controlled manufacturing environments using validated sterilization processes. This preliminary sterilization ensures high reliability and contamination resistance upon delivery, while the costs are distributed across mass production, making individual device costs manageable compared to the value of contamination prevention in pharmaceutical manufacturing.
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
Enables efficient, safe, and cost-effective separation or purification of large volumes with minimal dead volume and remixing, ensuring uniform flow and reduced risk of contamination through automated control and pre-sterilization.
Implementation Method 1
a plurality of membrane chromatography modules 12 fixed in a predetermined grid arrangement
Implementation Method 2
membrane chromatography modules 12 for the separation or purification of a large volume of a mixture of substances
Data Source
Figure 1
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AI summary
The invention relates to a single-use device (10) for the separation or filtering of a large volume of a mixture of substances, comprising a plurality of membrane chromatography modules (12), which are securely attached in a predefined grid formation. The single-use device (10) also comprises a piping system for linking the membrane chromatography modules (12) and for connecting the membrane chromatography modules (12) to one another. The membrane chromatography modules (12), in particular in terms of the membrane adsorber type, construction type and/or construction size, and/or the lines of the piping system are/can be pre-configured for a desired process. A cover unit (56) and/or a base unit (58) can be attached to the upper side and/or underside of a plurality of membrane chromatography modules (12), which holds the membrane chromatography modules (12) in position in a predefined grid formation. At least one part of the piping system of the single-use device (10) is formed in the cover unit (56) and/or in the base unit (58), with connecting lines between the membrane chromatography modules (12). In a method for separating or filtering a large volume of a mixture of substances using a single-use device (10) of this type with multiple automated valves (44) and sensors (48, 50, 52, 56), which are connected to a control unit, the automated valves (44) are controlled based on an evaluation of the parameters measured by the sensors (48, 50, 52, 56).