Membrane Degassing in Drug Product Filling for Weight Accuracy
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Solution Overview
Problem
Existing drug product filling devices face challenges in achieving accurate filling weights due to gas reintroduction during the filling process, incomplete degassing, and inefficiency, leading to potential user safety risks and time-consuming separate degassing steps.
Innovation Solution
A drug product filling device with an integrated degassing system using a membrane-based degasser, such as a hollow fiber membrane module, to partially separate gases from the liquid drug product before filling, ensuring continuous and efficient gas removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a vacuum degassing step is applied to remove gases from the bulk solution, then gas content is reduced, but the process becomes time-consuming and separate from the filling operation
Solution Approach 1:
The patent combines the degassing function with the filling operation by integrating a degassing device into the filling line. The degassing device is positioned between the bulk solution storage and the filling station, allowing gases to be removed from the solution continuously as it flows through the system, rather than requiring a separate batch degassing step. This merging of functions eliminates the time loss associated with separate degassing operations while maintaining effective gas removal.
Solution Approach 2:
The patent implements continuous degassing action by flowing the bulk solution through a membrane-based degassing device that operates continuously during the filling process. The membrane separator allows gases to be continuously stripped from the solution as it passes through, ensuring that the solution remains degassed throughout the filling operation without requiring intermittent batch processing. This continuous action eliminates downtime and maintains productive flow.
2Ease of operation
If gaseous nitrogen is used to transfer the bulk solution to the filling device, then solution transfer is achieved, but gas content increases and filling weight accuracy decreases
Solution Approach 1:
The patent introduces a membrane-based degassing device as an intermediary between the bulk solution storage and the filling station. This intermediary device removes dissolved gases from the solution through the membrane separator, preventing gas contamination that would otherwise occur during transfer. By placing this gas-removal intermediary in the flow path, the system achieves both smooth solution transfer and maintained filling weight accuracy without relying on gaseous nitrogen for transfer.
3Reliability
If stationary degassing of the bulk solution is performed, then gas removal is achieved, but complete removal of dissolved gases is not accomplished
Solution Approach 1:
The patent replaces traditional mechanical vacuum degassing methods with a membrane-based separation system. The membrane separator operates on a different principle, allowing gases to pass through the membrane while retaining the liquid solution, thereby achieving more complete gas removal. This substitution of the degassing mechanism enables more effective dissolved gas removal compared to conventional stationary vacuum methods.
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 device enhances filling accuracy by reducing gas content, improving weight precision, and maintaining stability of oxygen-sensitive ingredients while minimizing polysorbate aggregate formation, thus increasing yield and safety.
Implementation Method 1
the degassing device comprising at least one membrane for at least partially separating off at least one gas from the liquid drug product
Data Source
AI summary
An inventive drug product filling device for filling a liquid drug product into containers is disclosed. The drug filling device includes a drug product preparer configured for preparing the liquid drug product and a filling station configured for filling the liquid drug product into the containers. The filling station is fluidly coupled to the drug product preparer. A degasser is fluidly interposed between the drug product preparer and the filling station. The degasser has a membrane configured for at least partially separating off gas from the liquid drug product. Methods of (i) filling a liquid drug product into containers, (ii) increasing the accuracy of the filling weight of a liquid drug product in a container, (iii) increasing the stability oxygen-sensitive active pharmaceutical ingredient in a liquid drug product, and (iv) reducing polysorbate aggregate formation in a liquid drug product are also disclosed.