Closed-Manifold Aseptic Bag Filling for Precise Small-Bag Dosing
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Solution Overview
Problem
Existing aseptic bag filling systems require dedicated cleanrooms or isolator systems, are costly, complex, and prone to breaches, making them unsuitable for small bags and lacking precise fluid measurement capabilities.
Innovation Solution
An aseptic bag filling system that operates outside a Grade A cleanroom, using a closed fluid manifold with a bag feeder and sealing system to fill bags individually, ensuring sterility without exposing components to the environment, and incorporating a processor system for precise fluid control and measurement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a dedicated cleanroom or isolator system is used for aseptic filling, then sterility is maintained, but device complexity and cost increase significantly
Solution Approach 1:
The patent extracts the sterile environment requirement from the filling system by using pre-sterilized bags that are sealed in a sterile state and then transferred to the filling machine. This separates the sterilization function (performed on bags before filling) from the filling operation, eliminating the need for a dedicated cleanroom or isolator system while maintaining sterility throughout the process.
Solution Approach 2:
The bags are sterilized and sealed in advance before being loaded into the filling machine. This preliminary sterilization action allows the filling process to occur in a non-sterile environment while the bags themselves remain sterile, thereby reducing system complexity while maintaining product sterility.
2Productivity
If parallel filling of multiple bags is performed, then productivity increases, but measurement precision of individual bag fluid volume decreases
Solution Approach 1:
The patent segments the filling process into individual bag operations rather than concurrent parallel filling. The fluid manifold sequentially connects to and fills one bag at a time, allowing precise weight measurement for each individual bag while maintaining efficient production throughput through automated sequential processing.
3Extent of automation
If automated filling is implemented, then operator intervention is reduced, but difficulty of detecting and measuring individual bag weight increases
Solution Approach 1:
The patent combines the fluid filling pathway with the weight measurement function by integrating a scale into the fluid manifold assembly. As each bag is connected to the manifold for filling, the scale simultaneously measures the bag's weight, enabling automated precise measurement without adding operational complexity.
4Reliability
If isolator and barrier systems are used, then sterility is ensured, but loss of time for regular sterilization and maintenance increases
Solution Approach 1:
The patent extracts the sterilization requirement from the filling environment and applies it only to the bags themselves through pre-sterilization. This eliminates the need for continuous sterilization of a large isolator system, reducing maintenance time and operational disruptions while maintaining sterility of the product.
Data Source
AI summary
Embodiments are directed toward an aseptic bag filling system. In some embodiments, the aseptic bag filling system selectively and aseptically fills sterilized bags with a fluid. The bags are dispensed from a magazine that stores the bags while the bags are fluidly coupled to a fluid manifold via respective fluid pathways. The bags define a closed system, the interior of which, after sterilization, is not exposed to the external environment through filling of the bags with the fluid, sealing such filled bags, and separating or cutting such sealed bags from the manifold.