Embedded Filtration Device for Sterile Fluid Bag
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Solution Overview
Problem
Conventional methods for manufacturing sterile solution bags require expensive equipment, stringent protocols, and centralized production, leading to high costs and risks of contamination, especially when transporting these bags over long distances.
Innovation Solution
A product bag with an integrated filtration system that includes a bladder with sealed film layers and an embedded elongated filtration device, allowing for microbial and particulate filtration during filling, enabling sterile fluid introduction in non-traditional settings and facilitating compact configuration for conventional manufacturing and shipping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If terminal sterilization is used, then sterility is achieved, but capital expenditure and space requirements increase
Solution Approach 1:
The filtration device is integrated into the bag before filling, allowing sterilization to occur during the filling process itself rather than requiring separate terminal sterilization equipment. The filter is pre-positioned within the bag structure, enabling contaminants to be removed as fluid is introduced.
Solution Approach 2:
The filtration device is merged with the bag structure by embedding it within the perimeter seal between film layers. This integration combines the bag and filter into a single unit, eliminating the need for separate sterilization equipment and reducing capital expenditure requirements.
2Reliability
If terminal sterilization is used, then sterility is achieved, but production costs increase
Solution Approach 1:
The filtration function is built into the bag before filling operations, allowing sterilization to occur during the filling process itself. This eliminates the need for separate terminal sterilization steps and reduces overall production costs.
Solution Approach 2:
The bag with integrated filter performs its own sterilization function during filling, without requiring external autoclave equipment. The system serves its own sterilization needs, reducing dependency on expensive centralized sterilization facilities.
3Reliability
If aseptic filling is used, then contamination is prevented, but equipment and procedural complexity increase
Solution Approach 1:
The filtration device is pre-integrated into the bag structure before filling, allowing the filling process itself to serve as the sterilization step. This eliminates the need for separate aseptic filling equipment and reduces procedural complexity.
Solution Approach 2:
The filtration device is merged with the bag structure by embedding it within the perimeter seal between film layers. This integration combines the bag and filter into a single unit, simplifying both equipment requirements and filling procedures.
4Productivity
If centralized production is used, then manufacturing efficiency is improved, but transportation costs and time increase
Solution Approach 1:
The bag with integrated filter performs its own sterilization function during filling, eliminating the need for centralized autoclave facilities. This enables decentralized production at local sites, reducing transportation distances and time while maintaining manufacturing efficiency.
Solution Approach 2:
The filtration function is built into the bag before filling operations, allowing sterilization to occur during the filling process itself. This enables local production and immediate use, eliminating the need for long-distance transportation of sterilized products.
5Reliability
If terminal sterilization is used, then sterility is achieved, but solution formulation stability may be degraded
Solution Approach 1:
The filtration device is integrated into the bag before filling, allowing sterilization to occur during the filling process itself. This preliminary sterilization action prevents contamination without requiring subsequent terminal sterilization that could degrade the solution formulation.
Solution Approach 2:
The filtration device rapidly removes contaminants during the filling process, achieving sterilization in the same time frame as filling. This eliminates the need for separate terminal sterilization steps that could expose the solution to prolonged heat and degrade its formulation stability.
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
This solution reduces production costs, allows for sterile fluid introduction in non-traditional environments, and ensures the sterility of pharmaceutical fluids, thereby minimizing contamination risks and transportation costs.
Implementation Method 1
an elongated filtration device having a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm
Data Source
Figure 1
Figure 2A~2C
Figure 3
AI summary
A product bag includes a bladder and an elongated filtration device. The bladder includes opposing first and second film layers defining a product chamber. The first and second film layers are sealed together along a perimeter seal extending along at least a portion of a perimeter of the bladder. The elongated filtration device includes a housing, a filtration membrane disposed in the housing, an inlet adapted for receiving a fluid to be filtered, and an outlet in fluid communication with the product chamber. A majority of the elongated filtration device is embedded between the first and second film layers of the perimeter seal of the bladder to provide for a compact form factor.