Sensor Fitting for Biotech Process Bag Sterilization
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
In biopharmaceutical processes, existing conductivity and temperature measurement methods are not optimal for lightweight, collapsible process bags due to bulkiness of in-line devices and incompatibility with sterilization processes, and require a contamination-free, easy-to-use, and universally adaptable solution for measuring fluid properties within process bags.
Innovation Solution
A conductivity sensor with probes and a temperature sensor integrated into a sensor fitting that uses an O-ring seal and a heat-sealed skirt portion to attach to a port plate on the process bag, compatible with gamma or ethylene oxide sterilization, and designed for easy removal and universal adaptability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If an in-line gauge is used to measure conductivity in a fluid stream, then measurement capability is provided, but the device becomes bulky and intrusive, which is not optimal for lightweight flexible tubing
Solution Approach 1:
The sensor system is divided into separate components: a port plate integrated into the bag, a sensor fitting that attaches to the port plate, and the sensor element itself. This segmentation allows the measurement function to be provided while keeping each component compact and suitable for lightweight flexible tubing applications.
Solution Approach 2:
A port plate with receptacle serves as an intermediary structure between the bag and the sensor. This intermediary allows the sensor to be attached externally to the bag without requiring the sensor itself to be bulky or intrusive within the flexible tubing.
2Measurement precision
If a traditional gauge is inserted into a vessel port to measure conductivity and temperature, then measurement capability is provided, but the insertion is not optimal for lightweight collapsible thin-walled vessels
Solution Approach 1:
The port plate is pre-integrated into the bag during bag manufacturing, with receptacles prepared in advance. This preliminary action eliminates the need to manually create openings or perform complex insertion procedures into thin-walled vessels, making the process simpler and more suitable for lightweight collapsible bags.
Solution Approach 2:
The port plate serves multiple functions: it provides structural support, creates sealed openings, and houses receptacles for multiple sensors. This multi-functionality makes it ideal for lightweight collapsible vessels where every component must serve multiple purposes to reduce overall complexity.
3Ease of manufacture
If adhesives or glues are used to attach sensors to process bags, then attachment is achieved, but contamination risk increases and adhesives may not work in contamination-free environments
Solution Approach 1:
The chemical attachment method (adhesives/glues) is replaced with a mechanical attachment system using a port plate with receptacles and a sensor fitting with complementary geometry. This mechanical system provides secure attachment without introducing adhesives that could contaminate the sterile environment.
Solution Approach 2:
The port plate and sensor fitting are designed as single-use disposable components that are sterilized and attached mechanically. This approach eliminates the need for reusable adhesives that would require cleaning and sterilization, reducing contamination risk while maintaining ease of manufacture.
4Reliability
If heat sterilization is used for process bags, then sterilization is achieved, but sensors made of incompatible materials cannot be sterilized, and gamma or ETO processing is required instead
Solution Approach 1:
The system is segmented into a sterilizable port plate integrated into the bag and a separate sensor fitting that can be sterilized independently. This segmentation allows each component to be sterilized by methods compatible with its specific materials, with gamma or ETO processing being applied to both components separately.
5Ease of operation
If a sensor is designed for simple and easy removable connection with a biotech process bag, then ease of use is improved, but universal adaptability to numerous applications may be compromised
Solution Approach 1:
The sensor fitting is designed with a universal interface that can attach to port plates with standard receptacles. The complementary geometric features (protrusions fitting into recesses) provide easy removable connection while the standardized design allows universal adaptability across numerous biotech process bag applications.
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 accurate, contamination-free measurement of fluid conductivity and temperature within process bags, ensuring compatibility with sterilization processes and ease of use across various applications.
Implementation Method 1
An O-ring seal is provided between the sensor fitting and the port plate
Implementation Method 2
The skirt portion is heat sealed to the process bag
Data Source
Figure 1~2
Figure 3
Figure 4
AI summary
A fluid process application bag includes a flexible film body having an opening, a port plate sealed around the opening of the flexible film body, a sensor fitting and a sensor contained within the sensor fitting. The port plate has a receptacle defining a passage in fluid communication with an interior of the flexible film body and the sensor fitting has a body portion seated within the passage of the receptacle and is coupled to the receptacle. The sensor has at least one probe communicating with the interior of the flexible film body.