Automated Filter Integrity Test Apparatus for Sterile Systems
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Solution Overview
Problem
Existing methods for conducting integrity tests on filter devices are prone to manual errors, especially under sterile conditions, which can lead to contamination and require manual handling that increases the risk of erroneous operations.
Innovation Solution
A test apparatus and method that automatically perform integrity tests on filter devices using a microprocessor-controlled system with a pressure sensor and flowmeter, which includes a fluid inlet, outlet, and venting port, and features automated wetting, testing, and draining capabilities, reducing the need for manual intervention and ensuring sterile conditions through controlled gas and liquid handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual connections and disconnections are used to fill, pressurise and drain the filter device, then the operator can control the testing process, but the risk of manual errors and contamination increases
Solution Approach 1:
The test apparatus automatically performs filling, pressurisation, testing, and draining operations without requiring manual intervention. The system uses automated valve control and fluid management to conduct the integrity test independently, eliminating operator handling that could cause contamination or errors.
Solution Approach 2:
Manual mechanical operations (hand-connecting tubes, manual valve operation) are replaced by an automated control system that uses electronic signals to control valves and fluid flow. The microprocessor-controlled system substitutes human mechanical actions with automated mechanical and electronic control mechanisms.
2Reliability
If automated testing is implemented, then operator errors are reduced, but the device complexity increases
Solution Approach 1:
The test apparatus is designed as a multi-functional integrated system that can perform multiple operations (filling, pressurisation, testing, draining) using a single automated control unit. This universal approach consolidates what would otherwise require multiple separate manual operations into one cohesive automated device.
Solution Approach 2:
A microprocessor-based control system acts as an intermediary between the operator and the physical testing components. The control system manages the complexity by providing a simplified interface while coordinating multiple valves, fluid flows, and measurement instruments through centralized electronic control.
3Ease of operation
If multiple valves and connectors are used for automated control, then manual handling is reduced, but the potential failure points increase
Solution Approach 1:
Multiple valve control functions are merged into a single automated control system. The microprocessor-controlled apparatus coordinates all valve operations, fluid routing, and measurement functions through one integrated control unit, reducing the operational complexity despite the presence of multiple physical components.
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 solution significantly reduces the likelihood of operator errors by automating the integrity testing process, allowing for unsupervised testing and ensuring the integrity and sterility of filter devices, while providing accurate results and efficient operation.
Implementation Method 1
a filter integrity testing device having a pressure sensor and/or a flowmeter
Implementation Method 2
a filter integrity testing device having a pressure sensor and/or a flowmeter
Implementation Method 3
the inlet connector is fluidly connected via a wetting liquid supply valve to a wetting liquid supply
Implementation Method 4
the inlet connector is fluidly connected via a drainage valve to a first drain
Implementation Method 5
the venting port connector is fluidly connected via a measurement gas valve to the pressure sensor and/or the flowmeter of the filter integrity testing device
Implementation Method 6
the venting port connector is fluidly connected via a venting valve to a venting pipe
Data Source
Figure 1
Figure 2
AI summary
The invention relates to an apparatus for automatically carrying out an integrity test on a filter device having a fluid inlet, a fluid outlet and a venting port comprising: - a filter integrity testing device having a pressure sensor and/or a flowmeter; - an inlet connector fluidly connectable to the fluid inlet, wherein the inlet connector is fluidly connected via a wetting liquid supply valve to a wetting liquid supply, and wherein the inlet connector is fluidly connected via a drainage valve to a first drain; - an outlet connector fluidly connectable to the fluid outlet, wherein the outlet connector is fluidly connected via an outlet valve to the first or a second drain; - a venting port connector fluidly connectable to the venting port, wherein the venting port connector is fluidly connected via a measurement valve to the pressure sensor and/or the flowmeter of the filter integrity testing device, wherein the venting port connector is fluidly connected via a venting valve to a venting pipe, and wherein the venting port connector is fluidly connected via a measurement gas valve to a measurement gas source; wherein the valves are controlled by means of the filter integrity testing device. The apparatus can alternatively be devised as a valve unit connectable to a filter integrity test device to form a test apparatus. A microprocessor controlled method for carrying out an integrity test on a filter device by means of the test apparatus and an according computer program product are also disclosed.