It is critical that medical fluid bags and valves do not leak. IV bags, blood bags, and drainage collection bags are all examples of medical fluid bags. IV bags contain electrolytes and medications that flow from the bag into the patient's vein via a tube and a needle to provide them with life-sustaining fluids. The Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have established strict guidelines for testing container closure systems in order to ensure the safety of sterile products like IV bags. Testing these bags for leaks is critical because leaks can risk the overall sterility of the container and thus user safety.
IV Bags Testing using VeriPac 455 Series
VeriPac Vacuum Decay technology is regarded as a highly effective method for evaluating the integrity of liquid filled IV bags. This technology is recommended by UPS 1207 and is an FDA (Food and Drug Administration) consensus standard for Container Closure Integrity testing (CCIT) of high-risk package applications with fast, repeatable and reliable test results that provide quantitative and deterministic quality assurance. Being a non-destructive technique, Vacuum Decay offers a greater understanding of the packages and reduces waste. Irrespective of the defect location, this technology system can pick up both large and small defects. Additionally, PTI VeriPac system ensures leak detection and eliminates false positives by providing quantitative test data.
IV bags can be evaluated effectively using VeriPac 455 leak detection system. It is a non-destructive, non-invasive method that requires no sample preparation. Apart from package integrity testing, VeriPac 455 can be used for stability studies, clinical trial studies, quality assurance testing and production statistical process control (SPC).
Technology Overview
Under this method, a test chamber that is specifically designed to hold the package being evaluated is connected to the VeriPac 455 leak tester. The package is placed inside the test chamber to which vacuum is applied. The test chamber is observed for both vacuum level and change during a defined test time using the dual transducer technology. The presence of leaks and defects within the package is identified by monitoring changes in absolute and differential vacuum. VeriPac 455 series is designed for manual or automatic operation, and it is suitable for laboratory offline testing and QA/QC statistical process control.
Benefits of VeriPac 455 Series
- Non-destructive, non-subjective, no sample preparation
- Defect detection down to 0.01 cc/min
- Highest level of sensitivity, repeatability and accuracy
- Results proven superior to dye ingress
- Deterministic, quantitative test method
- Supports sustainable packaging and zero waste initiatives
- ASTM test method and FDA standard
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