Ensuring that medical devices and biotechnological products remain safe, functional, and sterile throughout their shelf life is of critical importance for patient safety. Since real-time tests take a long time, accelerated aging tests, which achieve the same effect in a shorter period, are preferred. In these tests, products are kept under controlled specific temperature and humidity conditions, accelerating the effects of time in a laboratory environment.
IVBIO conducts these studies in accordance with the ASTM F1980 Standard. The test duration is calculated based on the product's storage conditions, targeted shelf life, and temperature parameters. All operations are carried out in calibrated stability cabinets where temperature and humidity are continuously monitored. Thus, the accuracy of environmental conditions and the reproducibility of results are guaranteed.
At the end of the aging process, the product's sterility, package integrity, and functional performance are tested. Studies are repeated when there are changes in production, packaging, or sterilization methods.
IVBIO offers manufacturers both reliable results and regulatory consultancy through scientifically based tests compliant with international standards.
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The ability of medical device packaging to maintain sterile barrier integrity depends on the durability of the seal areas. Seal strength tests evaluate the reliability of these areas in terms of leak-tightness, opening behavior, and deformation risks.
IVBIO performs these tests in full compliance with ASTM F88/F88M and EN 868-5 standards, as well as TS EN ISO 11607-1 requirements. All processes are conducted with validated methods and calibrated equipment, integrated with quality management systems.
In the tests, packaging samples are pulled at specific speed and force parameters to measure the seal strength in Newtons. Results are analyzed using criteria such as average force value, peel behavior, and continuity of the seal line. Deformations are also evaluated through visual inspections.
IVBIO offers not only numerical data but also comprehensive technical analysis regarding packaging performance. It provides consultancy services on design, material selection, and production parameters when necessary.
Test results compliant with international standards document the reliability of medical devices within the scope of global regulations.
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The leak test is the most critical quality control stage evaluating whether medical device packaging maintains its integrity as sterile barrier systems. This test determines if there is any leakage or loss of integrity in the package's seal lines, guaranteeing that product sterility is maintained throughout the shelf life.
IVBIO performs leak tests in accordance with the ASTM F1929 standard, using validated methods. All processes are conducted in a traceable and reproducible manner within the scope of the quality management system.
During the test, a dye solution is applied to the package's seal lines, and potential leaks are observed. This method (dye penetration) offers high-precision results by enabling the detection of even microscopic leaks. Packages where dye passage is detected are evaluated as non-compliant in terms of leak-tightness.
Acting with the principles of compliance with international standards, accuracy, and reliability in all tests, IVBIO produces reliable test reports accepted in medical device regulations.
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