Gibraltar Laboratories is a respected testing laboratory providing stability testing. Our stability tests are ICH compliant, adhering to the guidelines and best practices recommended by the International Conference on Harmonization (ICH).
What is ICH stability testing? By performing the ICH stability test, a drug, device, biotech manufacturer obtains rapid assurance that the given product will be safe and effective for the entire duration of the product’s stated shelf life. This is a critical regulatory requirement. Gibraltar Laboratories conducts ICH stability testing at room temperature to effectively reproduce real-life storage conditions. To simulate longer spans of storage, we are also capable of conducting “accelerated” stability testing which is done at temperatures up to 55 °C.
Gibraltar Laboratories uses advanced digital systems to monitor our test chambers 24 hours a day, helping ensure that temperature and humidity conditions are under control. We store samples under exactly defined conditions that are continuously documented. Three lots are placed in the chamber and the stability indicating tests chosen by the sponsor are performed. For example, potency, sterility, package integrity are assessed. Using 40C as the acceleration temperature [and the Arrhenius equation] one can forecast that in only three months the expected outcome of one year’s storage at 20C. As the temperature is further increased, for example to 55C for package integrity assessment , only one month is required to forecast the expected outcome of the test attribute after one year’s storage at 20C.
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