Accelerated stability tests estimate the shelf life of perishable products under normal conditions by subjecting them to stress conditions. This eliminates the need for long-term storage and allows for appropriate expiration dates. Controlled conditions are critical, but physical and chemical changes may occur that would not under normal conditions. Regulatory agencies have guidelines for expedited stability testing to ensure safety.
Accelerated stability tests subject a perishable product to stress conditions to estimate shelf life under ordinary circumstances. In these tests, companies encourage the product to fail in a short period of time in harsh environments and use this to estimate what might happen under normal conditions. This eliminates the need to keep products in storage for months or years for stability testing, waiting for them to fail, an approach that would be impractical. Once companies determine a reasonable range of stability, they can label future runs of that product with appropriate expiration dates.
Product storage recommendations can specify temperature, humidity, and pH. In stability testing, companies must keep a sample of the product in the right condition and monitor it to determine when it fails. Technicians can also run a second accelerated test to estimate when the product will fail and prepare a reasonable shelf life extrapolation so that the product can go on sale. Accelerated testing accelerates the degradation process with heat, improper humidity, and unbalanced pH.
Controlled conditions are critical to accelerated stability testing. Technicians closely monitor all environmental factors as they test the product and repeat the test until it starts to fail. This can be used to evaluate pharmaceuticals and foods, both of which have perishability issues. In the case of medicines, out-of-date medicines may not be effective and could make people ill, while stale food could undergo chemical changes or be colonized by organisms that could spoil it and cause disease.
Material testing companies can rate products for shelf life, and companies can also run their own tests. Regulatory agencies typically have guidelines for expedited stability testing to make sure they are standardized and safe. Inspectors may request copies of test reports in connection with applications for the sale and labeling of products. They can review the documentation to confirm that the tests were conducted appropriately and can request a retest if in doubt.
One concern with these tests is that important physical and chemical changes can occur during accelerated stability tests that would not occur under normal conditions. For example, if eggs are subjected to high heat, the proteins denature and the eggs enter a cooked state. No matter how long the eggs sit in the refrigerator under the recommended storage conditions, they won’t cook. Therefore, the degree of utility of the test is a matter of debate, because it can be difficult to accurately map the results of accelerated stability tests to normal storage conditions.
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