Shelf Life and Accelerated Aging Testing

Accelerated aging (AA) on materials, products and packaging systems, including packaged medical devices, to provide a lens into real-time shelf life. Service providers may offer both accelerated aging and real-time (RT) aging for your pharmaceutical, biotech, medical device and consumer product packaging. AA conditioning, based on the Q10 theory of ASTM F1980, allows you to evaluate your package system performance. Series of qualified test chambers help in evaluating and defining shelf life claims in a fraction of the time. RT aging programs and storage at typical conditions are also offered by analytical testing laboratories. Sub-Zero environmental chambers accommodate a complete suite of storage capabilities and testing programs: -30°C to +60°C walk-in environmental chamber for sterile barrier systems +23°C ± 1°C /50% RH ± 2% walk-in environmental chamber for real-time/controlled environment Reach-in and bench-top chambers with capabilities from -20°C to +170°C for developmental studies +5°C ± 3°C ICH refrigerated long-term storage +25°C ± 2°C /60% RH ± 5% ICH long-term/accelerated (refrigerated) +30°C ± 2°C /65% RH ± 5% ICH intermediate (Zones I, II, III and IVa) +30°C ± 2°C /75% RH ± 5% ICH long-term (Zone IVb) +40°C ± 2°C /75% RH ± 5% ICH accelerated (Zones I–IV) -20°C ± 5°C ICH long-term (frozen) -70°C through -90°C cryogenic storage Due to the integration of active pharmaceutical ingredients (API) and antimicrobial agents, more medical devices are being considered combination products than ever before. While the stability of these ingredients is often known, it must be tested in conjunction with the device. ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) provides guidelines in a joint effort of regulators and researchers from Japan, Europe, and the U.S. to help ensure the safety of these combination products and outline the testing requirements. These testing requirements include specific temperature, humidity, and duration specifications, as well as tolerances of the chambers used for the storage conditions. After subjecting the combination product to the condition, certain stability-indicating tests need to be performed to assure potency, functionality and sterility for the intended shelf-life of the medical device product. Long-term or short-term (accelerated) shelf life testing services give access to analytical, microbiological, and toxicological labs throughout entire medical device design process. Accelerated aging studies are designed to increase the rate of chemical degradation or physical change of a substance or product by using exaggerated storage conditions as part of the formal stability study. Data from these studies, in addition to long-term stability studies, can be used to assess longer-term chemical effects of non-accelerated conditions and to evaluate the effect of short-term excursions outside the label storage conditions. Intermediate accelerated aging studies conducted at 30°C and 65% relative humidity (RH) are designed to moderately increase the rate of chemical degradation or physical changes for a substance or product intended to be stored long term at 25°C. Long-term studies designed to represent real-time use as required by the FDA are also available under the recommended storage conditions for the shelf life proposed (or approved) in the label claim. Stability conditions available for use: 25°C ± 2°C / 60% RH ± 5% RH, 30°C ± 2°C / 65% RH ± 5% RH, 40°C ± 2°C / 75% RH ± 5% RH, 5°C ± 3°C, –20°C ± 5°C