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Shelf Life & Accelerated Aging Testing

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

AMRI performs accelerated aging (AA) on materials, products and packaging systems, including packaged medical devices, to provide a lens into real-time shelf life.

Forced Degradation Studies

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

Forced Degradation Studies

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

Forced Degradation Study

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

Accelerated Stability

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

Room Temperature & Accelerated Chambers

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

Forced Degradation Studies

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

Degradation Studies For The Development

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Neopharm has two distinct validation departments; chemistry and microbiology. Each validation department is dedicated to development, validation, verification, recovery and inter-laboratory transfer of analytical methods.

Packaging Stability Studies

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.

40°C/75% RH (Accelerated stability)

Analytical >> Packaging and Distribution Testing >> Shelf Life and Accelerated Aging Testing

Neopharm offers a full range of stability testing and storage services to meet the performance needs of our clients. Our stability operations include 15,000 cubic feet of walk-in/reach-in chambers/incubators that meet the ICH guidelines requirements.

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

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