- Service Details
AMRI employs high-performance Cincinnati Sub-Zero environmental chambers to provide conditioning, accelerated aging and real-time storage programs to pharmaceutical/biotechnology, medical device and consumer product manufacturers.
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Pharma Service: AnalyticalCategory: Packaging and Distribution Testing
One of the first test processes often required prior to conducting physical testing on the package, container, or packaging component being evaluated is Environmental Conditioning; this process brings the item to be tested into equilibrium with specific temperature and humidity conditions prior to testing. Environmental Conditioning is conducted in an environmental chamber designed to maintain tight controls over temperature and humidity. The test levels chosen and the rates of change between these levels are often typical of what might be encountered during an extreme distribution cycle, for example, or storage for an extended period of time. The temperature and moisture content of the packaging material to be tested is critical, as are the environmental conditions during testing. For example, paper based materials are hydroscopic and will change their strength characteristics as they absorb or release moisture. Analytical testing laboratories provide environmental conditioning, cycling and simulation testing through tests like profile cycle test which include thermal performance of packaging, product quality and reliability, product life expectancy, drug stability protocols, forced degradation studies. Thermal cycle testing is important for product and package development in order to ensure that adverse effects from extremes in climatic conditions do not harm the efficacy of drug products; packaging protects products from excursions in temperature and humidity; and packaging itself does not deteriorate under extremes in climatic conditions. For example; chambers are used specifically for cold chain packaging to validate they are performing as intended and designed for shipping drug products. Distribution and package testing include ASTM & ISTA Distribution Testing, Pharmacuetical Package Testing, Consumer Product Testing, Shelf Life & Accelerated Aging Testing, Environmental Conditioning, Packaging Materials Testing, Package Integrity Testing, Package Strength Testing, Package Labeling, Environmental Testing, Forced Degradation Study. Pharmaceutical/Drug Stability/Cold Chain Package testing include PDA TR #53 Stability Testing to Support Distribution of New Drug Products, PDA TR #39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment, ICH Q1C Stability Testing for New Dosage Forms, ISTA Standard 20/7E Testing Standard for Thermal Transport Packaging Used in Parcel Delivery System Shipment, ISTA 7D – Temperature Test for Transport Packaging. Medical Device Package testing include ASTM D 4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing, ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ASTM F 2825 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery, ISO 11607 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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