An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system.
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Determination of composition or purity of your materials, controlling quality, and identifying unknown substances.
Determine the toxicity to cells of compounds either qualitatively or quantitatively.
Toxicology studies are used to characterize the toxicity profile of a drug by identifying its impact on organ structure and / or functionality. This includes assessment of the severity and reversibility of toxicity, as well as dose ranges and their relationship to exposure.
Complement activation is a component of the innate immune system that helps eliminate microorganisms and damaged cells by attacking the cell's plasma membrane. Activation of the complement system by a medical device or other foreign material can have deleterious effects including tissue damage and inflammation. ISO 10993-4 recommends that some medial devices be tested for complement activation.
Heavy Metal Elemental Analysis
For pharmaceutical products, the quantification of the load of heavy metals is done to identify contaminants and to perform bioanalysis on therapeutics designed to contain heavy metals.
Trace Elemental Analysis
Measure inorganic impurities in pharmaceutical, biological, and nutraceutical formulations.
Medical Device Shelf Life Testing
Medical device manufacturers wishing to gather data on the shelf life of their products may subject their devices to long-term stability studies or accelerated ageing studies. Many different endpoints can be used to assess the shelf life of a medical device, including sterility or package integrity, so it is important that endpoints and test methodology are decided upon before testing is begun.
Small Molecule Identification and Purity Testing
Identity and purity testing are crucial requirements of a lot-release. There are a variety of testing methods to determine drug substances and products to ensure that final drug products match client specifications. Infrared spectroscopy is notably the most powerful test in confirming the identity of small molecules and pharmaceuticals. As written in USP <197>, “the IR absorption spectrum of a substance […] provides perhaps the most conclusive evidence of the identity of the substance that can be realised from any single test.” FTIR results may be used to compare multiple specific peaks in the IR spectrum with those of a reference standard, establishing robust acceptance criteria.
Extractable's & Leachable's
Leachable impurities can migrate from components in container closure systems, packaging systems, storage systems, process equipment, and device packaging, which affect the overall purity and safety of the therapeutic product. In order to identify potential sources of leachables, it is important to conduct controlled extraction studies to identify extractables and the components that generate them. Hence testing for Extractables and Leachables (E&L) is crucial to product release.