An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system.
Determination of the composition or purity of your materials, quality control and identification of unknown substances.
Determine the toxicity of compounds on cells in a qualitative or quantitative manner.
Toxicology studies are used to characterise 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.
The complement Activation is a part of the natural 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 material can have deleterious effects, including tissue damage and inflammation. ISO 10993-4 recommends that certain medical devices be tested for activation of the complement system.
Heavy Metal Elemental Analysis
For pharmaceuticals, heavy metal loading quantification is performed to identify contaminants and to perform bioanalysis on therapeutic products designed to contain heavy metals.
Trace Analysis Elemental of Metals
Measuring inorganic impurities in pharmaceutical, biological and nutraceutical products.
Medical Device Shelf Life Testing
Medical device manufacturers wishing to collect shelf life data on their products may subject their devices to long-term stability studies or accelerated ageing studies. Many different criteria can be used to assess the shelf life of a medical device, including sterility or packaging integrity. It is therefore important that the criteria and test methodology are decided before testing begins.
Small Molecule Identification and Purity Testing
Identity and purity testing are crucial requirements for product release. There are a variety of testing methods for determining pharmaceutical substances and products to ensure that the final pharmaceutical products meet the customer's specifications. In particular, infrared spectroscopy is the most powerful test for confirming the identity of small molecules and drug products. As stated in the USP <197>, "the IR absorption spectrum of a substance [...] provides perhaps the most conclusive evidence of substance identity that can be achieved from a single test". FTIR results can be used to compare several specific peaks in the IR spectrum with those of a reference standard, thus establishing solid acceptance criteria.
Extractable’s & Leachable’s
The closure systems of containers (vials, syringes, bottles for commercial products etc.) intended for use in pharmaceutical applications could contribute significantly to the increase of impurities in the final product. Therefore, chemical characterisation of Extractables and Relargables (E/R) should be considered to identify the substances and components that generate them. The testing of extractables and leachables (E&L) is therefore crucial for the release of the product.