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Bacterial endotoxins can trigger severe inflammation and death if they enter the bloodstream, cerebrospinal fluid, or intraocular fluid. Accurate detection of endotoxin levels in medical products is therefore an important part of the sterility testing process. Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.

Small Molecule Identification and Purity Testing is essential for a variety of reasons. First and foremost, it ensures the safety of the substances we interact with. Impurities in pharmaceuticals, for example, can lead to adverse effects or diminish the efficacy of the drug. Many industries, especially pharmaceuticals, are subject to strict regulations. Purity testing helps companies comply with these regulations and avoid potential legal issues.

Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and is performed in a cleanroom environment.

Medical devices are labeled with an expiration date that is supported by testing shelf-life data. 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 aging studies. There are many different endpoints that 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.

Elemental and Trace Metal Analysis is a critical part of quality control and commercial release in the pharmaceutical and medical device industry. It involves the analysis of trace metals and other elements in raw materials, active pharmaceutical ingredients (APIs), excipients, and formulations to ensure product quality and purity.

Environmental monitoring is a crucial process that helps to assess the impact of human activities on the environment and take steps to minimize any negative effects. Failure to conduct environmental monitoring can result in a lack of understanding of the environmental impact of an organization’s activities, leading to potential harm to the natural environment and human health.

Residual testing is a method of analysing the chemical residues that may remain on a medical device after it has been exposed to a sterilisation process. Residues can affect the biocompatibility, functionality and safety of the medical device, and potentially harm the patient or user. Therefore, it is important to ensure that the residues are within acceptable limits according to the relevant standards and regulations.

Plastics testing is a process that involves evaluating the compatibility, stability and integrity of plastic materials used for packaging or manufacturing medical devices that undergo sterilisation. Plastics testing can also include the analysis and screening of phthalates, which are a category of chemical compounds that are used as a form of additive in plastics.

Heavy metal elemental analysis is the process of measuring the concentration and composition of metals in biological samples. Heavy metals can be toxic and essential for living organisms, depending on their dose and bioavailability. Therefore, it is important to monitor their levels in the environment.

The Toxicological Studies provide a consistent definition of the circumstances under which it is necessary to undertake studies on new drugs and/or devices. The recommendations take into account the known risk factors as well as the intended indications and duration of exposure. Following standards such as ISO 10993 also helps to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. Additionally, following standards can increase sensitivity and reduce the number of animals required for overall safety evaluations.