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Contamination Control is a critical aspect of quality assurance in various industries, particularly those related to healthcare. It encompasses a set of practices aimed at maintaining a clean and sterile environment to prevent the introduction, growth, or spread of contaminants.

Inductively Coupled Plasma Mass Spectrometry, often referred to as ICP-MS, is a highly versatile analytical technique used for the detection and quantification of many elements. The technique uses an inductively coupled plasma to produce ions from a sample. These ions are then separated and detected by the mass spectrometer.

Bioburden, also known as microbial limit testing, is a quality control process that detects and quantifies microbial contamination of a product at different stages of production. It’s performed on pharmaceutical products and medical products for quality control purposes.

Bioburden Routine Determination is a process used to measure the total microbiological population on a medical device or pharmaceutical article prior to sterilization. This process is crucial for ensuring the sterility of these products.

Biocompatibility testing is a critical part of the safety evaluation process for medical devices. One of the key tests in biocompatibility testing is the irritation or intradermal reaction test. This test is designed to evaluate the potential of a medical device to cause irritation to the skin or other tissues.

Sensitisation testing ensures the safety of medical devices by assessing their compatibility with biological systems and their potential to cause harm or adverse reactions.

Certain regulatory bodies require a toxicological assessment of extractables and leachables, for certain products, to establish the device’s safety limits of these impurities. ISO 10993-17:2023 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.

Risk mitigation through testing in the biocompatibility scenario is a crucial step in the evaluation of medical devices. It involves assessing the biocompatibility of the materials and processes used in the device by taking a risk-based approach to their biological safety evaluations.

A Biological Evaluation Plan (BEP) is an essential step in the medical device production process. This plan is aligned with the ISO 10993, the international series of standards for the biological evaluation of medical devices.

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.