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GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample.

Bacterial Endotoxins Validation is a critical process in the pharmaceutical industry that ensures the safety and quality of products. Endotoxins from gram-negative bacteria are the most common cause of toxic reactions resulting from contamination of pharmaceutical products.

GC/MS Residual Analysis is crucial primarily for safety reasons. Residual solvents can be harmful or toxic. Even if they are not directly harmful, they can react with other substances in the product to form harmful compounds. Therefore, it’s essential to identify and quantify them to ensure the safety of the product.

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.