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Ethylene Oxide Residual Analysis
Ensuring patient safety is paramount when sterilizing medical devices. Among sterilization methods, ethylene oxide (EO) is widely used due to its compatibility with a broad range of materials. However, residuals such as ethylene oxide, ethylene chlorohydrin (ECH), and ethylene glycol (EG) can remain on the devices post-sterilization. These residues must be minimized to prevent harm during product use.
MTT Assay
MTT Assay is a colorimetric assay that measures the metabolic activity of cells as an indicator of their viability. By leveraging the cell's natural enzymatic processes, this assay transforms a yellow tetrazolium salt (MTT) into insoluble purple formazan crystals. These crystals only form in cells with active metabolism, offering a direct correlation between formazan production and the number of living cells.
Subacute Systemic Toxicity
Subacute Systemic Toxicity is a critical aspect of health risk assessment that evaluates the effects of exposure to harmful substances over a period longer than immediate (acute) but shorter than chronic. This type of toxicity is essential in occupational safety, environmental health, and the development of medical and pharmaceutical products, as it helps to identify potential health risks that emerge from prolonged exposure.
GC/MS Identification of Impurities
Gas Chromatography-Mass Spectrometry (GC/MS) is a powerful analytical technique widely used to identify and quantify impurities in various fields such as pharmaceuticals, environmental studies, and food safety. By combining gas chromatography (GC) and mass spectrometry (MS), GC/MS provides detailed and reliable data crucial for ensuring product purity and safety.
LAL & Bacterial Endotoxin Routine Determination
Routine LAL (Limulus Amebocyte Lysate) testing and bacterial endotoxin determination are crucial for maintaining product safety and quality. By consistently performing these tests, companies ensure that their products meet regulatory standards, protect patient health, and uphold their reputation.
Acute Systemic Toxicity
Acute Systemic Toxicity involves the immediate health risks posed by exposure to harmful substances. It's a critical concern in occupational safety and environmental health, emphasizing the importance of rapid intervention and stringent safety measures.
Identification of Potential Extractables & Leachables
The identification of potential extractables and leachables (E&L) using GC/MS (Gas Chromatography/Mass Spectrometry) is a critical process in ensuring the safety and compliance of Pharmaceuticals and Medical Devices that come into contact with humans.
Bisphenol Testing
Bisphenols are compounds used in the industrial manufacture of plastics, as monomers of polycarbonate or as additives in epoxy resins. They form a large family made up of many substances that have similar chemical structures and uses.
Phthalate Analysis Testing
Phthalates are a series of widely used chemicals that demonstrate to be endocrine disruptors and are detrimental to human health. Phthalates can be found in most products that have contact with plastics during producing, packaging, or delivering.
Haemocompatibility
Haemocompatibility, also known as hemocompatibility, is a crucial aspect of biocompatibility testing for medical devices that come into contact with blood. It evaluates the interactions between the medical device and blood components to ensure that the device does not adversely affect blood or cause harmful reactions when used as intended.