Why Your Products Need APE Testing? An antimicrobial or preservative is defined as a chemical substance that will kill microorganisms or inhibit the growth of microorganisms, usually added to nonsterile products to protect them from microbiological contamination. If your product will be on the market, it is advised that it has been validated to be free from microbiological contaminants through Antimicrobial Preservative Effectiveness (APE) Testing. Antimicrobial Preservative Effectiveness ...

What is Antibiotic Potency Test? A microbiological potency assay measures the bioactivity or potency of an antibiotic by the degree of growth repression on susceptible microorganisms at different concentrations. All antibiotic products must go through potency testing prior to market release. Both the EP and the USP require testing of antibiotic potency using microbiological assays for some products. Compared with measuring the potency of an antibiotic chemically, assessing the potency of a...

Biocompatibility evaluation of breathing gas pathways in medical devices is a powerful tool for the evaluation of contaminants from the air emitted from the device for Volatile Organic Compounds (VOCs) and particulate matter when the gas pathway is intended to contact a patients’ respiratory tract. Standard for Biocompatibility Evaluation of Breathing Gas Pathways in Medical Device "Chemical Characterization of medical device materials", part eighteen of the Biological evaluation of medica...

The biocompatibility systemic toxicity tests are in vivo systemic tests used to evaluate the impairment or activation of a system, rather than the impairment of individual cells or organs. Acute systemic toxicity tests and pyrogenicity tests are included in the systemic toxicity tests. Acute Systemic Toxicity Testing Acute toxicity is considered to be the adverse effects that occur after administration of a single dose or repeated doses of a test article given within 24 hours. Acute system...

The Biocompatibility Subacute and Subchronic Toxicity test is used to evaluate the toxicity effects likely to arise from repeated exposures would have on a patient, including any compound toxicity effects. This test determines the systemic effect of repeated doses of materials or their extracts for no less than 24 hours and no greater than 10% of the total lifespan of the test animal. Subacute toxicity (repeat-dose toxicity) focuses on adverse effects occurring after a single or repeated expo...

Cytotoxicity testing is a sensitive method to assess the biocompatibility of a material extracted through a specific cell culture media following exposure of the extracted fluid to L929 cells. This test is performed on raw materials in the manufacturing process, all medical devices contacting patients, and devices undergoing a sterilization validation. STEMart provides a wide range of in vitro cytotoxicity assays to qualitatively and quantitatively evaluate the ability of medical device to da...

Chemical Characterization is a powerful methodology for addressing biocompatibility endpoints, providing a risk assessment of biocompatibility using chemical, biocompatibility, and patient exposure data. Chemical Characterization involves the extraction of the device with various solvents, chemical analysis of compounds extracted from the device, and an evaluation of the toxicological risk associated with the patient exposure to the extracted compounds. Standard for Chemical Characterization ...

Sensitization testing is used to assess the potential of chemicals and medical devices to cause a delayed hypersensitivity reaction following a single or repeated exposure to the body. Sensitization is one of the three most common biocompatibility tests required to ensure the safety of medical devices. "Tests for irritation and skin sensitization", part ten of the Biological evaluation of medical devices standards (ISO 10993-10), gives out the general considerations that should be taken into ...

Irritation represents local tissue inflammation response to chemicals, without a systemic immunological component, and irritation is characterized by inflammation, redness, swelling, heat, or pain. Irritation testing is used to assess the potential of a medical device to cause an immediate irritation reaction in the skin, mucosal, or ocular tissues following a single or repeated exposure to the body. Irritation is one of the three most common biocompatibility tests required to ensure the safety ...