STEMart

STEMart Launches Comprehensive Medical Device Packaging Solutions

STEMart announces the launch of its Packaging Solutions for the pharmaceutical and medical device industries. STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its comprehensive suite of Packaging Solutions to meet the unique needs of the pharmaceutical and medical device industries. These services are designed to ensure the quality, sterility, and regulatory compliance of medical devices throughout t... READ MORE Posted September 05, 2024 at 02:27 AM

STEMART REVOLUTIONIZES MEDICAL DEVICE DEVELOPMENT

STEMart proudly announces the launch of its new Medical Device Prototyping Services. STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its new Medical Device Prototyping Services. Using the latest technologies, these reliable prototyping solutions can help medical device companies streamline the development process and test new products quickly and cost-effectively, saving time and resources. Prototyping i... READ MORE Posted July 04, 2024 at 02:34 AM

Antimicrobial Preservative Effectiveness (APE)

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 throughAntimicrobial Preservative Effectiveness (APE) Testing. Antimicrobial Preservative Effectiveness... READ MORE Posted June 06, 2024 at 01:24 AM

Antibiotic Potency Test

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 an a... READ MORE Posted May 10, 2024 at 12:26 AM

Breathing Gas Pathways in Medical Devices

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 medi... READ MORE Posted April 07, 2024 at 10:27 PM

Acute Systemic Toxicity & Pyrogenicity

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... READ MORE Posted March 10, 2024 at 11:04 PM

Subacute & Subchronic Toxicity

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... READ MORE Posted February 19, 2024 at 10:23 PM

Chemical Characterization

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 Characteriza... READ MORE Posted January 19, 2024 at 12:03 AM

Sensitization (ISO 10993-10)

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 ... READ MORE Posted December 18, 2023 at 07:11 PM

Irritation (ISO 10993-10)

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... READ MORE Posted November 21, 2023 at 06:35 PM