Staci Horme's Blog (11)

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the launch of its new Real-time Aging Testing services to accurately assess the long-term performance and integrity of medical device packaging under real-world storage…

STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its new Transportation and Distribution Simulation Services for the medical device…

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.…

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…

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…

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…

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…

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…

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…

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…

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…