Microbac provides comprehensive analytical testing services for regulated antimicrobial products, including antimicrobial pesticides, topical antiseptic drugs, and liquid and impregnated medical devices. Throughout the product life cycle, we collaborate with your team to help navigate the complex regulatory process and help support your testing needs. Technical expertise in microbiology, chemistry, toxicology, virology, and molecular biology testing provides full-spectrum, single-source support to accelerate your time to market.
All disinfectants designed to kill or reduce microorganisms, such as viruses, must have efficacy data proving their ability to kill these organisms. The EPA has specific performance criteria to evaluate efficacy of products used in public areas, specifically disinfectants used to control microorganisms in areas of the inanimate environment that are infectious to humans.
Microbac’s decades of experience, ISO 17025 accredited quality system, and GLP compliance, as well as a large micro-organism library, make us a trusted contract testing laboratory.
Biopharmaceutical products have an inherent risk of transmitting infectious viruses due to variables in source materials, manufacturing processes and the route of administration employed throughout production. In order to mitigate the viral contamination risk, we work with client project teams on a multi-faceted, complementary approach, including selecting and testing the starting materials, direct testing of the product at various stages of production, and incorporating and validating viral inactivation and removal steps (i.e., “viral clearance” studies).
To help mitigate the viral contamination risk, the sponsor’s raw material is put through a direct testing process in order to detect any viral contaminants present.
We collaborate closely with our clients’ teams to choose and evaluate the raw materials and on direct testing of the product intermediates throughout the production process.