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Antimicrobial Efficacy for EPA Disinfectants and Antiseptics

All pesticides designed to kill or reduce microorganisms such as bacteria and fungi must have efficacy data proving their ability to kill these pests. 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, quality and compliance, as well as a large micro-organism library makes us a trusted contract testing laboratory.

Antimicrobial Efficacy for FDA Health Care Topical Antiseptics

Healthcare antiseptics are antimicrobial agents that are intended to reduce the number of microorganisms on the skin. Healthcare antiseptics are drug products intended for use by healthcare professionals in a hospital setting or other care situations outside the hospital.  Efficacy testing for antiseptics includes evaluation of requirements for patient preoperative skin preparations, surgical hand scrubs and rubs, and health care personnel hand washes and rubs (sanitizers).

Virucidal Efficacy for EPA Disinfectants

All pesticides designed to kill or reduce microorganisms such as viruses must have efficacy data proving their ability to kill these organisms. 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, quality and compliance, as well as a large micro-organism library makes us a trusted laboratory partner of choice. 

Antiviral Efficacy for FDA Products

Antiviral efficacy testing may be required for topical antiseptic products, antiviral drugs or viral-blocking devices, high-level disinfectants for endoscopes and other critical devices, blood glucose monitoring devices (BGMS), contact lens-care solutions, and specific medical devices that seek an antiviral efficacy claim, such as treated face masks, surgical gloves, barrier creams, condoms, and sheathing products, etc. Microbac has extensive experience performing in vitro and in vivo tests for these products per FDA, ISO, OECD, and other guidelines for regulatory submission.

Disinfectant Validation / Cleaning Efficacy

Bio/pharmaceutical manufacturers are required to maintain sterile areas for production. The FDA requires that all cleaning and disinfection procedures in these areas and on these surfaces, using EPA-approved products, must be validated. Testing involves evaluating products and procedures used to decontaminate devices and multiple surface areas within assigned sterile spaces.

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Challenge Studies

A product may have intrinsic factors that inhibit microbial growth, or formulators can add antimicrobial preservatives to protect them from microbial growth.  When preservatives are added, the goal is to add only as much as is needed since all antimicrobial agents are considered toxic substances. Microbac has experienced microbiologists who have been performing the USP <51> Antimicrobial Effectiveness test for over 20 years. We assist both small and large processors in the development of effective antimicrobials in a wide range of products.