Disinfectants and Sanitizers
All disinfectants designed to kill or reduce microorganisms, such as bacteria and fungi, must have efficacy data to demonstrate their ability to kill them. EPA has specific performance criteria to evaluate the efficacy of products used in public spaces, specifically disinfectants used to control microorganisms in 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.
According to the U.S. Environmental Protection Agency (EPA), microbial pests can be divided into two independent categories:
- Microbial pests (microorganisms) that can be considered as agents that can pose a threat to human health. In respect to making claims through the EPA, these types of microorganisms are classified as public health claims.
- Alternative microorganisms that are categorized as non-public health claims whereas the transmission, or presence most likely does not lead to infections or disease in humans.
Disinfectant and Sanitizer test substances are classified as products that can kill (disinfection) or reduce (sanitization) microorganisms on specific environmental surfaces and areas.
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.
Microbac can test high-level disinfectants that are used to treat sensitive medical devices, such as endoscopes.The FDA requires evaluating test products at their minimum recommended concentration using a broad spectrum of efficacy testing, including AOAC methods as well as simulated and in-use testing.
Methodologies and Claims
The EPA has published guidelines for public health claims that outline the methodologies and performance criteria required based on the type of product and types of surfaces treated. These guidelines can be found in the EPA Product Performance Test Guidelines, OCSPP 810.2000.
The EPA has a published guideline for non-public health claims, referred to as Pesticide Assessment Guidelines – Subdivision G: Product Performance.
These guidelines typically include the following aspects for specific claims:
- Microorganisms required to challenge the test substance.
- The official test methods used to evaluate the product performance and compliance with methodologies used to validate the EPA’s performance requirements.
- Reporting requirements.
Regulatory Bodies
Agencies that regulate most disinfectants and sanitizers include, but are not limited to the:
- U.S. Environmental Protection Agency
- Health Canada
- European (EU, BSI and other standards)
- Other International Agencies
In Vitro Toxicology
We perform toxicity testing and toxicological screening studies in vitro on a variety of products, including but not limited to pharmaceuticals, biopharmaceuticals, medical devices, cosmetics, personal care products, disinfectants, special chemicals, and tobacco. Over the past few decades, testing toxicity using non-animal methods (in vitro, ex vivo, and in silico) have become more and more popular thanks to the advancement of science, collaborative development and validation efforts, consumer pressure and regulatory acceptance.
Pre-treated textiles/surface materials
This type of testing is primarily used for fabrics, such as those found in surgical face-masks, that have been treated with some sort of antimicrobial product or substance. Testing is based on AATCC 100 but can be customized based on the needs of the client. In this context, virus is misted onto the fabric and allowed to sit for a specified contact time. The entirety of the fabric sample is added to an extraction buffer and squeezed to extract any surviving virus. Results are compared to the recovery from a glass carrier to determine efficacy. Often, a similar product without microbial treatment is used as a reference control to help determine the efficacy of the test fabric.This test can be modified to evaluate treated textiles for antibacterial or antifungal activity based on a similar design.
References and Guidelines
- U.S. Environmental Protection Agency Product Performance Test Guidelines, OCSPP 810.2000 Series Guidance for Efficacy Testing
- Pesticide Assessment Guidelines – Subdivision G: Product Performance, B.A. Schneider. U.S. Environmental Protection Agency, Washington, D.C., September 1982 Health Canada
- Air sanitizers
- Analytical chemistry
- Antimicrobial efficacy (EPA, FDA, EN and other international)
- Antiviral efficacy (EPA, FDA, EN and other international)
- High level disinfectants 510(k)
- In vitro Toxicology
- Laundry sanitizers
- Pre-treated textiles
- Pre-treated surface materials
- Residual (long lasting) efficacy
- Soft surface textile method
- Water purifiers
Contact Us
Have questions or need expert testing solutions? Reach out to Microbac today, and let our team provide you with reliable and accurate testing services tailored to your needs. We’re here to support your business with trusted expertise.