Antimicrobial Efficacy Testing

Antimicrobial Efficacy for 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.

Disinfectant Qualification

Biopharmaceutical manufacturers are required to maintain sterile areas for production. The FDA requires that all cleaning and disinfection procedures using disinfectants and sanitizers in these areas and on these surfaces must be validated.

Testing involves evaluating products and procedures used to decontaminate devices and multiple surface areas within assigned sterile spaces.

Testing is based on USP 1072 but can be customized based on the needs of the client.

High-Level Disinfectants

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.

Treated Textiles and Surfaces

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.

Clinical Antimicrobial Efficacy Testing

Antimicrobials require efficacy testing, which is carried out through industry standards based on FDA requirements, to validate their intended use and to substantiate claims. Microbac is the top lab of choice conducting both in vitro and in vivo clinical efficacy testing. 

A pool of 1,000+ volunteer subjects and lab operation seven days a week lab facilitate our rapid turnaround time for pilot and pivotal clinical trials.

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.

Microbac offers these specialized tests:

• EPA “six-pack”
• Genic toxicity
• Cytotoxicity
• Skin toxicity
• Ocular toxicity

Virucidal Efficacy

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.

Viral Clearance Studies

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, selecting representative challenge viruses, direct testing of the product at various stages of production, and incorporating and validating viral inactivation and removal steps (i.e., “viral clearance” studies).

Air Biology

Microbac is one of the leading airborne microorganism research facilities in the world, having added a technologically advanced aerobiology laboratory in which potential pathogens are subjected to thorough customized analysis to determine the efficacy of client developed agents.

Residual DNA

When animal tissues are used for treatment of human disease, it is important to make sure animal DNA is removed to a sufficient level, as defined by the FDA, depending on the intended use of the tissue. In this type of study, the tissue is thoroughly digested using heat, a strong detergent, and enzymatic action overnight. Present DNA is extracted using a commercial kit.

Microbac can quantify available DNA using a dye that binds to dsDNA (double-stranded DNA), studying it along with a standard curve of known DNA concentration. OD260/280 is usually also taken for these tests to quantify the purity of any present DNA.

Adventitious Virus

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.

Mycoplasma

Cell cultures are often contaminated with small bacteria known as mycoplasma. If the cells are to be used for human treatment or to make a product, the FDA requires they be tested for the absence of mycoplasma routinely to be sure the final product will be safe for human use.  Microbac is highly experienced with this type of testing.

Mycoplasma can be detected using any of the following methods offered by Microbac:

• Culture
• Vero cell co-culture
• PCR targeting regions of DNA specific to mycoplasma – the most common and readily available of these detection pathways