- Swiss testing laboratory
AOAC 966.04 - Evaluation of Sporicidal Activity of Disinfectants
Hassle-free testing experience
Need to get a product tested? No worries! To and fro logistics are on us; we collect your products, test them and, deliver them back to you.
Summary
AOAC 966.04 is a qualitative carrier test that evaluates the sporicidal activity of disinfectants intended for hard, non-porous surfaces by using resilient test organisms like Bacillus subtilis and Clostridium sporogenes.This test method is recognized by EPA and FDA and widely used to provide data to support regulatory submissions for sporicides and sterilants in the US and other international markets.
Related tests for you
Quick understanding of the test
AOAC 966.04 - Evaluation of Sporicidal Activity of Disinfectants
AOAC 966.04 is a carrier test that qualitatively evaluates the sporicidal activity of disinfectant used on hard, non-porous surfaces.
Application
Applicable to water-soluble powders and non-volatile liquid products intended for disinfection of hard surfaces.
Mandatory test strains
- Bacillus subtilis
- Clostridium sporogenes
- The test starts inoculating test carriers with spore suspensions and and exposing them to the test product for a specified contact time.
- Treated carriers are transferred to a recovery medium, followed by incubation to qualitatively assess growth.
- Offers a standard method to assess the sporicidal activity, providing consistent and reliable results.
- Critical for compliance set by regulatory bodies like EPA (Environmental Protection Agency).
Turnaround Time
Passing criteria
Do you have a product that needs testing?
What is AOAC 966.04?
AOAC 966.04 is a test method used to evaluate the efficacy of water soluble powders and non-volatile liquid products for their sporicidal property.It evaluates efficacy against highly resistant spore forming bacteria such as Bacillus subtilis and Clostridium sporogenes, making it relevant for products intended for high-level disinfection and sterilant type claims. AOAC 966.04 is a carrier based method in which spores are dried onto s carriers and then exposed to the disinfectant for a defined contact time, allowing practical contamination conditions for assessing sporicidal efficacy.
AOAC 966.04 Test Method Overview
This test method uses two types of test carriers:
- Porcelain penicylinders
- Silk suture loops
Mandatory test organisms
Bacillus subtilis (ATCC 19659) and Clostridium sporogenes (ATCC 3584)
Inoculum requirements
The inoculum size should be between 1.0ร105 to 1.0ร106. spores/carrier.
Carrier inoculation and drying
Carrier surfaces are contaminated with spore suspension and are exposed to test products for specified contact times.
Contact time and neutralization
At the end of contact time, dried contaminated carriers are immediately transferred to a recovery medium enriched with neutralizing compounds.
21-Day incubation & growth assessment
- Recovery medium is incubated for a period of 21 days. This incubation period allows for a comprehensive qualitative assessment of any potential growth that may still be present after disinfectant treatment.
- While evaluating, growth indicates survival of spores and failure of the test product. No growth of spores indicates that the product has passed the test.
Products eligible for AOAC 966.04 test
AOAC 966.04 is applicable for the following type of products:
- Water soluble powders
- Non-volatile liquid products
Importance of AOAC 966.04 Test
Clostridium sporogenes and Bacillus subtilis are considered one of the major contributors for spreading infections and disease outbreaks within hospital settings. Both bacteria can form endospores, allowing them to endure harsh conditions and persist for extended periods. As a part of robust hygiene practices, disinfectants possessing sporicidal action should be employed to effectively eliminate these endospore-forming microbes.
Disinfectants labeled with sporicidal claims are registered and approved by regulatory bodies like the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA). AOAC 966.04 method is designed for compliance reporting of sporicidal disinfectants under EPA and FDA regulatory authorities.
Regulatory importance
AOAC 966.04 is a standard testing guideline for the registration of disinfectants that claim sporicidal activity as per US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) .It is widely used in the US for generating efficacy data for regulatory submissions and product registrations and also referenced by EU and international markets.
AOAC 966.04 vs AOAC Use Dilution Test
Feature | AOAC 966.04 | AOAC Use Dilution Test (955.14, 955.15, 964.02) |
Purpose | Evaluates sporicidal activity against resistant bacterial spores | Evaluates disinfectant efficacy against vegetative bacteria and fungi |
Target microorganisms | Bacillus subtilis, Clostridium sporogenes | Staphylococcus aureus, Salmonella enterica, Pseudomonas aeruginosa, and Trichophyton mentagrophytes |
Test carrier material | Porcelain penicylinders and/or silk sutures | Stainless steel penicylinders |
Incubation period | 21 days | Short incubation, typically 48 hours |
Regulatory relevance | Required for sporicidal or sterilant claims | Required for hospital and general disinfectant claims |
Applicable Industries | Healthcare, surgical areas, sterilant-level products | Routine surface disinfectants and hospital cleaners |
Why choose our lab for AOAC 966.04 testing
At MIS, we specialize in evaluating sporicidal efficacy of disinfectants in accordance with AOAC 966.04 method. Our expert microbiology team performs the test rigorously providing reliable scientific data to support your claims. Under our AOAC testing portfolio, we also perform AOAC 965.12 test for tuberculocidal activity of disinfectants. Give this CTA more specific to AOAC 966.04
Request AOAC 966.04 testing
To get a quote on AOAC 966.04 testing, talk to our experts today
Frequently Asked Questions
DR. Martinoz Scholtz
AOAC 966.04 is a sporicidal activity test designed for evaluating efficacy of water-soluble powders and non-volatile liquid products. AOAC 966.04 is recommended by regulatory authorities FDA and EPA as part of the registration process of sporicidal disinfectants products.
No, AOAC 966.04 is a qualitative test method as it confirms results based on presence or absence of growth of spores.
The 21 day incubation period allows for delayed spore recovery i.e. giving time for dormant spores to germinate and grow.
Yes, AOAC 966.04 is an EPA recognized test standard for s sporicidal claims.
AOAC 966.04 evaluates the ability of a disinfectant to kill bacterial spores on a carrier surface.
This test method lists Bacillus subtilis and Clostridium sporogenes as the mandatory test organisms. Additional strains can be added upon requirement.
AOAC 966.04 test is applicable to water-soluble powders and non-volatile liquid products intended for disinfection of hard surfaces.
Spores are dried onto carriers, exposed to the test product for a defined contact time, neutralized, and then incubated in recovery media. Carriers are observed for microbial growth over 21 days.
Sporicidal activity is the ability to completely inactivate bacterial spores, while intermediate disinfection does not reliably kill spores and targets less resistant organisms.
AOAC 966.04 test takes 4-5 weeks to complete.
A passing result requires no microbial growth on any carrier after the incubation period.
AOAC 966.04 evaluates sporicidal activity, whereas AOAC Use Dilution test evaluates bactericidal performance against vegetative bacteria. The Use Dilution Test provide quantitative assessment , whereas AOAC 966.04 is a qualitative test.
AOAC 966.04 is a qualitative carrier test that helps assess sporicidal activity of disinfectants which are claimed to be sterilant. Whereas, AOAC 965.13 determines the effective disinfectant concentration for swimming pool water by comparing bacterial reduction against a chlorine control.
Bacterial spores that survive on surfaces can lead to serious infections. Sporicidal activity testing verifies if a disinfectant is effective against these highly resistant organisms simulating real-world conditions.
Meet the best of the blend of
R&D, Efficacy Testing,
Innovation and Passionate
Experts at MIS.
Explore More
Did you know there are
Antibacterial testing of disinfectants plays
Antimicrobial testing is important to
Antibacterial efficacy testing is an
Letโs face it, we are
