Disinfectants require approval from the regulatory authorities regarding the efficacy, functionality, and toxicity before introducing the product in the market.
In order to market the disinfectants, manufacturers must evaluate the new formulations as per the standard international guidelines for the microbicidal (bactericidal, fungicidal, sporicidal or virucidal) efficacy. To get approval from the regulatory bodies, application must be filed along with the test reports with the claimed efficacy data. There are several regulatory bodies such as FDA, EPA, BPR, AOAC, EN, EU GMP, ASTM that help to demonstrate disinfectant products and their efficacy claims.
FDA (U.S. Food and Drug Administration) issues guidelines for liquid chemical sterilants and high level disinfectants used for critical and semi critical medical devices as well as air purifiers intended for medical purposes.
In the United States, liquid disinfectants (chemical germicides) are registered and regulated by the U.S. Environmental Protection Agency (EPA) under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, any liquid sterilant products or chemical substances intended to disinfect, sanitize, reduce, or mitigate microbial growth on inanimate surfaces are registered and classified as “antimicrobial pesticides”.
EPA requires test methods from AOAC (Association of Official Analytical Chemists) to validate microbicidal (sporicidal, germicidal or fungicidal) claims of disinfectant products.
For water soluble powders or liquid products AOAC Use-Dilution Method (955.14, 955.15 and 964.02) – Tested against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa
Germicidal Spray Products as Disinfectants (GSPT) AOAC (961.02) – Tested against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa
Disinfectant Towelette Test – Tested against Staphylococcus aureus, Pseudomonas aeruginosa, and Salmonella enterica
AOAC Sporicidal Activity of Disinfectants Test – Tested against Bacillus subtilis x porcelain carrier
AOAC Fungicidal Activity Method (AOAC Method 955.17) – Tested against Trichophyton interdigitale)
AOAC Confirmatory Tuberculocidal Activity Test – Disinfectants with or without tuberculocidal claim are labeled as “intermediate-level disinfectant” and “low-level disinfectant” respectively.
American Society for Testing and Materials (ASTM) has released its guidelines for evaluation of disinfectant performance.
- ASTM E2799-22 – Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay
- ASTM E2871-21 – Standard Test Method for Determining Disinfectant Efficacy Against Biofilm Grown in the CDC Biofilm Reactor Using the Single Tube Method
- ASTM E2274-16 – Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants
- ASTM E2406-16 – Standard Test Method for Evaluation of Laundry Sanitizers and Disinfectants for Use in High Efficiency Washing Operations
- ASTM E2362-22 – Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection
- ASTM E1053 – Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
- ASTM E1052 – Standard test for testing inactivation of viruses in contaminated liquid wastes as well as determination of virucidal activity for liquid chemicals or personal care products.
In Europe, EN 14885 : 2022 presents different standards that are used to validate the efficacy claim of disinfectant products for their intended use. This pertains to products made for use in the area of human medicine, veterinary settings, and in food, industrial, domestic and institutional areas.
Working Group 1 (WG 1) – Applicable for chemical disinfectants and antiseptics to be used in areas and/or situations where disinfection is medically indicated. Area of applications are medical facilities, dental institutions, clinics of schools, kindergartens and nursing homes. It also includes the catering areas that offer direct supply of materials to patients.
Working Group 2 (WG 2) – Applicable for chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals and veterinary laboratories for analyses and research.
Working Group 3 (WG 3) – Applicable for chemical disinfectants and antiseptics to be used in food, industrial, domestic and institutional areas.
Under European Standard, disinfectant efficacy testing is divided up into three phases:
1. Phase 1 ( Basic Suspension Test)
This test determines if chemical agents present in disinfectant possess basic bactericidal, fungicidal or virucidal properties.
2. Phase 2 (Quantitative suspension test)
Phase 2 Part 1 – Test is used to determine the microbicidal activity of disinfectant under conditions which are very close to real disinfection situations/areas.
Phase 2 Part 2 – Also referred to as “carrier test”. Test used to validate the performance of disinfectant products against surface adhered microorganisms.
3. Phase 3 (Field Trial)
Applicable methodologies are yet to be developed for this.
Different Strains used in Disinfectant Testing
At MIS, we perform antimicrobial analysis for disinfectant products against different types of microorganisms like bacteria, bacterial spores, viruses, fungi, and algae.
The reference strains of microorganisms are selected based on international test standards and guidelines. Plus, clients are allowed to choose additional strains.
For more information check out : MIS microbial library
Disinfectant Testing Products
There is a wide range of disinfectant products that can be tested at MIS –
- Household disinfectants
- Hygienic handrub and handwash
- Surgical handrub and handwash
- Instrument and surface disinfectants used in medical areas
- Germicidal spray products
- Germicidal wipes
- Veterinary disinfectants
Importance of Disinfectant Testing
Disinfectant testing determines the disinfectant product’s ability to reduce microbial load in desired areas of application. Since disinfectants play a crucial role in fighting against potential pathogens and limit the chances of cross contamination in different facilities. Disinfectants are grouped into different categories based on their intended use such as disinfection in medical facilities, in house disinfection, disinfectant for veterinary areas and so on. However, in certain areas and/or situations, potency of disinfectant is affected by heavy microbial load which eventually leads to risk of infections.
Disinfectant testing is performed using international standards and guidelines to ensure products efficacy and public safety.
We offer a comprehensive array of disinfectant testing services. Microbe Investigations Switzerland (MIS)’s disinfectant efficacy testing services are compliant with EPA, EN and ASTM standards.
We are a team of microbiologists and technical experts who fully understand the customer requirements and are able to implement both standardized and customized methods that are all suitable for testing samples.
Our system is very robust and hence we are able to generate results with a high level of reproducibility and accuracy.
Any questions about finding the right standard for your disinfectant product, reach out to our experts here.