Disinfectant Efficacy Studies

MQA Microbiologists have many years of experience performing disinfectant efficacy studies using bacteria, fungi, and viruses. We are FDA registered and have been inspected for GMP testing services.

All disinfectant, sanitizer or sporicidal solutions must pass testing requirements by the EPA, FDA, and EU regulatory bodies in order to be licensed. Testing requirements for licensing are very limited and specific and do not represent actual use. FDA requires that drug and medical devices manufacturers validate the disinfectant to demonstrate the efficacy under use conditions and microbial flora specific to the manufacturing site. European disinfectant testing requirements are indicated in CEN/TC 216 (European Committee for Standardization Technical Committee 216 – Chemical Disinfectants and Antiseptics).

Studies can be customized to meet EPA, FDA, and EU requirements. We would be happy to discuss your project with you and provide you with a quote.

Disinfectant and Sanitizer Efficacy Testing:

• USP <1072> Disinfectant studies using coupons
• AOAC Use Dilution Test for Liquid Products
• AOAC Germicidal Spray Products Test
• EN 1040 Basic Bactericidal Activity of Chemical Disinfectants
• EN 1275 Basic Fungicidal Activity
• EN 1276 Quantitative Suspension for Bactericidal Activity
• EN 1650 Quantitative Suspension for Fungicidal Activity
• EN 13697 Quantitative Surface Test of Bactericidal Activity
• Custom Time Kill Studies
• AOAC Method 955.17 Fungicidal Activity Method
• AOAC Method 960.09 Germicidal and Detergent Sanitizing Action of Disinfectants
• AOAC Method 960.09 Germicidal and Detergent Sanitizing Action of Disinfectants
• AOAC Method 961.02 Germicidal Spray Method
• AOAC Method 966.04 Sporicidal Activity of Disinfectants
• AOAC Method 966.04 (Modification) Sporicidal Method to Determine Efficacy of Products Used in Aseptic Filling Applications
• AOAC Use Dilution Test for Liquid Disinfectants (Methods 964.02, 955.14 and 955.15)
• Disinfection Qualifications for Clean-Room Disinfectants
• AAMI Method TIR12 / AAMI TIR30 Low, Intermediate and High-Level Disinfection Validation for a Reusable Medical Device
• Re-Use Stress Testing and Evaluation of Disinfectants
• AOAC Method 955.16 Available Chlorine in Disinfectants

Disinfectant Virucidal Efficacy Studies:

• Virucidal Efficacy Tests
• Virucidal Surrogate Efficacy Tests
  • Example of some viruses used: HIV, Herpes, Influenza, Polio, Parainfluenza, Norovirus, Hepatitis
• EN 14476 Quantitative Suspension Method for Virucidal Activity
• EN 14675 Quantitative Suspension Method for Virucidal Activity of Chemical Disinfectants & Antiseptics used in the Veterinary Field
• Canadian Virucidal Efficacy Test
• USP <1072> Disinfectant Qualification Testing for Antiviral Activity
• ASTM E1052 Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension ASTM E1053, Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces

Disinfectant Testing Standards ( USA )

• AOAC
  • Carrier test
• USP <1072> Disinfectants and Antiseptics
  • Kill time
  • Surface coupons

Disinfectant Testing Standards ( EU )

• CEN/TC 216 (European Committee for Standardization Technical Committee 216 – Chemical Disinfectants and Antiseptics)
  • Phase 1: Basic Suspension test to examine bacterial and fungicidal activity.
  • Phase 2:
    • Step 1: Suspension test to examine bactericidal, fungicidal, or sporicidal activity under laboratory conditions appropriate to its intended use (under conditions representative of practical use).
    • Step 2: Handwash, Handrub, and Surface tests
  • Phase 3: Field tests under practical conditions