Disinfectant Testing & Antimicrobial Efficacy Studies

Manufacturers of disinfectants, sterilants, sanitisers and sanitary preparations in Australia must adhere to the requirements of the Therapeutic Good Administration (TGA). Antimicrobial manufacturers must demonstrate compliance with Therapeutic Goods Order No. 104 (TGO 104) for registration and listing purposes.

The Covid-19 pandemic proved the importance of disinfection as a means of prevention to ensure healthy communities. Mérieux NutriSciences AQ supports manufacturers by ensuring the effectiveness of disinfectants, antimicrobials and sanitisers dedicated to healthcare professionals, industries and individuals through a network of TGA licensed laboratories.

Our experts conduct a wide range of tests in compliance with TGO 104 and other international standards.

Our Disinfectant Testing & Antimicrobial Efficacy studies

Our tests allow manufacturers of disinfectants, hand sanitisers, and other antimicrobials, to receive a certificate of analysis required by TGA to sell their products to consumers, including food companies.

Our air quality testing solutions:

TGA Option tests allow disinfectant products of hospital, household, and commercial grades to support the claims of bactericidal activity. Hospital-grade disinfectants have two test options, Option A is associated with cleaning conditions while Option B is for dirty conditions. Household/ commercial grade disinfectants require an Option C test. 

Both Option A and Option B tests have two challenges against four bacterial organisms (S. aureus, E. coli, P. aeruginosa, and P. vulgaris)Option C on the other hand requires only one challenge against two organisms (S. aureus and E.coli). Note: additional organisms can be requested to be tested against the product for these TGA Option tests. Each challenge against an organism gets tested in five replicates. 

For a disinfectant product of hospital grade to pass the TGA requirements, the test must show no apparent growth in at least two out of five recovery broths of each organism challenge.  

For any TGA Option tests, we require the following information from the client: 

  • Product details
  • Test Option
  • Contact time
  • Test Temperature

Hard Surface Carrier Test (HSCT) is a qualitative disinfectant efficacy test. The test is suitable for products such as wet wipes, surface disinfectants, toilet bowl/ urinal cleaners, and more. The test follows AOAC 991.47 (Salmonella choleraesuis), 991.48 (Staphylococcus aureus), and 991.49 (Pseudomonas aeruginosa) test methods. HSCT requires the disinfectant products to pass against all three standard organismsThe product can also be tested against E. coli¸ should the client request.

The test involves carriers being inoculated with each organism (60 carriers per organism). The standard contact time is 10 minutes, but customers can choose a different contact time.

For a product to pass HSCT, the product must show no more than 2 positive growths out of 60 against S. aureus and P. aeruginosa, and no more than 3 positive growths out of 60 against S. choleraesuis. If the product requires testing against E. coli, it requires zero positive growth out of 10 carriers to meet the AOAC Hard Surface Carrier Test requirements.

For Hard Surface Carrier Tests, we require the following information from the client;

  • Product details
  • Product dilution
  • Organisms to be tested against
  • Contact time (standard is 10 minutes) 
  • Condition (clean or dirty)
  • Test Temperature

Germicidal Spray Test (GST) is a qualitative disinfectant efficacy test on hard, non-porous surfaces. The test is suitable for both spray cans and liquid sprays. The test follows AOAC 961.02 standard method. GST requires the disinfectant products to pass against three standard organisms; S. aureus, P. aeruginosa, and S. choleraesuis. Any additional organisms can be tested if requested by the customer.

The test involves glass carriers being inoculated with each organism (60 carriers per organism). Each inoculated carrier is then sprayed the number of times/ duration requested by the client. Once it reaches the contact time, each carrier is aseptically picked and then dropped to the validated neutralizer. The standard contact time is 10 minutes, but customers can choose a different contact time.

For a product to pass GST, the product must show no more than 1 positive growth out of 60 against S. aureus, P. aeruginosa, and S. choleraesuis. If the product requires testing against E. coli, it requires zero positive growth out of 10 carriers to meet the AOAC Germicidal Spray Test requirements. 

For Germicidal Spray Tests, we require the following information from the client:

  • Product details
  • Product dilution (if required)
  • Organisms to be tested against
  • Spray times/ duration (number of times or number of seconds) 
  • Contact time (standard is 10 minutes) 
  • Condition (clean or dirty)
  • Test Temperature

The antimicrobial Textile Test is a quantitative procedure to evaluate the degree of antibacterial activity in textile products. The test follows AATCC 100 standard for products such as hospital curtains, clothes, and more. For woven fabrics, this test may not be suitable as it could cause accuracy problems due to most of these products being hydrophobic. For woven fabrics, we can test the products with ISO 22196 or JSIZ 2801 (both very identical procedures). 

The test involves the test fabric being exposed to bacteria for 24 hours, followed by enumeration and calculated by per cent reduction. Although 24 hours of exposure is the standard, the tests can also involve other exposure times such as 6 hours and 12 hours, if requested by the client. 

The AATCC 100 standard test organisms are Staphylococcus aureus ATCC 6538 and Klebsiella pneumoniae ATCC 4352, but can include additional organisms upon request. ISO 22196 and JSIZ 2801 standard test organisms are Staphylococcus aureus ATCC 6538 and Escherichia coli ATCC 8739, but can also include additional organisms upon request.

Although the product can be supplied as it is, we do prefer the product to be cut in circular shapes (4.8mm to 5.0mm diameter) to reduce the time taken in cutting for the test.

For Antimicrobial Textile Tests, we require the following information from the client:

  • Organisms to be tested against
  • Type of product (woven or non-woven, hydrophobic or hydrophilic)
  • Exposure time (standard is 24 hours) 

The Antimicrobial Activity Test, commonly known as Time Kill Test, is a quantitative suspension test for the evaluation of the bactericidal and fungicidal activity. The test is ideal for chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas. Standard test methods used for Time Kill include EN 1276, EN 1275, EN 1040, and ASTM 2315. Other EN and ASTM standard methods can also be used for Time Kill tests, depending on the product type and organisms to be tested against. Standard organisms include S. aureusE. coliP. aeruginosaand E. hirae. Other/ additional organisms can be requested such as fungicidal organism C. albicans and/ or A. brasiliensis. 

The standard product concentration during the tests would be 80% when requested neat. The test can be modified to make the product concentration higher if requested (such as 90% or 100%). A product can be deemed effective when it achieves a minimum of 5 log reduction.

For Time Kill tests, we require the following information from the client: 

  • Product details
  • Product dilution
  • Organisms to be tested against
  • Contact time 
  • Condition (clean or dirty)
  • Test Temperature

We also provide tests for hand sanitiser products. The product under evaluation has to be assessed In Vitro following EN 13727 method. Once the product passes In Vitro, assessment of In Vivo must be carried by one of the following methods:

  1. Handrub studies EN1500
  2. Handwash studies EN1499 
  3. Surgical Hand scrub/ Handwash Study EN 12791 or ASTM E1174

Mérieux NutriSciences AQ can execute Disinfectant Qualification Studies for you to determine and verify the effectiveness of the disinfectants and sanitisers used in specific production environments.

Learn more about this test in the link below.

Mérieux NutriSciences AQ has a network laboratory that can provide Virucidal Tests for our clients. The viruses tested include enveloped and non-enveloped viruses, such as poliovirus, polyomavirus, and HIV. By simply clicking on the link below, you can get in touch with our sales team for enquiries or requesting Virucidal Tests, such as EN 14476.

Do you need to validate the efficacy of your disinfectants and antimicrobial products? Whether you need a TGA disinfectant test to expand your business in Australia or if you need a bespoke analysis due to a product formulation change, Mérieux NutriSciences can support you with all your analytical testing needs. 

Contact us to discover how we can help you.

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