Disinfectant tests are used to verify sanitizing agents for efficacy against organisms, which is an area of increasing concern to manufacturers and regulatory agencies. Disinfectant effectiveness must be ensured before a new disinfectant is released to the market. In addition, manufacturers must verify disinfectant regimes for cleanrooms and other controlled areas.
The materials tested typically include household and industrial disinfectants, sporicides, fungicides, and hand sanitizers. Disinfectant testing is done to many different standards, including the Official Analysis Methods of AOAC International and USP General Section 1072. We are well versed in conducting general disinfectant efficacy tests to generate kinetic killing curves for a wide variety of organisms.
Disinfectant validation testing aims to ensure that the cleaning and disinfecting procedure performed for a controlled environment is adequate to prevent microbial contamination on objects or surfaces. USP section <1072> provides guidance on a disinfectant regimen regarding the reduction of viable microorganisms and spores. Environmental isolates are commonly used by sponsors to validate the disinfectant program used on their premises. Validation verifies that the cleaning and disinfecting program used by the sponsor and followed during validation is effective and appropriate for the surfaces and controlled environment. The risk of a manufacturer failing to perform cleaning and disinfection validation may result in FDA 483, a warning letter, or the release of an unsafe product.
In the disinfectant test procedure, representative surfaces scaled for laboratory testing are called "coupons". Test coupons should be allowed to be sterilized.
Sterile coupons are tested with 10-30 µL of culture or spore suspension. The suspension is spread evenly over a 1 inch area and then dried. The threat culture may contain an organic soil such as 5% blood serum to further increase the difficulty of disinfection on demand.
The verification test aims to verify the actual disinfection process used by the sponsor in its facilities. EUROLAB It is well versed in many application methods and can be adjusted to the sponsor's testing needs. Examples of disinfectant application include direct spraying or wiping with a sterile towel saturated with disinfectant. The exposure time during which the disinfectant comes into contact with the inoculated coupons can also be adjusted to accommodate the sponsor's methods.
Following the disinfection procedure, the treated coupons are aseptically transferred to the neutralizing medium and removed to remove any surviving microorganisms. The number of surviving organisms are tested and counted, and percent and log reduction values are calculated. The panel of organisms selected for this test may also change with the sponsor's recommendation to use environmental isolates from specific facilities. It is recommended to select a representative organism for the test, including but not limited to: Gram-positive bacteria, Gram-negative bacteria, fungi, mold spores, and Gram-positive spore-forming bacteria. Best industry practice is to test using environmental isolates.
Neutralization validation and extraction efficiency testing of test disinfectants are included in each test for each organism / disinfectant / coupon combination tested, as well as positive and negative controls. The neutralization test proves that the test method used adequately neutralizes any antimicrobial agent in the product that might interfere with the test.
EUROLAB, with its highly expert team and internationally accredited laboratories, Disinfection Efficiency Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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