Disinfection Process Validation
Disinfectant tests are used to validate sanitizing agents for effectiveness against organisms, which is an increasing area of concern to manufacturers and regulatory agencies. Disinfectant efficacy must be established before a new disinfectant can be put on the market. Additionally, manufacturers must validate disinfectant regimens for cleanroom and other controlled areas.
Materials tested typically include household and industrial disinfectants, sporicides, fungicides and hand sanitizers. Disinfectant testing is conducted per many different standards including AOAC Chapter 6 tests, ASTM E 2315, USP General Chapter 1072 and ASTM E 26140. We are highly experienced in performing general disinfectant efficacy tests to establish kinetic kill curves for a large variety or organisms.
- AATCC Method 147
- AOAC Chapter 6
- ASTM E2315
- USP General Chapter 1072
- ASTM E26140
Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.
|Code||Test||TAT (days)||Request Quote|
|DCT101||Disinfectant Coupon Test: Protocol & Report Fee||Add|
|DCT110||Disinfectant Coupon Test: Study Fee||0||Add|
|DIS115||General Kill Time Test Fee: Per variable (time pts, orgs., product)||Add|
|DIS850||Disinfection: ISO-FDA Regimen Test for Disinfection of Contact Lenses||0||Add|
|DIS860||Disinfection: ISO-FDA Stand-Alone Test for Disinfection of Contact Lenses||0||Add|
DCT101 - Disinfectant Coupon Test: Protocol & Report Fee
Standard TAT not available for this product
DCT110 - Disinfectant Coupon Test: Study Fee
DIS115 - General Kill Time Test Fee: Per variable (time pts, orgs., product)
Standard TAT not available for this product
DIS850 - Disinfection: ISO-FDA Regimen Test for Disinfection of Contact Lenses
DIS860 - Disinfection: ISO-FDA Stand-Alone Test for Disinfection of Contact Lenses
DCT110: Coupons should be approximately 1 x 3 inches in size and less than ¾ inch thick. To be supplied by sponsor.
Study OutlineDisinfectant Regimen Validation:
The disinfectant validation test is to ensure that the cleaning and disinfectant procedure conducted for a controlled room is sufficient to remove, destroy or de-activate microbial contamination on objects or surfaces. The USP chapter <1072> provides guidance on a disinfectant regimen in relation to the reduction of viable microorganisms and spores. A validation provides information about the current environment, as environmental isolates are commonly used, and it verifies that the cleaning and disinfectant regimen developed during the validation is effective and appropriate for the surfaces and controlled environment. The risk of a manufacture not conducting a cleaning and disinfection validation may lead to an FDA 483, warning letter, or the possible release of unsafe product. Nelson Laboratories has the capability to customize protocols to meet clients’ hard-surface disinfectant validation needs.
In the Disinfectant test procedure, representative surfaces that are scaled down for laboratory testing are referred to as “coupons.” The test coupons must be sterilizable prior to testing.
The sterile coupons are challenged with 10 – 30 µL of culture or spore suspension. The suspension is spread evenly over a one-square-inch area and then dried. The challenge culture may include an organic soil such as 5% blood serum to further the difficulty of disinfection, upon request.
The actual test procedure involving the application of disinfectant onto the coupon surface can vary greatly and are adjustable to suit testing needs. Examples of disinfectant application include spraying directly or wiping with a sterile towel saturated with the disinfectant. Another variable aspect is the exposure time during which the disinfectant is in contact with the inoculated coupons.
Following the disinfection procedure, the treated coupons are aseptically transferred to neutralizing media and extracted to remove any surviving microorganisms. . The number of surviving organisms are enumerated and percent and log reduction values are calculated. The panel of organisms selected for this test may also vary. It is recommended that a spectrum of representative organisms be selected 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 perform the test using environmental isolates.
Neutralization validation of the test disinfectants and extraction efficiency testing are included in every test for each organism/disinfectant/coupon combination tested, as well as positive and negative controls.