The FDA Aseptic Processing Guidance for Industry Sterile Drug Products Produced by AsepticProcessing – Current Good Manufacturing Practice September 2004 states: “routinely used disinfectants should be effective against the normal microbial vegetative flora recovered from the manufacturing facility”1.
Validex™: A Comprehensive Data Package for Disinfectant Efficacy Evaluation
subtitle added here - Author: David Collins, Principal Global Technical Consultant, Ecolab Life Sciences
11/26/2025
Article Top Heading here
"With a combination of both non-mechanical action and mechanical action (wiping) studies, the Validex™ Program provides a comprehensive data set, using a wide variety of common cleanroom surfaces and microbiological flora as summarized"
— Source, Title Pull Quote
Article Middle heading
Utilizing the available Validex™ Program, Ecolab customers can significantly reduce the burden of validation in regard to resource, time and cost.
The Validex™ Program provides efficacy data against a wide variety of standard strain organisms allowing end users to reduce the need to test these organisms themselves, and therefore prioritize validation against their in house isolates. The Validex™ data can be used by end users as part of their own validation package without concern of impartiality as all data is generated by an independent laboratory holding specific ISO 17025 accreditation for disinfectant efficacy testing. Supporting laboratory certification is issued within the data package.
The Ecolab Global Technical Team can support end users in the design and execution of any additional disinfectant efficacy study testing requirements, such as selection of applicable cleanroom materials, and selection of the appropriate in house microorganisms to be tested on each surface.
Please contact your local Ecolab Account Manager for further information on this program
references
- FDA Aseptic Processing Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice September 2004. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice | FDA
- Eudralex Volume IV. Annex 1 Manufacture of Sterile Medicinal Products, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, 2022: https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495- 194bbf0b9262_en
- EN 13697:2023 Chemical disinfectants and antiseptics, Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas. Test method and requirements without mechanical action (phase 2, step 2): https://knowledge.bsigroup.com/products/chemical-disinfectants-and-antisepticsquantitative- non-porous-surface-test-for-the-evaluation-of-bactericidal-and-yeasticidaland- or-fungicidal-activity-of-chemical-disinfectants-used-in-food-industrial-domesticand- institutional-areas?version=tracked
- USP <1072> Disinfectants and Antiseptics, United States Pharmacopeia, 2013: https://online.uspnf.com/uspnf/document/1_GUID-8DF22C37-97ED-452D-AF5B- 52BF4975FA22_1_en-US
- Cleanroom Technology Article ‘Call for a global disinfectant standard’ November 2019. https://cleanroomtechnology.com/news/article_page/Call_for_a_global_disinfectant_st andard/159568
- EN 16615:2015 Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test). Test method and requirements (phase 2, step 2), CEN 2015: https://knowledge.bsigroup.com/products/chemical-disinfectants-and-antisepticsquantitative- test-method-for-the-evaluation-of-bactericidal-and-yeasticidal-activity-onnon- porous-surfaces-with-mechanical-action-employing-wipes-in-the-medical-area-4- field-test-test-method-and?version=standard
- ECHA Technical Agreement for Biocides v2.2 https://echa.europa.eu/guidancedocuments/ guidance-on-biocides-legislation