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
Expert Blog
november 10, 2025
Collaboration is the Current Powering a Water-Resilient Future
From the surging power demands of artificial intelligence to the escalating impacts of extreme weather, the Ecolab Water...
august 27, 2025
The Business of Water in the Data Center
As data center demand surges, sustainable strategies must leverage innovative water solutions that support both efficien...
august 20, 2025
Revolutionizing Restaurant Cleanliness With the Drop of a Tablet
Ecolab® ReadyDose™ program, an easy-to-use, tablet-based cleaning program designed to meet the unique needs of global sm...
july 23, 2025
Ecolab’s Role in the AI Boom
Ecolab has cutting-edge solutions and expertise that help data centers reduce water consumption and operate more efficie...
june 12, 2025
AI, Water and the Future of Business: How Ecolab Helps Turn Global Water Challenges Into a Competitive Advantage
Artificial intelligence is transforming the global economy, but it comes with a hidden cost: water. Christophe Beck shar...
january 28, 2025
Water at a Tipping Point How Smart Management Fuels a Thriving Economy
Christophe Beck, Chairman & CEO at Ecolab, shares his thoughts on the essential role smart water management needs to pla...
january 24, 2025
Unlocking Business Opportunities: The Rising Importance of Water at Davos
The discussions at Davos underscored the critical role of water in advancing business growth and resilience and the need...
january 13, 2025
Turning Water Challenges into Opportunities in 2025
With the boom of AI, an escalating water crisis and continued pressure to perform, business leaders must recognize how t...
october 17, 2024
IMPACTful Dialogues: Open Minds, Open Doors for Effective Collaboration
Dexter Davis talks with Tiffany Atwell, executive vice president, Government Relations, about how important openness is ...
july 25, 2024
Campus Cleanliness Matters
The Ecolab Science Certified™ program for Higher Ed is helping universities improve cleanliness, student satisfaction, a...
.jpg&w=3840&q=85&dpl=dpl_Br5J4GxReVn5SmWjHDRNTkcfwpvr)
july 18, 2024
IMPACTful Dialogues: Building Meaningful Relationships with Collaborators
Dexter Davis talks with Adam Johnson, senior vice president, Enterprise Solutions Segment Lead, Food Retail Services, to...
july 17, 2024
Enhancing Our Culture of Inclusion for Caregivers and Associates With Disabilities
Ecolab continues to build support for associates of various abilities and caregivers, earning a top score on the Disabil...