Existing supplier efficacy methods and data not specific to the cleanroom environment
Validex™ Program
Methodology, data and expertise to ease the disinfectant validation process. Now including the assessment of surface wipes.
Challenges in Efficacy Validation
Disinfectant efficacy testing can be a daunting task as there are numerous factors to consider:
Efficacy
Compliance
Regulations provide guidance, but do not tell you what to do or how to do it
Inconsistency
Sites use different validation test methods because there is no global standard
Time
6-12+ Months
typical validation timeline
Cost
Up to $100K
validation costs per facility
Inspection
Variations between regulations and inspectors
Validation is a Regulatory Requirement
The FDA Aseptic Processing Guidance for Industry Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice September 2004 states:
“Routinely used disinfectants should be effective against the normal microbial vegetative flora recovered from the manufacturing facility”
(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)
In addition, EudraLex Vol 4. Annex 1 4.34 states:
“The disinfection process should be validated. Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner in which they are used and on the type of surface material”
(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)
What is the Validex Program?
Ecolab's Validex program was developed specifically for the pharmaceutical industry and provides a clear and reproducible test method for the evaluation of products for use in cleanrooms. First developed in 2018, Validex has been successfully implemented across a wide variety of life sciences sectors. The data independent validation package has now been further developed to include the assessment of wipes.
Related Article
Validex: A Comprehensive Data Package for Wipes Efficacy Evaluation
Validex: A Comprehensive Data Package for Wipes Efficacy Evaluation
Update: Disinfectant Wipe Assessment
The Validex Method
The Validex method has been independently validated through accredited testing laboratories and now includes a combination of both non-mechanical action and mechanical action (wiping) studies, aligning with the Annex1 update that states wipes should be validated in the specific manner in which they are used. The Validex™ wiping method incorporates best practice application technique for the cleanroom (unidirectional overlapping wiping).
The program is designed to ensure an appropriate method and acceptance criteria for the industry that can be used globally. The method has been used to develop a comprehensive data set using a range of relevant cleanroom microflora and surfaces.
Methodology
- Aligned to pharmaceutical manufacturer and regulator expectations
- Method independently validated through accredited testing laboratories
Data
- Data set demonstrates the efficacy of the Ecolab Klercide™ product range across microorganisms and surfaces relevant to the cleanroom environment.
Expertise
- Developed by an Ecolab team and independent laboratory with deep expertise in microbiology, global regulatory standards and validation processes.
The Validex Program gives pharmaceutical manufacturers specific guidance around cleanroom disinfectant validation processes, and enables them to use the data as an extension of their own efficacy studies.
The program can significantly reduce the burden of validation and help to deliver critical outcomes:
Consistency.
Drive consistency across sites with a globally relevant method.
Efficiency.
Reduce the time and costs of validation.
Compliance.
Provide a method and data that aligns with global regulatory criteria.
Expert Validation Support
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 complete our enquiry form or contact your local Ecolab Account Manager for further information on this program.
Watch the Videos Below to Learn More About the Validex Program from Our GTC Team
Watch Now:
Disinfectant Efficacy Validation
Helen Gates, Strategic Technical Consultant Lead, Ecolab
Watch Now:
Why Does My Disinfectant Efficacy Validation Fail?
Matt Cokely, Senior Global Technical Consultant Manager, Ecolab
Get in Touch with Us
Give Us a Call
With unparalleled expertise and cutting-edge technology, we partner with customers to deliver world-class results and optimized operations. Contact us to learn how we can help you.
Ecolab Inc.
1 Ecolab Place
St. Paul, MN 55102
Ecolab Customer Service:
Phone: +1-800-352-5326
Nalco Water Customer Service
Phone: +1-800-288-0879
Give Us a Call
With unparalleled expertise and cutting-edge technology, we partner with customers to deliver world-class results and optimized operations. Contact us to learn how we can help you.
Ecolab Inc.
1 Ecolab Place
St. Paul, MN 55102
Ecolab Customer Service
Phone: +1-800-352-5326
Nalco Water Customer Service
Phone: +1-800-288-0879
Contact Us
Contact Us
* indicates required field