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Challenges in Efficacy Validation
Disinfectant efficacy testing can be a daunting task as there are numerous factors to consider:
효능
Existing supplier efficacy methods and data not specific to the cleanroom environment
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
시간
6-12+ Months
typical validation timeline
비용
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 facility1”
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 material2”
- 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
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.
Article:
Validex™: A Comprehensive Data Package for Wipes Efficacy Evaluation
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.
전문성
- 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