The Validex™ Program by Ecolab provides a methodology, data, and expertise to simplify the disinfectant validation process for the pharmaceutical industry. Developed in 2018 and updated to include surface wipe assessments, this program offers a clear and reproducible test method for evaluating products used in cleanrooms. It addresses challenges such as supplier data specificity, regulatory ambiguity, inconsistent testing methods, long validation timelines (6-12+ months), high costs (up to $100K per facility), and variations in inspection standards. The program's methodology is independently validated through accredited testing laboratories and aligns with global regulatory expectations, including Annex 1 updates for wipe validation. It utilizes a comprehensive data set generated with relevant cleanroom microflora and surfaces, supported by Ecolab's expertise in microbiology, global regulatory standards, and validation processes. The program aims to drive consistency across sites, reduce validation time and costs, and ensure compliance with global regulatory criteria. Ecolab's Global Technical Team offers expert support for designing and executing additional efficacy studies.

Features & Benefits

• Comprehensive Validation Methodology: Includes non-mechanical and mechanical (wiping) action studies, aligned with Annex 1 requirements.
• Data Package for Efficacy: Demonstrates the efficacy of Ecolab's Klercide™ product range against relevant microflora and surfaces.
• Expertise and Support: Developed by a team with deep expertise in microbiology, regulatory standards, and validation processes, offering expert validation support.
• Global Applicability: Provides a globally relevant method and acceptance criteria for consistent application across sites.
• Efficiency and Cost Reduction: Significantly reduces the burden, time, and costs associated with disinfectant validation.