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Cleaning Validation

CLEEN: E2E Cleaning Validation Software for effortless compliance

Make you cleaning validation standard, risk-based & harmonized
Health Based Exposure Limits Limits & Worst Cases

Error-free HBEL in compliance with evolving regulatory guidelines

Safe Carryover Limits are auto-calculated for critical residues such as Actives, Intermediates, Cleaning Agents, Solvents, Microbial, Nitrosamines and more. The safe carryover levels get auto-calibrated as well based on changes in the facility master data.
Worst case products are selected based on user-configurable risk attributes such as solubility, cleanability, risk priority numbers, and 20+ other parameters.
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Cleaning Validation Protocol & Report

Auto-generated Validation Protocols & Reports

Protocols are auto-generated for studies such as Validation, Verification, Changeovers, Hold-times, and more. Auto-generated sampling sheets with rich images can be used to carry out sampling effectively.
Validation Reports are auto-compiled using the results of visual inspections and analytical sampling using specific and non-specific methods such as TOC, pH, Conductivity, etc.
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Cleaning Process Effectiveness

All cleaning data in one place, present during audits for consistent success

Built-in Audit Portal is used to present reports & data during regulatory audits. Reports provide a holistic view of the critical aspects of Cleaning Validation such as HBEL Risk Assessments, Residue Trends, Analytical Method health, and more.
Product-specific reports are useful to analyze the 360-degree performance of a cleaning procedure for a given product. CDMOs can present these reports during Customer Audits for their products.
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