AI-powered cleaning validation software automating the entire cleaning lifecycle for pharmaceutical manufacturing. FDA and EMA compliant with automated HBEL calculations, worst-case product selection, and real-time residue trend monitoring.
CLEEN is cleaning validation software designed to automate the cleaning lifecycle end-to-end and support EMA/FDA compliance. The vendor states it is trusted by Fortune 500 pharmaceutical companies and markets it as the "#1 Cleaning Validation Software for Pharma." The platform digitises the cleaning validation lifecycle from design through qualification to monitoring.
Key capabilities include error-free HBEL (Health-Based Exposure Limits) calculations in compliance with evolving regulatory guidelines, auto-generated validation protocols and reports, and centralized cleaning data for consistent audit success. Safe carryover limits are auto-calculated for critical residues including actives, intermediates, cleaning agents, solvents, microbial contamination, and nitrosamines.
Worst-case products are selected based on 20+ user-configurable risk attributes such as solubility, cleanability, risk priority numbers, and other parameters. Protocols are auto-generated for studies including validation, verification, changeovers, and hold-times. Auto-generated sampling sheets with rich images guide effective sampling execution.
The platform integrates residue data from LIMS to generate comprehensive reports. Tracks real-time validation status for all equipment and pulls residue results and key parameters from LIMS to create coherent final validation summaries aligned with FDA expectations. Users report 70% improvement in validation cycle times after 1 year of use.
Pharmaceutical Edition
CLEEN is pharma-specific by design. The product is built for GMP-regulated pharmaceutical and biotech manufacturing environments. Designed for FDA and EMA compliance with automated HBEL-based residue calculations and worst-case product selection. Supports FDA 21 CFR Part 11, FDA Six Systems, and global regulatory standards.
Core Capabilities
FDA & GxP Compliance
Data Integrity & Validation
Cloud-based SaaS platform accessible via web browser. Integrates with ERP systems and LIMS for residue data synchronization. Works with existing pharmaceutical manufacturing technology stacks.
Platform designed for pharmaceutical manufacturing environments with AI-powered automation. Supports real-time data integration and monitoring. Deployment details, API documentation, and technical requirements are undisclosed; the platform works with other systems including ERP and LIMS.
Pricing is undisclosed. Contact Leucine for enterprise quotes; a demo is available through the website.
Ecolab (NYSE: ECL) is a strategic investor. The vendor states CLEEN serves Fortune 500 pharmaceutical companies. 30+ pharmaceutical companies use CLEEN across 300+ facilities.
Users report 70% improvement in validation cycle times after 1 year of use. Implementation support available for deployment across pharmaceutical manufacturing facilities. Platform designed for fast implementation with intuitive interface praised by users.
The platform serves 300+ manufacturing facilities globally. Users highlight fast implementation times and responsive customer support. Specific implementation timelines and migration support details vary by customer requirements.
PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.
Strengths
Users report 70% improvement in validation cycle times after 1 year of use. The platform integrates well with ERP and LIMS systems. Users praise the intuitive interface and fast implementation times, and highlight responsive customer support. Fortune 500 pharmaceutical companies use the platform, per the vendor. Cipla, a major pharmaceutical company, featured CLEEN in its annual report. The vendor describes CLEEN as the "preferred choice of regulators," bringing accuracy, consistency, and harmonisation to cleaning procedures.
Limitations & Open Questions
Review content on major platforms including Capterra and G2 is limited, which makes independent assessment challenging. Leucine was founded in 2015 and has raised Series A funding. The only publicly named customer is Cipla, in India; the vendor describes global expansion as ongoing.
Help the community
Share your experience with Leucine CLEEN anonymously. Your insights help pharmaceutical professionals make better software decisions.
Contribute Anonymous FeedbackPublicly disclosed pharmaceutical and biotech organizations
Jump to section