Cleaning Validation

Error-free and Compliant Cleaning Validation Software for Residue Carryover Limits

From establishing safe carryover limits to performing worst-case evaluations and managing change assessments, CLEEN enables the you to automate your cleaning validation calculations to reduce errors, achieve compliance, and validate with complete confidence as per FDA's cleaning validation guidelines.

Why Leucine ?

Real-Time Validation Status Monitoring

Convert lengthy, complex batch recipes into digital formats within minutes using AI. This efficiency not only saves time but also ensures accuracy, enabling a faster shift to digital operations in your cleaning validation program.

Reduced Risk of Cross-Contamination

Maintaining stringent cleaning validation protocols by rigorously evaluating worst-case scenarios and  minimize the risk of cross-contamination.

Comprehensive Audit Preparedness

Be audit-ready at all times with centralized documentation, making FDA cleaning validation audits smoother and less stressful.

Minimal Downtime Through Efficient Protocol Execution

Reduce downtime by streamlining cleaning validation protocol execution & keep batches running with fewer interruptions, enhancing overall productivity in your facility.

Automate
Limit Calculations

CLEEN automatically calculates cleaning limits using multiple criteria like toxicity and dose-based approaches, reducing manual errors in the cleaning validation process.

Perform Worst Case
Evaluations

Identify the hardest-to-clean molecules in your facility, ensuring thorough cleaning validation in pharma environments.

Audit Ready
Reporting

Make it easy to walk auditors through your cleaning validation program with confidence, adhering to cleaning validation guidelines.

Manage
Facility Changes

Assess the impact of facility changes, such as new products or equipment, on your cleaning validation protocol.

Generate and
Execute Protocols

Create, review, and execute cleaning validation protocols efficiently, streamlining your entire validation process.

Ready to Get Started?

300+ pharma facilities worldwide use Leucine to stay compliant. Talk to one of our expert consultants at Leucine to learn how.

Schedule Demo