Cleaning Validation

Error-free and Compliant, 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.

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.

Reduced Risk of Cross-Contamination

By rigorously evaluating worst-case scenarios and maintaining stringent cleaning protocols.

Comprehensive Audit Preparedness

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

Minimal Downtime Through Efficient Protocol Execution

Reduce downtime by streamlining  protocol execution & keep batches running with fewer interruptions.

Automate
Limit Calculations

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

Perform Worst Case
Evaluations

Identify the hardest-to-clean molecules in your facility

Audit Ready
Reporting

Make it easy to walk auditors through your cleaning validation program with confidence

Manage
Facility Changes

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

Generate and
Execute Protocols

Create, review, and execute validation protocols efficiently.

MES Software ESSENTIALS

Have a look at our other suite of MES Essentials to
10x your process

Batch Manufacturing Executor

Reduce manual data entry, maintain data integrity, ensure compliance and enable intelligent monitoring for streamlined operations

Material Management

Leucine 10x automates CAPA planning, tracking, and verification, enhancing decision-making and preventing recurring quality issues.

Review by Exception

Automate impact assessments, predict and mitigate disruptions, ensure thorough evaluations, and maintain compliance in dynamic environments

Shop Floor Monitor

Explore real-time provides real-time monitoring of equipment and batch processes, optimizing efficiency and ensuring proactive maintenance.

Logbooks

Reduce manual data entry, maintain data integrity, ensure compliance and enable intelligent monitoring for streamlined operations

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