Cleen

HEALTH BASED EXPOSURE LIMITS LIMITS & WORST CASES

Effortless HBEL Compliance with Updated 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.

CLEANING VALIDATION PROTOCOL & REPORT

Auto-generated Validation Protocols & Reports

Auto-generated protocols for studies such as Validation, Verification, Changeovers, Hold-times, and more.

Auto-generated sampling sheets with rich images for effective sampling.

Auto-compile validation reports with the results of visual inspections and analytical sampling using specific and non-specific methods such as TOC, pH, Conductivity, etc.

Dedicated audit portal for fda audits

Unified Cleaning Data for Seamless Audits

Our Audit Portal can be used to directly 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 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.

Benefits

72%

faster validation report compilation

CLEEN identifies new validations that need to be completed after every change undertaken at the facility

25%

reduction in line clearance time

Easy-to-comprehend SOPs with build in process interlocks make execution faster & seamless

30%

reduction in cost of operations

Automate complex compliance related jobs and operate with lean teams

What do our customers say about us?

"Leucine has been a game changer for us. We absolutely cannot imagine going back to our old way of doing things. We have been able to improve our Product changeover time by 36% and this has helped us manufacture significantly more batches in our facility. Leucine has helped us in not only staying compliant but also in improving our topline

Savannah Nguyen

Customer

Frequently Asked Questions

Is there a free trial available?

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What are the pricing plans and options?

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How can I sign up for Leucine

How is customer support provided?

Streamlined Cleaning Validation for Seamless Compliance

Effortless HBEL Compliance with Updated Guidelines

Auto-generated Validation Protocols & Reports

Unified Cleaning Data for Seamless Audits

What do our customers say about us?

Become a pharma facility of the future with Leucine

Frequently Asked Questions

CAPABILITIES

USE CASES

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CAPABILITIES

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