CLEEN is built by experts who’ve lived the challenges of contamination control, compliance and pharma manufacturing – embedding real-world experience into every feature.
Why operational digitization must be the top priority for pharma and biopharma manufacturers.
This free eBook outlines the fundamental shifts associated with embracing Pharma 4.0—and how they can empower organizations to improve efficiency, agility, and maintain product quality while driving business profitability.
Receive in-platform guidance as you build cleaning validations based on continuously updated regulations. Automatically calculate carryover limits and worst-case product rankings, and leverage automated compliance interlocks for CHT/DHT.
Leverage historical data to calculate carryover limits and create protocols in minutes by integrating data from multiple sources, speeding up new product introductions. Receive dynamic alerts for necessary re-validations complete with auto-generated documents for review.
Automatically generate validation reports and store all necessary information in the built-in Audit Portal for immediate access that enables continuous audit-readiness with minimal administrative burden.
Ensure Accurate HBEL-based Residue Limit Calculations
Health-Based Exposure Limits (HBELs) are scientifically derived thresholds that define the maximum acceptable carryover of pharmaceutical residues on shared manufacturing equipment.
New Drug Introduction Risk Assessment
Evaluate the implications of integrating new drugs into current production lines. Instantly determine carryover thresholds, risk levels, and worst-case scenarios. CLEEN’s risk matrix supports cleaning validation, ensures regulatory compliance and enhances operational efficiency.
Auto-Generate Standardized, Compliant Cleaning Validation Protocols
Integrate Residue Data from LIMS to Generate Reports
Track Real-Time Validation Status for all Equipment
Leverage Audit Portal During Inspections
The CLEEN by Ecolab platform seamlessly complements Ecolab’s full portfolio of proven solutions and innovative chemistries across a range of life sciences manufacturing operations.
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CLEEN automates MACO calculations, residue limit assessments, and standardized reporting to align with FDA, EMA and ICH cleaning validation standards. Its audit-ready documentation ensures you’re always inspection-prepared.
Yes. CLEEN is built to integrate seamlessly with your current Quality Management Systems, Laboratory Information Management Systems, and ERPs – eliminating data silos and ensuring a connected validation ecosystem.
CLEEN offers end-to-end automation, real-time tracking, and configurable workflows designed specifically for pharmaceutical industry. It’s built with audit-readiness and regulatory alignment at its core – no generic solutions here.
Absolutely. CLEEN is fully compliant with 21 CFR Part 11, offering secure audit trails, electronic signatures, role-based access control, and data encryption to meet all global data integrity requirements
Customers typically reduce manual validation effort by up to 60%, speed up audit prep by 80%, and reduce compliance risks significantly. CLEEN also saves costs by streamlining documentation and reducing rework.
Implementation time depends on your facility size and system integrations. Most clients are fully operational within 4-8 weeks, with support from our dedicated onboarding and validation teams.
Yes. CLEEN is a secure, cloud-based platform accessible from anywhere, enabling real-time collaboration across global teams while maintaining regulatory compliance.
We do. CLEEN includes hands-on onboarding, live training sessions, detailed documentation, and 24/7 customer support to ensure your team gets up to speed quickly and confidently.
Absolutely. You can request a personalized demo tailored to your facility’s needs. We’ll show how CLEEN fits into your existing workflows and regulatory strategy.
Ecolab Life Sciences
1 Ecolab Place
St. Paul, MN 55102
Please speak to your Ecolab account manager for further information, call +1-800-659-3764.
