Designing an Effective Cleaning Validation Program
Risk-based limits, visual residue identification, and digital process verification — with experts from Ecolab and Leucine.
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About the Webinar
Thomas Altman (Ecolab) and Vivek Gera (Leucine) cover three pillars of modern cleaning validation: HBEL-based limit setting, visual residue identification, and ongoing process verification.
The session explains why dose-based limits are giving way to HBEL-driven maximum safe carryover values, how to set operational limits below the HBEL, and how digital tracking of cleaning process parameters can reduce routine sampling by up to 80%.
Key Themes
- ↪ Setting operational limits below the HBEL — not at the threshold
- ↪ Visual residue identification with operator training and EMA Q&A compliance
- ↪ Digital tracking of flow rate, pressure, and temperature during cleaning
- ↪ Risk-based sampling reduction using process capability scores
80%
Less Routine Sampling
HBEL
Risk-Based Limit Setting
CPP
Process Parameter Tracking
EMA + FDA
Regulatory Aligned
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Meet the
Speakers
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Leucine CLEEN
The cleaning validation platform that automates HBEL-based residue calculations, worst-case matrix generation, and protocol auto-generation — reducing validation cycle times by up to 80% while maintaining 21 CFR Part 11 compliance.
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Key Takeaways
Set operational limits well below the HBEL — leave room to detect trends and act before reaching the regulatory threshold.
Dose-based limits are being replaced by HBEL approaches aligned with EMA Annex 15 and ISPE guidance.
Visual residue limits must be identified through systematic studies — the EMA Q&A requires operator eyesight testing.
Digitally tracking cleaning parameters (flow, pressure, temperature) turns cleaning from a black box into a data-driven process.
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Interested in what Leucine demonstrated at Designing an Effective Cleaning Validation Program? Our team can walk you through the platform and discuss how it applies to your manufacturing operations.