CLEEN
Cleaning validation software
built for FDA inspections
Replace spreadsheet cleaning limits with HBEL-driven calculations and audit-ready validation.
CLEEN
Cleaning validation.
Connected, traced, audit-ready.
Not anymore.
The problem
Cleaning validation
still lives in spreadsheets.
Cleaning validation has been a Top 5 FDA inspection risk since 2018. When limits are hand-calculated and tracked across disconnected files, the gaps surface at the worst possible time.
Root cause
Limits no one can trace
MACO and HBEL calculations sit in unversioned spreadsheets, with no clean path from the toxicological source to the swab limit an inspector asks about.
Root cause
Worst-case goes stale
A new product enters the site and the matrix is not re-evaluated, so validation coverage quietly lapses without anyone noticing.
The cost
You find out at the inspection
Broken calculation trails and missed revalidations surface as 483 observations, the slowest and most expensive place to find them.
Proven at Scale
Running in production at 400+ GMP facilities
New Jersey, USA
Automated HBEL-based cleaning validation with risk-based protocol generation, ensuring continuous FDA and EMA compliance.
Featured in
Annual
Report
Named by brand in a published investor document
We are implementing an intelligent cleaning validation software, CLEEN, to digitise the cleaning validation process. This system assists in decision making at every step with intelligent algorithms, thus eliminating human errors. The system has helped improve our risk analysis and risk evaluation capabilities, leading to better compliance and control.
Capabilities
Every module, purpose-built for cleaning validation.
CLEEN digitises the entire cleaning validation lifecycle into one connected workspace, from limit configuration and change assessment to protocol execution and audit reports. Built-in best practices for USFDA, EMA, MHRA, WHO, and PIC/S.
One connected workspace, defensible from protocol to report.
Protocol design, residue calculations, risk assessments, hold time studies, swab and rinse sampling, and regulatory reporting, with real-time visibility, automated compliance, and audit-ready documentation built in.
CLEEN Cleaning Validation Modules
Protocol Builder — Cleaning Validation Protocol Design
Design cleaning validation protocols with AI-assisted worst-case selection and automated acceptance criteria, so every protocol is defensible before the first swab is taken.
AI-Assisted Worst-Case Selection.
Automatically identifies worst-case products based on toxicity, solubility, and cleaning difficulty. No manual matrix juggling.
Automated Acceptance Criteria.
Calculates MACO, PDE-based, and visual limits from your product data, with full regulatory traceability to FDA and EMA guidance.
Risk-Based Sampling Plans.
Generates sampling point strategies based on equipment complexity, product contact area, and historical cleaning data.
Residue Tracking — Residue Limit Tracking & MACO Calculations
Real-time visibility into residue levels across every piece of equipment, with automated limit comparison, trend analysis, and instant alerts when results drift.
Real-Time Results Dashboard.
Swab and rinse sample results flow in as they're recorded. No waiting for batch compilation to see where you stand.
Automated Limit Comparison.
Every result is instantly compared against acceptance limits with automatic pass/fail determination and deviation triggering.
Historical Trend Analysis.
Track residue trends over time to catch drift early, justify continued process verification, and support lifecycle management.
Risk Assessment — Risk-Based Cleaning Validation Assessment
Structured, ICH Q9-aligned risk assessments that combine toxicity data, equipment complexity, and historical outcomes into defensible, audit-ready risk evaluations.
Toxicity-Based Risk Scoring.
PDE and ADE values integrated directly into risk calculations, linking cleaning limits to patient safety data.
Product Grouping Matrices.
Bracket products by shared characteristics to reduce validation scope while maintaining scientific justification.
AI-Recommended Mitigations.
Historical cleaning outcomes inform suggested risk mitigation strategies, learning from your own data.
Validation Status Tracking — Real-Time Cleaning Validation Status Tracking
Real-time validation status for every piece of equipment across the site, so you always know what is validated, what is pending, and what is at risk, without chasing spreadsheets before an inspection.
Live Equipment Status.
Every equipment's validation state (validated, due, overdue, or in progress) updated as protocols execute, not at month-end.
Site-Wide Coverage View.
See validation coverage across all products and equipment trains in one dashboard, with gaps surfaced before they become observations.
Expiry & Revalidation Alerts.
Automated alerts when validations approach expiry or when changes trigger revalidation. No missed deadlines.
Inspection-Ready Snapshots.
Pull the current validation status of any equipment or product on demand, with full traceability to underlying protocols and results.
Use cases
Every critical cleaning validation moment, covered.
From introducing a new API to pulling an inspector-ready audit package, each scenario runs on the same health-based, connected data model.
Impact studies
What our customers achieved.
What changed when manual cleaning validation became a single, health-based, audit-ready system.
Zydus Lifesciences
"CLEEN transformed how we approach cleaning validation — what used to take weeks of manual calculations and paper-based protocols now runs in hours with full audit-readiness built in. Rolling it out across seven facilities was the proof that this scales."
Manufacturing facilities running CLEEN across India and the US
Faster cleaning validation cycle times through automation
Elimination of manual calculation errors in residue limit computations
FAQ
Frequently asked questions
What is CLEEN?
CLEEN is cleaning validation software for pharmaceutical manufacturing, built by Leucine. It digitises the full cleaning validation lifecycle: health-based (HBEL and PDE) limit calculations, automated worst-case product selection, residue tracking, risk assessments, hold time studies, and audit-ready reporting, on a single 21 CFR Part 11 compliant platform. Zydus runs CLEEN across 7+ facilities with 80% faster validation cycles and zero manual calculation errors.
What does CLEEN's Audit Portal include?
CLEEN's Audit Portal provides one-click export of complete audit packages — protocols, execution data, residue results, risk assessments, and approval records — pre-formatted for FDA, EMA, and WHO expectations. It includes a cross-reference engine that links every record to its source, continuous real-time indexing, and auditor-friendly navigation by equipment, product, or time period.
Is CLEEN compliant with 21 CFR Part 11?
Yes. CLEEN includes full electronic signature trails, tamper-evident audit logs, and role-based access controls on every document and data point — meeting 21 CFR Part 11 requirements for electronic records and signatures.
Can CLEEN handle multi-site cleaning validation programmes?
Yes. CLEEN supports multi-site rollup, aggregating cleaning validation status across all manufacturing sites into a single corporate view — giving quality leadership instant visibility into global programme health.
How does CLEEN calculate MACO and residue limits?
CLEEN automates MACO, PDE-based, and visual limit calculations directly from your product data — no spreadsheets. Every limit traces back to source toxicity data and regulatory guidance (FDA, EMA). Zydus eliminated 100% of manual calculation errors after switching to CLEEN.
How does CLEEN help prepare for FDA inspections?
CLEEN maintains continuous compliance — every protocol, residue result, and risk assessment is validated against FDA expectations as it's created, not retroactively before an inspection. Real-time dashboards flag validation gaps and expiring studies before they become findings, so your team is always audit-ready rather than scrambling to prepare.
How does CLEEN manage dirty and clean hold time studies?
CLEEN provides structured workflows for both dirty and clean hold time studies — from study design through time-point scheduling, automated reminders, statistical analysis, and report generation. Built-in validation establishes defensible time limits with the confidence intervals regulators expect.
Do we need to migrate data from spreadsheets to start using CLEEN?
No. CLEEN replaces spreadsheets and paper logs from day one. Your team configures products, equipment, and cleaning parameters, and CLEEN handles protocol design, limit calculations, residue tracking, and audit documentation going forward. Zydus went from manual processes to 80% faster cleaning validation cycles across 7+ facilities.
How does CLEEN support HBEL-based cleaning validation?
CLEEN makes HBEL-based cleaning validation the default, not an add-on. PDE/ADE values are stored per API, every acceptance limit is derived from health-based exposure limits automatically, and the full calculation trail — from toxicological source to swab limit — is preserved for inspectors. There are no spreadsheet-based calculations left to defend.
Does CLEEN build a risk assessment matrix for cleaning validation?
Yes. CLEEN scores products and equipment on solubility, toxicity, cleanability, and equipment design to build an ICH Q9-aligned risk assessment matrix. The matrix drives protocol scope, sampling plans, and acceptance criteria directly — so the rationale behind every validation decision is documented and defensible.
How does CLEEN handle worst-case product selection in cleaning validation?
CLEEN ranks every product on solubility, toxicity (PDE/ADE), therapeutic dose, and cleaning difficulty to identify worst-case products automatically. When a new product is introduced, the ranking is re-evaluated and CLEEN flags whether existing validation coverage still holds — with a documented rationale for every selection.
Get started
See your cleaning validation run audit-ready.
Book a 30-minute walkthrough on your products and equipment, with no commitment and no sales pitch. We'll show health-based limits, automated worst-case, and live validation status on data like yours.