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Cleaning Validation, Simplified.
CLEEN is built by experts who’ve lived the challenges of contamination control, compliance and pharma manufacturing – embedding real-world experience into every feature.
CLEEN Pillers
Empowering cleaning compliance from start to shine — the CLEEN platform supports every step of your validation journey.
Bewertung
Conduct risk-based assessments for cleaning validation, including product risk assessment and change impact assessment.
Utilize risk-based methodologies to select worst-case products and establish residue limits for various contaminants.
Prozesseffizienz
Build, review, and approve protocols for validation and verification studies, including visual, residual, and microbial verification.
Auto-generate lifecycle documents such as protocols, inspections, and reports.
Plan and track validation studies, verification studies, and changeover studies using a unified Cleaning Validation Program (CVP) calendar.
Audit Readiness
CLEEN provides a built-in audit portal for generating standard one-click reports for frequent data presentations during audits.
The platform ensures that cleaning procedures are performed correctly with intelligent job summary reports and step-by-step work instruction.
Digitalisieren Sie Ihre Reinigungsvalidierungsstrategie mit CLEEN
Digitize your cleaning validation to eliminate the time needed to prepare for an audit and to have all the answers ready to back up your strategy.
CLEEN Cleaning Validation Module Sell Sheet
Elevate your pharmaceutical manufacturing with next generation cleaning validation management.
Risk-Based Cleaning Validation Check List
Is Your Cleaning Validation Process Truly Risk-Aligned? Find out now with this quick, actionable checklist designed to protect product integrity and compliance.
Reduce the Time for New Drug Risk Assessment from 1-2 Weeks to < 1 Day
Built-in risk assessment assists users in evaluating multiple inputs. It also compares health-based exposure limits (HBEL) with historical residue data and identify the extent of validation requirements.
Modernisieren Sie die Reinigungsvalidierung mit intelligenter Automatisierung
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Gewährleistung konformer Validierungen
Profitieren Sie von plattforminternen Anweisungen zur Erstellung von Validierungen von Reinigungsabläufen auf der Grundlage ständig aktualisierter Vorschriften. Berechnen Sie automatisch Verschleppungsgrenzen sowie Worst-Case-Produktklassifizierungen und nutzen Sie automatische Compliance-Sperren für CHT/DHT.
Beschleunigte Re-Validierung
Nutzen Sie historische Daten, um Verschleppungsgrenzen zu berechnen und Protokolle in wenigen Minuten zu erstellen, indem Sie Daten aus mehreren Quellen integrieren, um die Einführung neuer Produkte zu beschleunigen. Erhalten Sie dynamische Benachrichtigungen für notwendige erneute Validierungen mit automatisch generierten Dokumenten zur Überprüfung.
Vereinfachung der Bereitschaft für Audits
Erstellen Sie Validierungsberichte automatisch und speichern Sie alle erforderlichen Informationen im integrierten Audit-Portal für den unmittelbaren Zugriff, der eine kontinuierliche Bereitschaft für Audits bei minimalem Verwaltungsaufwand ermöglicht.
Hauptmerkmale
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.
- Calculate safe residue limits automatically using HBEL data to ensure worst-case MACO (maximum allowable carryover) compliance.
- CLEEN supports risk-based cleaning validation in pharma aligned with FDA and ICH expectation.
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.
- Instant impact analysis to assess cross-contamination risks in shared facilities.
- Analytical method validation, especially around Limit of Detection (LOD).
- Forecasting future risks and updating cleaning validation parameters.
Auto-Generate Standardized, Compliant Cleaning Validation Protocols
- Auto-generates protocols using built-in risk assessments, HBEL data and historical residue profiles.
- Supports carryover limit calculations for actives, detergents, microbials and nitrosamines.
- Enables one-click protocol creation by aggregating risk assessments, analytical methods and toxicity data.
- Provides real-time alerts when new validations are required, ensuring compliance continuity.
Integrate Residue Data from LIMS to Generate Reports
- Imports residue results from LIMS directly into the validation platform.
- Generates comprehensive reports using pre-configured templates.
- Supports automated protocol generation, residue limit calculations and real-time validation tracking.
Track Real-Time Validation Status for all Equipment
- Tracks real-time validation status across all equipment.
- Visually distinguishes between completed, ongoing and pending validations.
- Integrates with scheduling tools to manage multiple studies simultaneously.
- Supports customizable reports for FDA.
Leverage Audit Portal During Inspections
- Immediate access to validation reports, SOPs, protocols and supporting documents.
- Digitally-signed, Part 11-compliant logs for traceability and regulatory alignment.
- Maintain a complete audit trail of changes, validations and operator actions.
- Allows external auditors to securely access relevant data without exposing unrelated systems.
- Regulatory Inspections: Pull up product-specific reports for a 360° view of cleaning performance.
Häufig gestellte Fragen
Konforme und skalierbare Cloud-Infrastruktur
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.
CLEEN allows you to assess risks based on product toxicity, solubility, batch size, and more, helping to prevent cross contamination. It calculates worst-case scenarios automatically and supports ICH and APIC cleaning validation frameworks.
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.
Erfahren Sie, wie Valent BioSciences mit CLEEN die manuelle Führung von Aufzeichnungen in datengesteuerte betriebliche Effizienz umgewandelt hat.
Ecolab beliefert Valent BioSciences seit fast einem Jahrzehnt mit chemischen Lösungen, und diese vertrauensvolle Partnerschaft spiegelt sich auch in der Erfahrung von Valent BioSciences mit der CLEEN-Plattform wider.
Pharma 4.0
Warum die betriebliche Digitalisierung für Pharma- und Biopharma-Hersteller oberste Priorität haben muss.
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.
Vermeidung der wichtigsten Beanstandungen in FDA-Formular 483 bei der pharmazeutischen Herstellung
Warum proaktive Maßnahmen für Pharmahersteller oberste Priorität haben sollten.
Dieser umfassende Artikel beschreibt die wichtigsten Beobachtungen zu vermeidbaren Problemen in der pharmazeutischen Produktion. Es werden proaktive Maßnahmen zur Verbesserung der Konformität erläutert, um die Produktqualität sicherzustellen und die Einhaltung gesetzlicher Vorschriften zu gewährleisten, während gleichzeitig die betriebliche Effizienz optimiert wird.