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Qu'est-ce que le conseil en EPC de salle blanche ? | Votre partenaire de la conception à la validation
Créé le 06.25
Defining Cleanroom Consulting
In cleanroom EPC (Engineering, Procurement, Construction), consulting is the critical first phase where experts analyze your requirements, mitigate risks, and design a facility that meets regulatory and operational goals. Unlike generic construction consulting, cleanroom specialists focus on:
Contamination control strategies (airflow, material flows, personnel flows)
Regulatory compliance (FDA, EU GMP, ISO 14644)
Lifecycle cost optimization (energy efficiency, maintenance planning)
Why Cleanroom-Specific Consulting Matters
1. Avoiding Costly Design Errors
Example: A medical device company skipped airflow modeling, resulting in Class 8 zones contaminating Class 7 areas – requiring $500k in post-construction HEPA filter upgrades.
2. Accelerating Regulatory Approval
Our consultants pre-validate designs against:
FDA 483 observation trends (e.g., inadequate pressure cascades) EU Annex 1 (2022) updates for sterile manufacturing
3. Future-Proofing Investments
We prototype modular vs. fixed cleanrooms using CFD analysis, helping clients:
✔ Reduce energy use by 25-40%
✔ Enable easier reconfigurations for new product lines
Our Consulting Methodology
Phase 1: Gap Analysis
Document review: Assess existing SOPs, equipment layouts
Site audit: Identify contamination risks via particle mapping
Phase 2: Design Validation
3D digital twin simulations for:Airflow uniformity (≤15% deviation) Recovery time testing (ISO Class 5 to 5 after door opening)
Phase 3: Vendor Qualification
Pre-vetted supplier shortlists for:Cleanroom panels (leak-tested joints) HVAC with ±1°C temperature control
Recent Project Impact
Client: Vaccine fill-finish facility
Challenge: Achieve EU GMP Annex 1 compliance within 8 months
Our Role:Redesigned unidirectional airflow to meet Grade A/B requirements
Automated pressure monitoring system with 21 CFR Part 11-compliant data logging
Result: Passed EMA inspection with zero critical observations
When to Engage a Cleanroom Consultant
◼ Planning new facilities (>ISO Class 7)
◼ Upgrading legacy cleanrooms to current GMP standards
◼ Expanding into regulated markets (e.g., ATMPs, aseptic processing)
Next Step: Request a Free Cleanroom Readiness Assessment (Includes: Regulatory checklist + ROI comparison template)
Technical Differentiators
Proprietary Tools: Cleanroom Performance Predictor™ software
Standards Leadership: Committee members for ISO 14644 revisions
Global Benchmarking: Data from 300+ cleanrooms across 12 industries
Contact
Laissez vos informations et nous vous contacterons.
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