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¿Qué es la Consultoría en EPC de Sala Limpia? | Su Socio desde el Diseño hasta la Validación
Creado 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
Contacto
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