Modular Cleanroom EPC Turnkey Solutions | ISO 14644 & GMP Compliant
Precision pharmaceutical manufacturing demands contamination-free processing environments. Farclean specializes in delivering full modular cleanroom engineering, procurement and construction (EPC) turnkey solutions that meet ISO 14644 and GMP standards. Our integrated facilities guarantee zero particulate intrusion while utilizing high-quality modular wall panels and certified cleanroom doors designed for durability and antimicrobial resistance.
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Comprehensive Class 3-8 Containment Design
Farclean’s modular cleanroom solutions feature precision-engineered systems designed for full compliance with international standards. Our innovative approach integrates FDA cGMP 21 CFR Part 211 requirements with ISO 14644-1 and ISO 14644-4 specifications through:
- Factory-Assembled Wall Systems: Pre-fabricated modular wall panels with fully welded construction achieving superior air containment compared to standard field-erected systems.
- Multi-Seal Door Interface: Advanced cleanroom doors featuring triple sealing gaskets, automatic negative pressure swing doors, and integrated door interlocks to prevent airborne contamination.
- Integrated Air Filtration: HEPA/ULPA filtration integrated directly into wall panel assemblies with precision airflow calculations ensuring uniform velocity profiles.
- Controlled Microclimate: Programmable environmental controls automatically adjusting temperature, humidity, and pressure recovery cycles post-cleaning cycles.
- Certified Material Components: GMP-compliant materials including electropolished 316L stainless steel wall panels and high-density extruded aluminum frames.
Modular Cleanroom Performance Compliance Matrix
| ISO Cleanroom Class | Key Performance Metrics | Farclean Standard Compliance |
|---|---|---|
| ISO Class 3 | <10 CFU/m³ particles, 0.5μm efficiency | Farclean Modular Wall Panels achieve certified <0.1 particles/ft³ for Class 100 equivalents. |
| ISO Class 8 | 10^5 to <10^6 CFU/m³, basic pharmaceutical filtration | Farclean Class 8 specifications include edge-of-wall HEPA integration for compliant dust control. |
| GMP Class A/B | <100 particles ≥5μm, ≤0.5μm particles per ft³ | Farclean cleanroom doors meet EU GMP Annex 1 requirements for critical sterile processing. |
FULL PROJECT VALIDATION & ENGINEERING
Each Farclean modular cleanroom system includes comprehensive documentation for ISO certification and regulatory approval. Our team provides full Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) packages guaranteed to meet client specifications.
