Class 100 Cleanroom Design and Implementation | ISO & GMP Standards

Class 100 cleanrooms (ISO 5) are high-performance controlled environments designed to maintain extremely low particle counts. They are widely used in semiconductor manufacturing, pharmaceutical production, biotechnology, aerospace, optics, and other industries requiring ultra-clean conditions. Farclean specializes in the design, construction, and commissioning of Class 100 cleanrooms that comply with ISO 14644-1 and GMP standards.

Key Considerations in Class 100 Cleanroom Design

• Airflow design: Unidirectional laminar airflow (vertical or horizontal) to ensure particles are removed efficiently.
• HEPA/ULPA filtration: H13/H14 or ULPA filters to maintain ISO 5 cleanliness.
• Pressure control: Maintain positive pressure relative to surrounding areas to prevent contamination ingress.
• Surface finishes: Smooth, non-shedding, chemical-resistant walls, ceilings, and floors.
• Environmental monitoring: Temperature, humidity, differential pressure, and particle counts to ensure compliance.
• Modular layout: Flexible design for easy maintenance and future expansion.

Components of a Class 100 Cleanroom

• Wall and ceiling panels: Sandwich panels with fire-resistant and easy-to-clean surfaces.
• Flooring: ESD-safe vinyl, epoxy, or raised access flooring for utilities.
• HVAC system: High-efficiency airflow with laminar flow diffusers and recirculation units.
• Cleanroom doors and pass-throughs: Air-tight with smooth surfaces for hygiene and pressure maintenance.
• Lighting: Flush-mounted, dustproof, and cleanroom-compatible illumination.
• Air showers: Optional personnel entry systems to reduce contamination transfer.
• Monitoring and control systems: Automated sensors for airflow, particle counts, and environmental parameters.

Design & Implementation Process

1. Requirement Analysis: Define cleanroom class, layout, workflow, and regulatory requirements.
2. Conceptual Design: Prepare floor plans, airflow diagrams, and equipment placement.
3. Detailed Engineering: Structural, electrical, HVAC, and plumbing integration with modular panels and systems.
4. Construction & Installation: Modular wall panels, ceilings, floors, doors, HEPA units, and HVAC components.
5. Commissioning & Validation: Particle count tests, airflow validation, pressure differential checks, and GMP/ISO documentation.
6. Training & Handover: Staff training, SOPs, and maintenance schedules for long-term compliance.

Benefits of Farclean Class 100 Cleanrooms

• ISO 5 / Class 100 compliant environment for critical operations
• Modular, scalable, and flexible design for future expansion
• Reliable HEPA/ULPA filtration and airflow systems
• Integrated environmental monitoring and validation support
• Optimized layouts for personnel workflow, material handling, and contamination control

Applications

• Semiconductor wafer processing
• Microelectronics assembly
• Pharmaceutical and biotechnology production
• Medical device manufacturing
• Precision optics and aerospace components

Call to Action

Looking to design and implement a Class 100 cleanroom for your facility? Contact Farclean for a consultation, layout design, and turnkey cleanroom solutions.