Guide to Designing a Cleanroom that Meets ISO Class 5 Standards.

An ISO Class 5 cleanroom (or equivalent to Class 100 under FED STD 209E) is a strictly controlled air environment that meets special requirements in high-tech industries. This is one of the highest cleanliness levels, suitable for semiconductor manufacturing, sterile pharmaceuticals, medical devices, and other fields requiring absolute precision.

To design a cleanroom that meets ISO Class 5 standards, factors such as materials, air handling systems, lighting, and technical standards must be optimized. This article provides a detailed guide to cleanroom design and the criteria that must be followed.

1. What Is ISO Class 5?

ISO Class 5 is one of the highest cleanliness classifications specified in the ISO 14644-1 standard, with a strictly controlled cleanliness level:

• Particle concentration:
• ≤ 3,520 particles/m³ (≥ 0.5 micrometers).
• ≤ 29 particles/m³ (≥ 5 micrometers).
• Air change rate:
• 240–600 air changes per hour, depending on the airflow design.
• Common applications:
• Semiconductor component manufacturing.
• Pharmaceutical manufacturing, especially sterile injectable drugs.
• Medical device manufacturing such as surgical instruments and syringes.

2. Design Criteria for an ISO Class 5 Cleanroom

An ISO Class 5 cleanroom must meet the following important design criteria:

2.1. Selection of Construction Materials

Construction materials play an important role in maintaining the cleanliness level inside the room.

• Walls and ceilings:
• Use aluminum panels or electrostatically powder-coated steel panels.
• Surfaces must be smooth, gap-free, dust-resistant, and easy to clean.
• Flooring:
• Use antistatic epoxy flooring or seamless vinyl flooring.
• The floor surface must have good load-bearing capacity, resist cracking, and be easy to clean.
• Doors and windows:
• Use airtight doors with rubber gaskets to prevent air leakage.
• Use double-glazed or tempered glass for insulation and dust resistance.

2.2. HVAC System and Air Control

The HVAC system (Heating, Ventilation, and Air Conditioning) is the foundation of every standard-compliant cleanroom.

• Air filters:
• Use HEPA filters to remove 99.99% of particles ≥ 0.3 micrometers.
• Install filters at both the air supply and return points.
• Airflow:
• Apply unidirectional airflow (laminar flow) or non-unidirectional airflow (turbulent flow) depending on the requirements.
• Airflow velocity ranges from 0.36 to 0.54 m/s.
• Pressure control:
• The cleanroom maintains positive pressure to prevent contaminated air from entering from outside.
• Temperature and humidity control:
• Temperature is maintained at 22±2°C.
• Relative humidity is maintained at 40–60%, depending on production requirements.

2.3. Lighting Design

Lighting in a cleanroom must not only meet illumination requirements but also avoid affecting air quality.

• Lighting type:
• Dust-resistant LED lights that do not emit heat.
• Anti-glare lighting designed to protect the eyes of personnel working in the cleanroom.
• Illumination level:
• Ensure lighting intensity from 500–1000 lux, depending on work requirements.

2.4. Design of Transition Areas (Airlock, Pass Box)

Transition areas are indispensable in an ISO Class 5 cleanroom.

• Air Shower:
• Installed at the cleanroom entrance to remove dust and bacteria from clothing or carried items.
• Airlock door:
• Double doors with an interlock mechanism to ensure that only one door can be opened at a time.
• Pass Box:
• Used to transfer materials in and out of the cleanroom without affecting the cleanliness inside.

2.5. Control and Monitoring System

Modern cleanrooms are integrated with intelligent monitoring systems:

• Sensors:
• Continuously monitor temperature, humidity, pressure, and particle count.
• Control software:
• Automatically adjusts parameters to maintain the optimal environment.
• Alarm system:
• Issues alerts when there are parameter deviations or technical faults.

3. Cleanroom Maintenance and Operation Process

To maintain the long-term effectiveness of an ISO Class 5 cleanroom, proper maintenance and operation are essential.

1. Periodic inspection:
• Replace HEPA filters according to schedule or when performance declines.
• Inspect and clean heat exchangers and the HVAC system.
2. Regular cleaning:
• Use specialized solutions to clean floors, walls, and contact surfaces.
• Ensure that corrosive cleaning agents are not used.
3. Sensor calibration:
• Calibrate measuring devices periodically to ensure accurate data.
4. Staff training:
• Train staff to strictly comply with cleanroom entry and exit procedures.
• Provide specialized protective equipment such as antistatic garments.

4. Benefits of an ISO Class 5 Cleanroom

1. Ensures product quality:
• A clean environment helps minimize defect rates in manufacturing.
2. Compliance with international standards:
• An ISO Class 5 cleanroom meets the requirements of high-end industries.
3. Improves production efficiency:
• Optimal environmental conditions help reduce downtime caused by contamination.
4. Enhances corporate reputation:
• Demonstrates professionalism and production quality, thereby building customer trust.

5. Cleanroom Design and Construction Services at Anh Khang

With many years of experience in the cleanroom industry, Anh Khang provides the following services:

• Cleanroom design: Consulting and implementing optimal solutions for all industries.
• Turnkey construction: Using standard-compliant materials to ensure quality and project progress.
• Maintenance and upgrades: Supporting the performance maintenance and upgrading of existing cleanroom systems.

Contact Anh Khang today for detailed consultation and the best solution for your cleanroom project. For more information, please contact:

ANH KHANG CLEANROOM M&E JOINT STOCK COMPANY Hotline: 1900 636 814 - 0902 051 222 Email: info@akme.com.vn Website: akme.com.vn Address: Lot B7 - Xuan Phuong Garden - Phuong Canh - Nam Tu Liem - Hanoi.