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Achieving ISO Class 10,000 Cleanroom Standards

  • 2024-02-01
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ISO Class 10,000 is an air cleanliness classification defined by the maximum allowable concentration of airborne particles. Meeting ISO Class 10,000 specifications necessitates careful cleanroom design equipment selection and operating procedures.


Achieving ISO Class 10,000 Cleanroom Standards


Allowable Particulate Concentrations

No more than 10 particles ≥ 5 μm per liter

No more than 100 particles ≥ 0.5 μm per liter

No more than 1,000 particles ≥ 0.1 μm per liter

Typical Applications Requiring Class 10,000

Many manufacturing processes for electronics, optics, pharmaceuticals, and medical devices need to operate in ISO Class 10,000 environments.


Critical Cleanroom Design Aspects

Achieving ISO 10,000 standards requires attention in:


Air Filtration and Ventilation

HEPA filter fan units provide laminar airflow. Minimum 15 air changes per hour.


Architectural Finishes and Materials

Non-particle shedding surfaces like vinyl floors, epoxy paints, and fiberglass wall systems.


Environmental Controls

Humidity, temperature and pressurization parameters must adhere to specifications.


Utility Infrastructure

Services like pure water, compressed air, vacuum and power conditioning with backup systems.


Key Cleanroom Equipment for Class 10,000

Critical equipment includes:


HEPA Fan Filter Units

Provide laminar airflow and maintain air purity.


Air Showers and Gowning Rooms

Personnel airlocks limit particulate infiltration.


Cleanroom Furniture and Carts

Stainless steel designs prevent particles.


Particle Monitoring Systems

Remote particle counters with limit alarms ensure compliance.


Operational Protocols and Procedures

Strict protocols are required:


Personnel Gowning Requirements

Appropriate garments, gloves, boots, hoods based on specifications.


Routine Cleaning and Disinfection

Scheduled surface wiping, mopping, vacuuming and disinfecting.


Airflow Verification and Testing

Daily verification of proper airflow patterns and velocities.


Certification and Re-certification

Full particulate count testing every 6 months at minimum.


Benefits of a Class 10,000 Space

Benefits include:


Control of Particulates

Preventing defects and contamination from airborne particles.


Reduced Defects and Rejects

Maintaining cleanliness improves manufacturing yields.


Improved Production Efficiency

Less rework and disruptions from contamination events.


Challenges with Class 10,000 Cleanrooms

However, significant challenges exist:


Substantial Facility Investments

Installing the specialized infrastructure is capital intensive.


Rigorous Procedures and Training

Program development and training on proper cleanroom operations.


Ongoing Operating Expenses

HEPA filters, garment laundry/replacement, utilities and certification amount to high costs.


Conclusion

The stringent particulate concentration requirements of ISO Class 10,000 cleanrooms demand significant investments in cleanroom infrastructure, equipment, protocols and staff training. But the improved quality and efficiency gains make meeting 10,000 standards worthwhile for manufacturers of precision technologies and healthcare products. Working with a qualified cleanroom designer is key for proper planning and execution.


FAQs

Q: How often should cleanroom garments be replaced in a Class 10,000 space?

A: Daily replacing of gowns, suits, hoods, gloves and masks is recommended for Class 10,000 environments.


Q: Are portable particle counters acceptable for ISO 10,000 testing?

A: Yes, provided they are properly calibrated. Fixed continuous particle counters with alerts offer optimal monitoring.


Q: What materials are prohibited in a 10,000 cleanroom?

A: Any particulate generating materials like synthetics, paper, cardboard, wood, powders, etc. Stainless steel, glass and epoxy painted surfaces are preferred.


Q: Can a Class 10,000 cleanroom use a recirculated air system?

A: Yes, provided HEPA filters are installed to maintain air purity. 100% fresh air systems can also be used.


Q: How often should filters be changed out?

A: Most filter manufacturers recommend replacing HEPA filters once pressure drop exceeds 1.0” of water to maintain performance.


Kwang Cleanroom is proud to offer examples of a variety of our cleanroom projects below.  Clean Room Development,  ISO 5 Clean RoomCleanroom ISO Class StandardsCleanroom DevicesClean Room SolutionsBiopharmaceutical CleanroomCleanroom Design and Build.

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