Airspace Systems, LLC specializes in the design, cleaning, and commissioning of cleanrooms. We are an essential business supplier for medical device, cleanroom, and general manufacturing industries. With years of experience and a commitment to excellence, we ensure that your cleanroom meets the highest standards of cleanliness and functionality.
We provide comprehensive design services to create efficient and compliant cleanrooms tailored to your needs, leveraging ISO and MIL standards and industry best practices to create custom cleanroom solutions tailored to your specific needs. We take into account your unique process requirements, space constraints, and regulatory standards to develop an optimal layout that maximizes efficiency and functionality. From initial concept to detailed engineering and 3D modeling, we provide comprehensive design services to ensure your cleanroom meets the highest standards of performance and reliability.
Our highly trained and certified cleaning technicians follow strict protocols to maintain the integrity of your cleanroom environment. We offer a wide range of cleaning services, including initial cleanroom cleaning, periodic maintenance cleaning, and emergency cleaning to address any unexpected contamination issues. Our cleaning processes are designed to minimize disruption to your operations while ensuring that your cleanroom remains compliant with ISO/MIL standards and industry regulations.
Our team provides comprehensive inspection, testing, verification, and documentation services to ensure that your cleanroom is fully operational and performs to your specified requirements. Typical engagements include inspection, particle count testing, airflow monitoring, and HEPA filter integrity testing, to validate that your cleanroom meets the required cleanliness levels for your specific application. Our commissioning services also include training for your staff on proper cleanroom procedures and maintenance to ensure ongoing compliance and optimal performance.
| ISO 14644-1 | FEDERAL STANDARD 209E | ISO Class | English | Metric |
|---|---|---|---|---|
| ISO 1 | ||||
| ISO 2 | ||||
| ISO 3 | 1 | M1.5 | ||
| ISO 4 | 10 | M2.5 | ||
| ISO 5 | 100 | M3.5 | ||
| ISO 6 | 1,000 | M4.5 | ||
| ISO 7 | 10,000 | M5.5 | ||
| ISO 8 | 100,000 | M6.5 | ||
| ISO 9 |
| CLASS | 0.1 micron | 0.2 micron | 0.3 micron | 0.5 micron | 1 micron | 5 microns |
|---|---|---|---|---|---|---|
| ISO 1 | 10 | 2 | ||||
| ISO 2 | 100 | 24 | 10 | 4 | ||
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| ISO 7 | 352,000 | 83,200 | 2,930 | |||
| ISO 8 | 3,520,000 | 832,000 | 29,300 | |||
| ISO 9 | 35,200,000 | 8,320,000 | 293,000 |
In cleanrooms, particulate concentration changes over time — from the construction and installation of equipment to its operational status. ISO delineates three cleanroom classification standards: as-built, at-rest and operational. As instruments and equipment are introduced and particulates rise, an “as-built” cleanroom becomes an “at-rest” cleanroom. When people are added to the matrix, particulate levels rise still further in the “operational” cleanroom.
| Test Parameter | Class | Maximum Time Interval | Test Procedure |
|---|---|---|---|
| Particle Count Test | <= ISO 5 | 6 Months | ISO 14644-1 Annex A |
| Particle Count Test | > ISO 5 | 12 Months | ISO 14644-1 Annex A |
| Air Pressure Difference | All Classes | 12 Months | ISO 14644-1 Annex B5 |
| Airflow | All Classes | 12 Months | ISO 14644-1 Annex B4 |
| Test Parameter | Class | Maximum Time Interval | Test Procedure |
|---|---|---|---|
| Installed Filter Leakage | All Classes | 24 Months | ISO 14644-1 Annex B6 |
| Containment Leakage | All Classes | 24 Months | ISO 14644-1 Annex B4 |
| Recovery | All Classes | 24 Months | ISO 14644-1 Annex B13 |
| Airflow Visualization | All Classes | 24 Months | ISO 14644-1 Annex B7 |
| ISO Document | Title |
|---|---|
| ISO 14644-1 | Classification of Air Cleanliness |
| ISO 14644-2 | Cleanroom Testing for Compliance |
| ISO 14644-3 | Methods for Evaluating and Measuring Cleanrooms and Associated Controlled Environments |
| ISO 14644-4 | Cleanroom Design and Construction |
| ISO 14644-5 | Cleanroom Operations |
| ISO 14644-6 | Terms, Definitions and Units |
| ISO 14644-7 | Enhanced Clean Devices |
| ISO 14644-8 | Molecular Contamination |
| ISO 14644-9 | Surface Cleanliness by Particle Concentration |
| ISO 14644-10 | Surface Cleanliness by Chemical Concentration |
| ISO 14698-1 | Biocontamination: Control General Principles |
| ISO 14698-2 | Biocontamination: Evaluation and Interpretation of Data |
| ISO 14698-3 | Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces |
Have any questions or need our services? Get in touch with us!
Email: info@airspace.systems
Phone: (510) 828-6586