Cleanrooms are designed with HEPA filters and airflow designs to reduce airborne particles. In critical areas, particles will contaminate research or production. Cleanrooms require regular testing and certification to be sure that concentrations of airborne particles are controlled to specific limits.
Rooms are classified by the number of particles per cubic meter per minute. Classifications are described in ISO-14644-1, and they range from ISO class 1 through 9.
Service is generally performed on a quarterly, semi-annual or annual basis. This is determined by current standards, or client applications and requirements.
Our Service Areas:
- New York – NYC, Long Island, Mid-Hudson, Capital & Northern Regions
- New Jersey
- Connecticut
- Massachusetts
- Rhode Island
- Eastern PA
Cleanroom Testing and Certification Services
SEPS offers cleanroom and environmental services, including certification and testing.
All testing is performed by highly qualified technicians in accordance with current good manufacturing practices (cGMP). We follow strict (IEST) Institute of Environmental Sciences and Technology and (ISO) International Organization for Standardization guidelines.
SEPS technicians perform the following tests in all cleanrooms, as our basic (SOP’s) standard operating procedures requires:
- Airflow Volume / Velocity Test
- Room Air Changes per hour test and calculations
- Hepa Filter Integrity Test
- Viables and Non Viable Particle Counting Test
- Pressure Cascade Monitoring
- Temperature / Relative Humidity Test
- Lighting Test
- Sound Test
- Vibration Test (optional)
- Airflow Visualization Test
Immediate Cleanroom Reporting
Cleanroom test reports are offered on the spot. All of our technicians work with SEPS computerized Cert Pro software.
ISO-14644-1 Cleanroom Standards
Particulate concentration will change over time in a cleanroom setting. ISO has three cleanroom timeline classifications: as-built, at-rest, and operational. As you add to your cleanroom with equipment and instruments, the particulates will rise. For instance; an “as-built” clean room will become an “at-rest” cleanroom, once you have added your new equipment to your lab.
How Clean Do You Need Your Cleanroom?
Depending on your industry and activities within the cleanroom, the class will change. SEPS provides consulting services to help meet your specific regulations.
While some industries do not have strict standards, cleanrooms even at an ISO8 will be beneficial. Electronics and optics are often damaged by the airborne dust and debris from unfiltered airflow.
Conversely, industries such as pharmaceutical, will have strict cleanroom needs. Regulatory systems such as the FDA and USP will require specific cleanroom configurations. SEPS will test and certify your cleanrooms, including your enclosure, entry, and main cleanroom.
| Class | Maximum Particles/m3 | |||||
|---|---|---|---|---|---|---|
| 0.1 micron | 0.2 micron | 0.3 micron | 0.5 micron | 1 micron | 5 microns | |
| ISO1 | 10 | 2 | – | – | – | – |
| ISO2 | 100 | 24 | 10 | 4 | – | – |
| ISO3 | 1,000 | 237 | 102 | 35 | 8 | – |
| ISO4 | 10,000 | 2,370 | 1,020 | 352 | 83 | – |
| ISO5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| ISO7 | – | – | – | 352,000 | 83,200 | 2,930 |
| ISO8 | – | – | – | 3,520,000 | 832,000 | 29,300 |
| ISO9 | – | – | – | 35,200,000 | 8,320,000 | 293,000 |