29 Apr Cleanroom Certification

Cleanroom certification is a process that verifies whether a cleanroom meets proper standards, such as ISO or other benchmarks, and is done mainly through testing. Some testing procedures are required for all cleanrooms, and others are only required in certain industries. Certification is done by a third party, but testing is also recommended internally.

1. Classification Standards

The sizes and counts of airborne particles are used to categorize cleanrooms. The primary requirements include:

• ISO 14644-1: This standard classifies air cleanliness levels by measuring particle concentration per cubic meter.
• FED STD 209E: Though this standard has been replaced by ISO, it still remains relevant in some contexts, and measures air particles per cubic foot.

Both of these standards are related as follows:

Industry-specific standards include:

• USP Chapter <797> and <800> for pharmaceutical compounding environments.
• ISO 13485 for medical devices, covering quality management systems.
• ASTM E2352 for aerospace, standardizing cleanroom operations.

2. Testing Procedures

Cleanroom certification often involves:

• Airflow Tests: to check that air movement does not prevent particles from lingering.
• Particle Counts: to ensure particle concentration does not exceed the class limits.
• Air Change Rates: to test for sufficient air turnover/replacement.
• Temperature/Relative Humidity Measurement: to confirm whether HVAC controls are functioning properly.
• HEPA and ULPA Filter Testing: to make sure HEPA/ULPA filters continue to trap the right particle sizes.
• Pressure Differential Testing: to check necessary pressure differences that keep contaminants out (or in).

3. Advanced Testing

Cleanroom certification might also involve:

• Air Balancing and Visualization: to ensure uniform airflow, often using visual tests.
• Environmental Monitoring: to check air and surfaces for biological contamination.
• Compressed Air Testing: to verify that compressed air systems are contaminant-free.

4. Maintenance

Routine testing is important to keep up with cleanroom standards. Third-party evaluations will need to be conducted at least once annually, but internal evaluations can be conducted at least once quarterly.

5. Practical Applications

Manufacturing in industries such as pharmaceuticals, aerospace, and semiconductors depends on strict environmental conditions. Semiconductor manufacturing, for example, cannot tolerate even the slightest particle contamination. Similarly, in aerospace, small particles can cause catastrophic malfunctions in components. As a result, these industries may require stricter-than-usual testing and monitoring.

The Bottom Line

Cleanroom certification is necessary for all cleanroom applications. It helps organizations fight contamination, which in some industries may cause serious issues with products. Standards must continue to keep pace with technological changes to protect economic and scientific outcomes.

Ready to ensure your cleanroom meets the highest standards? Allied Cleanrooms offers customized solutions to fit your needs. Get a free quote today and take the first step towards quality cleanroom performance.