Top 5 Clean Room Testing Standards for High-Precision Industries

High-precision industries such as pharmaceutical and chip manufacturing rely on clean room stability as the determinant of product safety and yield. Most firms invest much in hardware during the design and development stages of the building. But without scientific and systematic Clean Room Testing, even costly equipment and materials will still not get the desired outcome.

This article will explore the key aspects of Clean Room Standards and the essential Clean Room Requirements for project implementation, starting with five core standards.

Why is Clean Room Testing so important?

The core goal of a clean room is to control the number of airborne particles and microorganisms, and to ensure stable environmental indicators such as temperature, humidity, airflow, and pressure differential. Only through scientific clean room testing can we verify that the cleanroom meets design standards and satisfies industry certification requirements such as GMP and ISO.

In the case of the chip manufacturing industry, the presence of a particle as small as 0.1 μm is enough to cause a chip wafer to be declared useless. Airborne microorganisms are directly linked with product compliance and safety in pharmaceutical and cosmetic manufacturing. Food processing factories that overlook clean room testing are at a higher risk of seeing production batches rejected and being unable to access world markets.

Thus, Clean Room Testing is not merely a final procedure before delivery; it is one of the cornerstones of brand and product quality within a company.

Five Clean Room Standards Testing Dimensions

1. Particle Counting and Air Cleanliness Verification

This is the most basic and crucial testing component. Using a professional particle counter, we measure the concentration of particles of varying sizes in the air and align it with ISO 14644-1.

• ISO Class 5-8: Commonly used in industries such as chips and optical components

• ISO Class 7-8: Mostly used in food and cosmetics

• ISO Class 5-6: Common requirements in operating rooms and pharmaceutical production facilities

• Clean Room Requirements are straightforward in this area: The air particle count must be consistently below the specified limit.

2. Airflow Pattern and Air Change Frequency Testing

Clean Rooms have laminar or eddy patterns of the airflow in order to dilute and remove particles. It is possible to test the airflow velocity and the air change frequency to ensure that the standards of the clean room designed were actually put in place.

Semiconductor factories generally require 200-600 air changes per hour. The pharmaceutical industry typically requires 20-40 air changes per hour. Food processing plants may require 15-25 air changes per hour. Scientific clean room testing can help customers avoid hidden dangers caused by dead zones or insufficient air changes.

3. Pressure Differential and Isolation Effectiveness Testing

Appropriate pressure differentials must be maintained between different functional areas to ensure proper air flow to the clean area.

• Clean corridors vs. clean rooms: A pressure differential of ≥10 Pa is generally required.

• Higher-grade areas vs. lower-grade areas: Maintain a stable gradient according to ISO and GMP requirements.

Pressure differential testing is often overlooked, but it is crucial for preventing cross-contamination. For pharmaceutical and cosmetic production, this clean room requirement determines whether the final product will pass relevant regulatory review.

4. Temperature, Humidity, and Comfort Verification

Many customers tend to think that temperature and humidity are simply "personnel comfort issues." In reality, temperature and humidity are directly related to production processes and product quality.

• In the chip industry, excessively high humidity can cause moisture in silicon wafers, while excessively low humidity can easily induce static electricity.

• In the pharmaceutical industry, stable temperature and humidity must be maintained in accordance with GMP requirements.

• In food processing, excessively high humidity can accelerate microbial growth.

Therefore, the temperature and humidity testing included in the Clean Room Standards also ensures the safety of equipment and process flows.

5. Equipment and System Performance Verification

In addition to the clean room environment itself, key purification equipment such as FFUs, AHUs, air showers, and transfer cases must also undergo systematic testing.

• Test filter efficiency (HEPA/ULPA)

• Test air volume and velocity stability

• Test equipment energy efficiency and ongoing performance

These devices are the "heart" of a cleanroom's continued compliance with standards. Their stability determines whether the entire system can meet stringent Clean Room Requirements.

How can we ensure sustainable test results?

Inspection upon delivery alone is not enough. High-precision industries require a long-term clean room testing program, including:

• Regular re-inspections: A full inspection is recommended every 6-12 months.

• Operational monitoring: Sensors monitor particle size, pressure differential, and other indicators in real time.

• Personnel training: To prevent contamination caused by human interaction.

As a one-stop clean room service provider with over 17 years of experience, we not only provide testing and reporting, but also customize long-term maintenance and upgrade plans based on actual processes.

Conclusion

Verification and maintenance of the five Clean Room Standards is a process that requires long-term testing. It is vital not only in order to comply with and obtain certifications, but also to define the quality of the products produced and the competitiveness of the companies as brands.

If you're planning a project in chip manufacturing, pharmaceuticals, cosmetics, or food processing, please contact Design Clean Room.

We offer one-stop solutions, from design and construction to clean room testing, to help you meet the most stringent clean room requirements and maintain your edge in a highly competitive market.