Kiểm tra rò rỉ HEPA và phân loại phòng sạch khác nhau ở mục tiêu, thiết bị và hồ sơ nào?

Kiểm tra rò rỉ HEPA và phân loại phòng sạch khác nhau ở mục tiêu, thiết bị và hồ sơ nào?

HEPA rò rỉ kiểm tra đạt có nghĩa phòng đạt ISO Class không?

Phân loại độ sạch cao có chứng minh HEPA rò không?

Máy đếm hạt có dùng scan HEPA được không?

Repair HEPA xong có cần kiểm tra lại không?

Cần xác định đúng phạm vi HEPA kiểm tra và phân loại độ sạch?

The tests answer different questions

An installed filter system leakage test looks for local penetration or bypass at the filter medium, frame, gasket, seal or housing. Cleanroom classification determines whether airborne particle concentration in a room or clean zone meets the specified ISO class under defined conditions.

A room may meet classification at selected locations while a local defect remains undetected without scanning. A filter system may pass leakage testing while the room fails classification because of airflow, cleaning, people, equipment or another particle source.

Leak testing requires a controlled challenge and scan

ISO 14644-3 includes installed filter system leakage testing among cleanroom performance methods. A suitable upstream aerosol challenge must reach the filter in a controlled and representative manner. Probe distance, scanning speed, overlap, response time and coverage of the filter face, frame and seals affect detection capability.

The report should identify filter, challenge, upstream measurement, scan route, detected leak, repair and retest. A negative result is not meaningful if the challenge was unstable or the scan did not cover the installed system.

Classification uses a particle sampling plan

ISO 14644-1 classifies air cleanliness by particle concentration. The protocol defines ISO class, particle sizes, at-rest or in-operation state, number of locations, sample volume and measurement conditions. The airborne particle counter must be suitable and calibrated for the application.

Lasair Pro is positioned by PMS for cleanroom certification and monitoring. The selected model and flow rate should match class, volume and available sampling time. Classification data do not independently identify a HEPA leak.

Keep separate records and connect the conclusions

Qualification can include both tests, but each needs its own objective, method, equipment, acceptance criteria and report. Filter identifiers should connect scan results, repairs and retests to room location. Classification records should connect sampling locations, state, counts and final class decision.

An abnormal classification point may trigger filter scanning, airflow visualization, cleaning review or source investigation. The conclusion should come from the appropriate follow-up test rather than assumption.

Authorized application support

SAO NAM is the Authorized Sales and Service Center for Particle Measuring Systems specializing in Life Science in Vietnam. Support may include selection of suitable PMS particle-counting equipment, configuration, official supply, training, calibration, maintenance and technical application review according to project scope. The site and qualified testing organization retain responsibility for approved protocols, aerosol safety, acceptance criteria and facility release.

Implementation and review controls

Test sequencing and room condition should be defined before qualification begins. Filter installation, HVAC balancing, cleaning and recovery can affect the appropriate order of leakage testing and classification. The protocol should prevent a passing classification result from being used to waive a required integrity test, or a passing filter scan from being used to release a room without concentration data. When a result is abnormal, retain the scan map, sampling layout, room state, upstream challenge data, instrument certificates and repair history. Linking these records supports a defensible investigation and shows whether the issue was local filter penetration, bypass, airflow behavior, contamination from operations or a measurement problem.