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Definition of a cleanroom
A Cleanroom is designed to regulate the amount of particles, temperature, humidity, air pressure, and microbes. The semiconductor, medical, biotechnology, and precision manufacturing industries depend on it.
Standard | Particulate matter limit(≥0.5μm/m³) | Application |
ISO 1 | ≤10 | Ultra-high-end semiconductor manufacturing |
ISO 5 (Class 100) | ≤3520 | Pharmaceutical aseptic filling, photolithography |
ISO 7 (Class 10000) | ≤352000 | Electronic assembly, medical device manufacturing |
ISO 8 (Class 100000) | ≤3520000 | Packaging, standard laboratory |
Required attire: Cleanroom coveralls, hood, face mask, nitrile/powder-free gloves, boot covers or dedicated cleanroom shoes
Prohibited attire: Regular clothing, jewellery, watches, cosmetics, and perfume (volatile particles).
1. Gowning Room: Remove outer clothing → Wash hands → Put on clean clothing from top to bottom, avoiding contact with the floor.
2. Air Shower: Stand for 10–15 seconds to allow high-speed airflow to remove surface particles.
3. Entering the Clean Area: Walk slowly and avoid sudden movements (to minimise airflow disturbance).
No running, loud talking, or rapid movement (to prevent dust).
Minimise the number of entries and exits, and avoid frequent opening and closing of doors (to maintain stable pressure differential).
Tools and materials must be wiped or cleaned with an air gun before being brought in.
Clean Bench: Check the status of the HEPA Filter before use, and keep the glass cover closed during operation (ISO 5 grade area).
Vacuum Equipment: Use an oil-free pump to avoid oil contamination.
Daily Cleaning: Wipe down countertops and equipment with IPA (isopropyl alcohol) and lint-free cloths.
Weekly Inspection: Check the pressure difference of the high-efficiency particulate air (HEPA) filter and record PM data.
Particle Leakage: Immediately stop work, notify management, and clean up using a vacuum cleaner (HEPA filter type).
Chemical Leakage: Handle according to the MSDS (Material Safety Data Sheet) and wear splash-proof protective gear.
Abnormal pressure differential: Check if the door is properly closed, or notify the facilities department to adjust the airflow.
Power outage emergency: The cleanroom can maintain positive pressure for approximately 15–30 minutes; sensitive products must be evacuated immediately.
1. Reverse Changing: Remove gloves → head cover → cleanroom suit (roll off from the inside out to avoid contact with contaminated surfaces).
2. Waste Disposal: Dispose of lint-free cloths, gloves, etc. in designated contaminated waste bins.
3. Recording: Complete the Cleanroom Usage Log and record any abnormalities.