The standard for a 100,000-class cleanroom is:

Dust Allowable Count (per cubic meter)

The number of particles larger than or equal to 0.5 micrometers must not exceed 3,500,000, and the number of particles larger than or equal to 5 micrometers must not exceed 20,000.

Microbial Allowable Numbers

The allowable count of free floating bacteria must not exceed 500 per cubic meter.

Colony counts must not exceed 10 per petri dish.

Pressure Difference: Cleanrooms of the same cleanliness grade maintain consistent pressure differences. For adjacent cleanrooms with different cleanliness grades, the pressure difference should be ≥5Pa. The pressure difference between cleanrooms and non-cleanrooms should be ≥10Pa.

When a dust-free workshop of ten thousand square meters has no special requirements for temperature and humidity, it is advisable to wear clean work clothes without discomfort, with the temperature generally controlled at 20-22°C in winter; 24-26°C in summer; with fluctuations of ±2°C. The humidity in the cleanroom is controlled at 30-50% in winter and 50-70% in summer.

Power Distribution: The general illumination value for the main production rooms in dust-free workshops (zones) should be ≥300Lx; for auxiliary studios, personnel and material purification rooms, airlock rooms, corridors, etc., the illumination value should be 200~300Lx.

Noise Control

During dynamic testing, the noise level in the 10,000-class cleanroom should not exceed 70 dB(A).

During static testing, the noise level in a 10,000-class cleanroom with turbulent airflow should not exceed 60 decibels A.

Airflow Organization

The十万级cleanroom mainly employs a supply-air ventilation method.

Local orifice plate ceiling air supply

2. Ceiling air supply with diffuser plate air filters

3. Three types of air supply methods: top wall air supply, etc.

The ten-thousand-class cleanroom mainly utilizes a recirculating air system.

1. Return air outlets are installed at the lower section of the side wall.

2. When employing corridor return air, evenly distribute return air outlets along the corridor or concentrate them at the ends.

Air Outlet Velocity: Meters per Second

Orifice plate orifices 3 to 5.

2. Side supply air outlet

(1) Attachment jet stream 2~5.

(2) Non-adjacent wall lower return air: 1.5~2.5, opposite wall lower return air: 1.0~1.5.

Return Air Velocity (m/s):

The cleanroom return air vent is no larger than 2.

2. The return air vent in the corridor does not exceed 4.

Standard Operating Procedure for 100,000-Class Cleanroom Personnel Entry and Exit

Objective

Establish a Standard Operating Procedure (SOP) for personnel entry and exit in a 100,000-class cleanroom to ensure the cleanroom remains free from contamination.

Scope

The entry and exit of personnel in the 100,000-grade cleanroom of Workshop 10, including production operators, maintenance staff, and management personnel.

3 Responsibility

3.1 All personnel entering or exiting the 100,000-class cleanroom must be responsible for this procedure.

3.2 The Group Leader of the cleanroom and the on-site quality inspector are responsible for supervision and inspection.

4 Content

4.1 Upon entering the cleanroom, place your rain gear and belongings in the designated areas.

4.2 Change your slippers. At the shoe-changing area, sit on the shoe bench, remove your house shoes, and place them in the shoe cabinet. Rotate 180 degrees and put on your slippers from the top shelf of the cabinet.

4.3 Change uniforms. Upon entering the general work area office, remove employee casual attire and put on work uniforms.

4.4 Handwashing. Wash hands according to the handwashing procedure.

4.5 Change work shoes. Upon entering the shoe room, sit on the cross bench facing the door, remove slippers, place them in the lower shelf of the shoe cabinet, take out your work shoes from the upper shelf of the cabinet, and sit down to rotate 180 degrees to put them on, facing the door.

4.6 Wash and dry.

4.6.1 Wet hands with water up to 10 cm above the wrist in the sink, apply detergent, ensuring the skin on hands and 10 cm above the wrist is fully lathered. Rub for about 15 seconds.

Wash hands with water, rinse the rice soak off the hands, flip hands up and down, rub, until no longer slippery.

4.6.3 Inspect hands with the eyes to ensure they are thoroughly clean.

Place your palm 8-10 cm below the hand dryer and dry your hands until completely dry.

4.7 Change into clean undergarments. Remove work clothes and place them in your personal locker. Take off the work hat, jacket, and pants from the wall hooks in the changing room, which are labeled with your personal ID. Put them on in the order from top to bottom: first the hat and mask, then the jacket, and finally the pants. Ensure the top is fully tucked into the pants pockets, all hair is inside the hat, and check that the attire is neat.

4.8 Wash hands, sanitize.

4.8.1 Wet hands with water up to the wrist, apply the cleanser, ensuring the skin on the hands and wrists up to 10 cm is lathered. Rub for approximately 15 seconds.

Wash hands with water, rinse off the soaked rice on the hands, flip and rub the hands up and down until the slippery sensation is no longer felt.

4.8.3 Inspect hands with the eyes to ensure they are thoroughly clean.

Disinfect: Immerse hands up to the wrists in a chlorine-based disinfectant solution for 30 seconds.

On 4.8.5, extend your palm beneath the hand dryer 8-10cm, and dry your hands until completely dry.

4.9 Put on the overall suit. Take out the numbered overall suit from the closet. Put it on from the bottom up, ensuring the suit does not touch the ground.

4.10 Disinfect upon entry. Push the door open into the buffer room, place your hands beneath the automatic sensor dispenser filled with 75% ethanol, spray for disinfection, shake your hands, allowing the ethanol to evaporate.

4.11 Enter the cleanroom. Open the buffer room door and enter the clean area.

4.12 Exiting the cleanroom follows the reverse procedure of entering. Please note to remove protective clothing from the bottom up when taking off your coveralls.

On 4.13, visitors must obtain factory approval to enter the cleanroom under the guidance and supervision of the workshop management, following the prescribed procedures. Visitors are required to strictly adhere to all cleanroom management regulations. During the production period in the cleanroom, visitors are not permitted to enter.