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Cleanroom operation procedure
2026/7/14
Here is the complete and directly implementable standard operating procedure (SOP):
I. Personnel Entry and Exit and Operating Procedures
1) Enter the process (follow the sequence strictly, and it cannot be reversed)
1. One more (Leave the area)
Remove all personal items such as jewelry, watches, mobile phones, keys, etc., and store them in the designated cabinet.
Take off the outer clothes and trousers, leaving only the underwear.
Change into clean slippers and enter the hand-washing and disinfection area.
2. Hand washing and disinfection
Wash your hands with hand sanitizer for at least 20 seconds following the seven-step handwashing procedure.
Dry thoroughly with a hand dryer and do not use regular towels.
Spray 75% alcohol/isopropyl alcohol on the hands and let them air dry naturally.
3. Second Shift (Changing Area)
Wear in sequence: Clean cap (covering the entire head and ears) → Mask (fitting tightly around the mouth and nose) → Clean suit (zippers fully closed, cuffs tightened) → Clean gloves (covering the cuffs) → Clean shoes/foot covers: No exposed skin, no hair, no wrinkles, no damage
4. Air shower / Airlock
Enter the air shower room, close the door → Start the air shower (for at least 15 seconds, rotating 360 degrees)
After the wind shower is completed, open the door and enter the clean area; it is strictly prohibited to open both doors simultaneously.
2. Exit process (reverse operation)
Clean area → Air shower / Airlock → Second change room (Remove clothes in reverse order according to the wearing sequence and place them in the designated recycling area)
Hand washing and disinfection → Changing room (replacing personal clothes, taking out personal belongings)
Exit passage from the clean area
3. Indoor Behavior Prohibition (Must be Complied With)
Prohibit running, jumping, rapid walking and large movements (to reduce dust)
No eating, drinking, smoking, chewing gum, applying makeup or combing hair.
Do not touch the surface of the product or equipment with bare hands. Replace the gloves immediately if they are damaged.
No non-essential items (such as pens, paper, mobile phones, etc.) are allowed to be brought in.
Keep the conversation at a low volume and avoid breathing close to each other's faces.
II. Material/Item Inbound/Outbound Process
1) Enter the process
1. Unpacking area (buffer room / unpacking room)
The outer cardboard boxes/plastic bags of the materials are removed in the non-clean area, leaving only the clean inner packaging.
The inner packaging was thoroughly wiped with 75% alcohol/isopropyl alcohol and left to stand for at least 10 minutes.
2. Transfer window / Airlock
Place in the double-door interlocking transfer window, close the outer door → Turn on the ultraviolet lamp and let it shine for at least 30 minutes
Open the inner door to retrieve. It is strictly prohibited to open both the inner and outer doors simultaneously.
3. Registration and Storage
Record: Material name, batch number, quantity, cleaning/disinfection time, person in charge
Storage: At least 20 cm above the ground and 30 cm away from the wall. Follow the first-in-first-out principle. Keep sealed and protected from moisture.
2). Exit/Abandon the Logistics Process
Waste is collected in sealed and clean containers and is promptly removed through the transfer window.
Dangerous/biological waste is separately packaged, sterilized under high pressure, then removed and disposed of in a classified manner.
III. Equipment Operation and Maintenance Specifications
1). Admission / Entry
New equipment/tools: First, clean and disinfect in the buffer room, then pass through the transfer window to enter.
Equipment material: Non-dusting, easy to clean, low-volatile lubricant
2). Daily Operations
Before startup: Check the pressure difference, temperature and humidity in the clean area, as well as the status of the filters.
During operation: Handle with care. The surface of the equipment should only be wiped with a dust-free cloth and alcohol/IPA.
After shutdown: Cover with a dust cover, promptly clean any remaining debris, and return to the original position for storage.
3). Maintenance
Regular cleaning: Wipe the surface daily, clean the interior weekly, and conduct a deep cleaning monthly.
Filter: Medium-efficiency filters are replaced based on pressure difference or cycle; High-efficiency filters are inspected for leaks annually. If there is a leak, they should be replaced immediately.
Record: Maintenance time, content, replaced parts, operator
IV. Environmental Cleaning and Disinfection SOP
1) Cleaning frequency (according to cleanliness level)
Daily: Floor, countertop, equipment surface, door/window/door handle, trash can
Weekly: Walls, lamps, air vents, transfer windows (both inside and outside), floor drains
Monthly/Quarterly: Ceiling, efficient air vents, deep disinfection, bacterial test monitoring
2). Cleaning Procedure
Preparation: Special dust-free cloth, mop, 75% alcohol/quinacrine disinfectant, dust-removing roller
Sequence: Ceiling → Wall → Equipment → Worktop → Floor (To avoid secondary pollution)
Method: Use a dust-free cloth to dip in the disinfectant and wipe in one direction without repeating. For the floor: First vacuum → then wet mop → then clean with a dust roller; Transfer window / air shower: Wipe the inner and outer surfaces daily, and turn on the UV light regularly.
3). Disinfection Management
Disinfectant: 75% ethanol, isopropanol, quaternary ammonium salts, hydrogen peroxide, used in rotation (to prevent drug resistance)
Space disinfection: Ultraviolet irradiation for at least 30 minutes before and after each shift; Chemical fumigation/spraying once a month
Monitoring: Conduct regular tests for planktonic bacteria, settled bacteria, and surface microorganisms. Production can only commence when the results meet the standards.
V. Key Parameters and Compliance Requirements
Pressure difference: The pressure difference between the clean area and the non-clean area should be ≥ 10 Pa; adjacent clean areas maintain the pressure difference according to their respective grades.
Humidity: Generally, the temperature is 20–26℃, and the humidity is 40%–60% (adjusted according to the process)
Wind speed/ventilation: Laminar flow: 0.3 - 0.5 m/s; Turbulent flow: Ventilation frequency determined based on the turbulence level.
Bacterial test: The settled bacteria, suspended bacteria, and surface bacteria all meet the standards of the corresponding cleanliness levels.
Record: All operations, cleaning, maintenance and monitoring must be documented in writing or electronically, and be traceable.
VI. Emergency and Abnormal Handling
Pollution leakage: Immediately stop the operation, isolate the area, conduct cleaning and disinfection according to the plan, and then resume after assessment.
Pressure difference / abnormal temperature and humidity: Shut down the equipment, investigate the air conditioning system, repair it, and then monitor for qualification before resuming operation.
Personnel injury/pollution: Immediately exit the clean area, follow the medical/disinfection procedures, and replace the protective gear.
VII. Training and Management
All personnel must undergo training and assessment on cleanroom regulations, changing procedures, aseptic operations, and emergency handling.
Regular refresher training and health check-ups (no infectious diseases, no open wounds)
Limit the maximum number of people in the clean area (for example, ISO 5 class ≤ 4 people), to avoid excessive contamination.
