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Core Cleaning Standards for Cleanrooms (Reduced Version)
2026/2/4
01. Core cleaning principles
1. Hierarchical cleaning: Develop plans based on ISO 1-9 levels / GMP A-D levels. For high-clean areas (ISO 5+), use precision tools and the cleaning sequence is "high → low" to prevent cross-contamination;
2. Airflow operation: Clean along the vertical / horizontal laminar flow direction to avoid disturbing the airflow;
3. Sterile and low dust: Tools in sensitive areas need to be sterilized (high temperature / ultraviolet rays), and personnel must be strictly protected;
4. Minimal intervention: Minimize touching equipment and confirm operating procedures before cleaning.
02. Simplified preparation work
1. Personnel
They need to undergo specialized training and assessment, and receive regular refresher training (once every quarter); for high-clean areas (ISO 5-7), wear full-body clean suits + powder-free gloves, go through air showers; for low-clean areas (ISO 8-9), wear separate suits + shoe covers, and perform hand disinfection (75% alcohol); have no colds / skin injuries, do not wear jewelry, and wrap long hair tightly.
2. Tools (Disable ordinary cotton items)
3. Environmental Confirmation
Cleaning during shutdown (night / maintenance period); Before cleaning, measure the cleanliness level using a particle counter. If it exceeds the standard, investigate (filter / personnel); Power off the equipment, and ensure there is no obstruction in the fire escape route.
03. Key Operating Procedures (by Area)
1. Floor (60%)
First, use HEPA vacuuming (in the direction of the airflow, repeat in dead corners twice); then, wet wipe (hand wipe in high cleanliness area, mop in low area, with overlapping trajectory 1/3); finally, disinfect (75% alcohol), wipe off the residue with purified water after evaporation; Inspection: White gloves without stains, particle count meets the standard. 2. Wall / Ceiling (once every 2 weeks, once a week in high cleanliness area)
Long pole ultra-fine cloth from top to wall, from the air outlet outward to wipe; for protruding areas (switch / sign), use a small cloth dipped in purified water to wipe; Check the HEPA filter rubber strip, if damaged, stop and report for repair. 3. Equipment Surface
Confirm the clean area (sensors, etc.), cover with cling film; Use dust-free cotton swabs to wipe gaps, rotate clockwise in a spiral pattern on large surfaces; Equipment in contact with products is disinfected with 0.1% peracetic acid, leave it to stand for 30 minutes, then wipe twice with purified water; Inspection: No stains, microorganisms ≤ 1 CFU/100cm² (GMP A grade). 4. Auxiliary Area (buffer room / air shower room / changing room, daily cleaning)
Buffer room: Wipe door handles, mop the floor, clear the trash can; Air shower room: Clean the nozzles, check the air shower time (15-30 seconds); Changing room: UV disinfect the cabinets for 30 minutes, classify and store consumables.
04. Core Precautions
1. No running, tools are dedicated to each area, cleaning agents are prepared and used immediately (≤ 4 hours), waste is sealed;
2. Liquid spills on equipment: Absorb, power off and report for repair immediately; Cleanliness drops sharply: Stop cleaning and check the cause; Personnel feel unwell: Evacuate immediately;
3. QA inspection after cleaning (stains / particles / microorganisms), fill in the record sheet and archive for at least 1 year.
05. Simplified Management Key Points
1. Personnel: Establish files, conduct physical examinations every half year, operate in the high cleanliness area with two people;
2. Tools: Store by area, disinfect daily, set a lifespan (cloth ≤ 50 times, HEPA filter every 3 months replaced);
3. Frequency: Core area (ISO 5-6) floor is cleaned daily, equipment is cleaned every 2 days; Auxiliary area (ISO 7-8) floor is cleaned every 2 days;
4. Emergency: Have a pollution contingency plan (quarterly drills), prepare backup filters / clean suits.
06. Quick Solutions to Common Problems
