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Management and Requirements of Clean Rooms
2026/8/27
1. Personnel Management (The biggest source of pollution in the cleanroom)
Entry and changing procedures
Personnel passage: change shoes → first change (remove outer clothing) → second change (wash hands and disinfect, wear clean clothing, cap, mask, gloves) → air shower (blow shower for ≥ 15 seconds, double doors interlocked) → clean area. Clean clothing grade matches the area: A/B level fully covered, hair and beard fully covered, head cover inserted into the collar; C level tightens cuffs; D level covers hair only. Behavior requirements
Prohibit makeup, applying nail polish, wearing watches, jewelry; prohibit bringing mobile phones and snacks into the clean area; no running, large amplitude shaking, or patting clothes indoors; actions should be gentle to reduce dust. Dealing with masks and gloves in the clean area is not allowed; hands should be regularly disinfected; personnel with colds or skin diseases are prohibited from entering the high-level clean area; report any abnormal conditions to Anhui Province's pharmaceutical... 。 Strictly control the number of people, with an average area of ≥ 4㎡ per person. Only necessary operation personnel are allowed to enter. Visitors need to be approved and monitored throughout the process. The pharmaceuticals in Anhui Province are strictly controlled.
Clean clothing management
Special clean clothing is stored in separate areas, and is cleaned and sterilized regularly; damaged or fibers falling off should be replaced immediately, and it is not allowed to wear out of the clean area. Training and assessment: On-the-job training on clean room SOP, regular refresher training, and brief explanations for visitors before entering the area.
II. Materials and Logistics Management
The flow of people and logistics are strictly separated and do not cross; materials: Remove the outer packaging in the outer area → Clean and disinfect the outer surface → Buffer room / Cargo shower room / Transfer window → Clean area. The double doors of the transfer window are interlocked, and it is strictly prohibited to open both doors at the same time; UV disinfection can be equipped, only used for small items; large items are transported through the cargo shower room. Items that are prone to shedding fibers and generating dust should be avoided from entering the clean area. Materials and tools in the clean area are dedicated, and labels should be made; Waste is sealed and collected, transported out from a dedicated exit, and not piled up in the clean area. Materials and tools entering should remove the outer packaging to avoid bringing in contaminants from the outer packaging; The transfer cart is dedicated for each area, and is disinfected regularly.
III. Environmental and Air Conditioning System Management
Pressure difference (gradient pressure difference): The higher-level clean area maintains positive pressure relative to the lower-level clean area, and the pressure difference between adjacent rooms is generally 10-15Pa; Prevent low-level pollution from flowing back; Doors should be opened as little as possible, and the opening time should be shortened. Temperature and humidity: Controlled according to process requirements, generally temperature 18-26℃, relative humidity 40-65%; The humidity in areas with high anti-static requirements should not be too low. Operation of the purification system: Start the self-cleaning 30-60 minutes before production, and operate after reaching the cleanliness level; Shut down the system according to procedures, and do not randomly turn off the purification air conditioning. Maintenance of filters: Regular cleaning and replacement of primary and secondary filters; HEPA high-efficiency filters are regularly inspected for leaks, and replacement is immediate if the leakage exceeds the standard. The enclosure structure (walls, ceilings, floors) should be kept intact, and no holes should be randomly drilled; Wall and floor surfaces should not be drilled, and the cleanliness should be re-verified after maintenance.
IV. Equipment and Tool Management
Equipment should prioritize low dust production and easy-to-clean materials; Seams of equipment should be sealed to reduce dust accumulation dead zones. Equipment surfaces should be cleaned daily; Use clean room-specific dust-free lubricating oil for lubrication to prevent oil contamination of the environment. Equipment maintenance should be completed outside the clean area as much as possible; When maintenance is required in the clean area, isolation and protection should be done, and thorough cleaning should be carried out after the maintenance, and testing for qualification is necessary before resuming production. Tools and fixtures are dedicated to each area, and are cleaned and disinfected regularly, and stored at fixed locations.
V. Cleaning and Disinfection Management
Use dust-free cloths and dedicated clean tools, and prohibit ordinary mops and rags; Cleaners and disinfectants are used alternately to prevent microbial resistance. Frequency: Clean the floor and tabletop after each operation; Regularly wipe the walls, doors, transfer windows; Deep cleaning of air outlets and ceiling gaps is done regularly. Cleaning sequence: From the higher cleanliness level to the lower level, from top to bottom, from inside to outside. Disinfectants are used according to the ratio and records are kept; UV lights are regularly tested for illuminance, and replaced when ineffective.
VI. Monitoring and Verification Requirements
Daily monitoring items: Suspended particles, floating bacteria / settled bacteria, pressure difference, temperature, humidity, key parameters can trigger online alarms, and original records should be preserved (≥ 3 years in the pharmaceutical industry, ≥ 1 year in general). Regular third-party testing: Dust particles, leak detection of high-efficiency filters, air velocity and volume, pressure difference, microorganisms. State classification: idle state, static state, dynamic state; Production is mainly based on dynamic assessment; After renovation or major repair, it must be re-verified and qualified before use. If indicators exceed the standard, immediately investigate the cause, take corrective measures, and confirm the restoration before resuming production.
VII. Document and Record Management
Compile a complete set of SOP: Personnel entry and exit, changing clothes, material entry and exit, cleaning and disinfection, system operation, equipment maintenance, abnormal handling. Operation Records: System power on/off, filter replacement, environmental monitoring, cleaning and disinfection, maintenance and renovation, handling of abnormal deviations, all recorded for traceability. Establish change management: cleanroom renovation, equipment replacement, process changes, requiring assessment of the impact on the clean environment.
VIII. Emergency Management
Power outage, air conditioning failure: Personnel evacuate in an orderly manner, close the door; after power restoration, fully self-clean, and re-enter only when the test is qualified. Leakage, pollution: Isolate the area, conduct comprehensive cleaning and disinfection, re-test and resume work only when qualified. Set up emergency evacuation channels, do not occupy the normal entry and exit channels of the clean area. Summarize key points of cleanroom management: People are the biggest source of pollution, separate the flow of people and materials; maintain gradient pressure difference; self-clean in advance; strictly clean and disinfect; regular monitoring and verification; retain the complete set of SOP and records.
