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1. Choice of O&M Mode: In-house Team or Outsourcing? Let Data Decide
Core question: Should cleanroom operation and maintenance be handled by an in-house professional team or outsourced to a third party?
Key data: A nationwide survey of 1,308 hospital clean operating rooms showed that 25.7% of cleanrooms failed to meet the national standard GB 50333. Among all influencing factors, the maintenance mode was the most critical. Cleanrooms maintained by professional teams had a much higher compliance rate than those that were outsourced or left without proper maintenance. Statistical analysis indicated that professional maintenance reduced the risk of non-compliance by nearly 50%.
Recommendation: This does not mean outsourcing is bad, but it highlights the importance of being professional. If the outsourced team lacks cleanroom expertise and only treats it like ordinary HVAC equipment, it is better to train your own staff. Frequent testing is also essential: cleanrooms tested at least once a year showed a significantly higher compliance rate than those tested occasionally or not at all.
2. Personnel Management: If People Are Not Controlled, Everything Else Is Meaningless
Core principle: The largest source of contamination in a cleanroom is people.
At the Radiopharmaceutical Cleanroom of the University Medical Center Groningen (Netherlands), researchers analyzed 12 years (2010–2022) of environmental monitoring data. Results showed that the environmental compliance rate of Grade A areas (high-risk aseptic zones) was significantly lower than in other areas.
This indicates that the most critical areas are actually at the highest contamination risk. The study concluded that cleaning and disinfection procedures must be improved and aseptic operation methods optimized.
Practical solution: Mature technologies are now available for personnel control. By combining RFID chips embedded in clean garments with iris recognition, personnel identity can be precisely linked to protective equipment. The system automatically records garment washing, sterilization, and usage status, preventing unclean garments from entering clean areas. This solution has already been deployed in nearly 3,500 enterprises.
Quantified result: After a semiconductor workshop adopted a digital personnel management system, the rate of personnel violations decreased by 30%, and the cleanliness compliance rate increased from 92% to 99.5%.
3. Equipment Maintenance: HEPA Filters Are the Heart — Do Not Wait Until They Are Clogged
Core data: High-efficiency particulate air (HEPA) filters can remove more than 99.97% of particles ≥0.3 μm. However, filtration efficiency declines with service time.
New technology: Traditionally, filters are replaced on a fixed schedule (e.g., once per year). Smarter solutions are now available.
In a Class 100 operating room project at the First Affiliated Hospital of China Medical University, the O&M team used IoT technology to collect equipment operating data and applied AI algorithms to predict filter life and monitor fan failures in advance. Environmental parameters and maintenance records were automatically stored in the cloud, supporting GMP audit traceability.
Practical results: Compared with periodic replacement, AI-based predictive maintenance can extend filter service life by 15–25% while avoiding energy waste caused by clogging.
4. Environmental Monitoring: Pressure Recovery Within 5 Seconds Is a Hard Requirement
Key indicators:
· Pressure differential: Static pressure difference between clean and non-clean areas ≥ 10 Pa; between different cleanliness grades ≥ 5 Pa.
· Recovery time: When door opening causes pressure imbalance, the intelligent control system must restore the pressure gradient within 5 seconds.
Smart upgrade: Modern cleanrooms have moved beyond manual recording. By integrating sensor networks through an EMS (Energy Management System), temperature, humidity, pressure differential, particle counts, and microbial concentration are monitored in real time.
When abnormalities occur, the system automatically alarms and initiates emergency modes.
Quantified effect: After introducing 24-hour online monitoring, one electronic components company reduced its non-conforming batch rate by more than 30% within six months.
5. Cleaning and Disinfection: Data Show That Grade A Areas Require Stricter Strategies
Warning from the Netherlands: Research at the University Medical Center Groningen showed that contamination recovery rates in cleanroom conditions are about 10%, which is considered “acceptable.” However, the frequency of exceeding limits in Grade A areas was significantly higher than in other zones.
Operational key points:
· Zonal cleaning: Use different-colored cleaning tools for different cleanliness grades to prevent cross-contamination.
· Disinfectant rotation: Regularly rotate disinfectants with different active ingredients to prevent microbial resistance.
· Verification method: Use ATP bioluminescence testing to rapidly assess surface cleanliness. Data from a pharmaceutical company showed that surface cleanliness compliance increased by 18% after adopting ATP testing.
6. Data Management: Without Traceability, It Is as If Nothing Was Done
Compliance requirement: What do GMP and ISO audits check? Records.
Smart solution: Adopt a digital production management system (e.g., Jiandaoyun or similar platforms) to establish a closed-loop data chain:
· Each operation has a responsible person and timestamp
· All changes are fully recorded and cannot be lost or tampered with
· Problematic products can be quickly traced to specific batches and responsible personnel
Case: After migrating all logs online, a pharmaceutical company achieved “who fills, who checks, who signs,” significantly improving audit efficiency and transparency and providing strong support for successful GMP re-certification.
7. Continuous Improvement: PDCA Cycle Improves Settling Bacteria Compliance Over Three Years
Methodology success: A study published by the Infection Control Office of Nanjing Drum Tower Hospital showed that applying the PDCA (Plan–Do–Check–Act) cycle significantly improved clean operating room air quality.
Specific actions: The team identified risk factors in equipment operation and maintenance, analyzed the current situation, formulated improvement plans, implemented them, tracked results, and regularly summarized outcomes.
Quantified result: After three years of PDCA management, the compliance rate of average settling bacteria concentration in Class I operating areas showed a significant improvement. This proves that with the right method and persistent effort, cleanroom air quality can be continuously improved.
8. Special Environment Response: O&M Strategies for High Altitude and Extreme Climates
Case: A hospital located at an average altitude above 4,000 meters experienced performance fluctuations and higher failure rates of medical equipment due to the plateau environment, combined with difficult transportation and long logistics cycles.
Countermeasures:
· Increase inspection frequency
· Stock sufficient critical spare parts
· Establish remote technical support channels
· Provide special allowances and health protection for on-site engineers
Lesson: Cleanroom O&M cannot rely on a single universal solution. Strategies must be adapted to local environmental conditions.
9. Energy Management: Balance Cleanliness and Cost Control
Industry challenge: Cleanrooms are typically high-energy-consumption facilities due to fresh air treatment, recirculation air, cooling, and dehumidification.
Energy-saving data:
· Variable-frequency chillers and pumps can adjust operation according to load, achieving 15–25% energy savings.
· Heat recovery systems should achieve ≥ 60% waste heat utilization (as required by standards in regions such as Shanghai).
· Dry–wet separated HVAC systems (MAU + FFU + DCC) can save over 30% energy during transitional seasons compared with traditional return-air systems.
Smart optimization: Using EMS historical data to optimize temperature and humidity setpoints. For example, relaxing RH control from 45% ±5% to 50% ±5% (while meeting process requirements) can save 8–10% of annual cooling energy.
10. Standards and Compliance: Are You Ready for the New National Standard in 2026?
Major change: From May 1, 2026, the national standard GB/T 46376-2025 “Cleanrooms and Associated Controlled Environments — Operation and Maintenance Services” will be officially implemented.
Scope: This standard specifies principles, content, requirements, evaluation, and improvement for O&M services of cleanrooms and related controlled environments.
What needs to be done:
· Review existing O&M management systems against the new standard
· Improve service content and requirements
· Establish evaluation and improvement mechanisms
· Ensure O&M services meet industry process and application needs
One-sentence reminder: Do not wait until inspections arrive — start preparing now.
Conclusion
Cleanroom operation and maintenance is a marathon with no finish line.
Design can follow existing drawings, and construction can copy mature methods, but O&M must be tailored to real conditions and improved step by step through continuous practice.
