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The skills and qualifications required for the operation and maintenance personnel of Class 10, Class 100, Class 1,000 and Class 10,000 cleanrooms
2025/11/6
01 Core Skill Requirements
Knowledge and operational skills of Class 10, Class 100, Class 1,000 and Class 10,000 cleanroom systems
Mastering equipment principles: Familiar with the working principles of the core systems in cleanrooms, including the operation logic and parameter adjustment methods of air conditioning and purification systems (such as AHU, FFU, primary, secondary and high-efficiency filters, air ducts, humidifiers, etc.) (such as air volume, temperature and humidity, and pressure difference control). The sealing principle and maintenance key points of the enclosure structure (color steel plate, sealant, transfer window, air lock chamber) (such as gap repair, material properties). Calibration methods and data interpretation of monitoring systems (particle counters, temperature and humidity sensors, differential pressure gauges) (such as ISO 14644 cleanliness grade determination). Practical skills: Capable of independently completing equipment maintenance operations, such as: replacement of high-efficiency filters (including PAO leak detection operations), cleaning/replacement of medium-efficiency/primary efficiency filters. Daily maintenance of fans and motors (such as bearing lubrication and vibration detection), and adjustment of air valves. Basic operations of the automatic control system (PLC/DCS) (such as parameter setting and alarm handling). 2. Industry-specific technical capabilities
The key points of operation and maintenance for cleanrooms in different industries vary, and it is necessary to master them specifically
Pharmaceutical/medical industry: It is necessary to understand the requirements for microbial control (such as disinfection and sterilization methods, detection of airborne bacteria/settled bacteria), and the traceability requirements for equipment maintenance in GMP standards. Semiconductor/electronics industry: Familiarity with particle control (such as sub-micron particle detection) and anti-static system maintenance (grounding resistance detection, static elimination equipment calibration) is required. Food/cosmetics industry: It is necessary to master the cleaning standards for sanitary equipment (such as the CIP in-situ cleaning process) and the usage norms of food-grade lubricants. 3. Safety and emergency response capabilities
Safety Operation: Be familiar with the safety regulations of cleanrooms, including: electrical safety (operation of high-voltage equipment, leakage protection), and mechanical safety (locking and hanging plate procedures during fan impeller maintenance). Chemical safety (such as the correct use and protection of disinfectants and cleaning agents). Emergency response: Capable of quickly handling sudden malfunctions, such as the traceability process when the cleanliness level exceeds the standard (troubleshooting for filter leaks, personnel operations, and equipment failures). Emergency measures in case of power failure or air supply interruption (activate backup power supply, isolate contaminated areas). 4. Document management and compliance capabilities
It can standardize the recording of maintenance data (such as filter replacement time, parameter detection results, and fault handling reports), ensuring compliance with industry traceability requirements (such as the "traceability" clause of GMP). Understand and implement the specific requirements for operation and maintenance in industry regulations (such as ISO 14644, SEMI, GMP) to ensure that maintenance behaviors are compliant.
02 Essential Qualifications and Certifications
1. Basic qualifications
Education and professional background: Generally, a secondary vocational school degree or above is required, with a relevant major (such as HVAC, clean technology, mechatronics, pharmaceutical engineering, etc.), and a certain basic knowledge of mechanics, electricity, and air conditioning systems is required.
Special operation qualification: A certificate is required when operating special equipment, for example:
Electrician Certificate (High Voltage/Low Voltage) : It is used for the maintenance of electrical equipment (such as fan motors, automatic control systems). Welder's certificate: Used for welding and repairing stainless steel pipes and enclosure structures (in some scenarios). Special equipment operation certificate (such as pressure vessel certificate) : If the cleanroom contains equipment such as autoclaves. 2. Industry-specific certifications
Specialized certification for cleanrooms
Industry compliance certification: Pharmaceutical industry: Familiarity with GMP standards is required. Some enterprises demand that their employees hold a "GMP Internal Auditor" or a "Good Manufacturing Practice Training Certificate for Drugs". Semiconductor industry: It is necessary to understand SEMI standards (such as SEMI S2/S8 safety specifications), and some enterprises require relevant training and certification. Cleanroom operator/Maintenance Technician certification: Issued by industry associations or professional institutions (such as the "Cleanroom Technical Qualification Certification" of the Chinese Institute of Electronics, the certification of the International Cleanroom Association (ICRA)), it proves that one has the basic operation and maintenance capabilities of cleanrooms. Filter installation/leak detection qualifications: Some industries require personnel for high-efficiency filter replacement and PAO leak detection to hold specialized qualifications (such as operation certification in compliance with ISO 14644-3 standards). 3. Third-party testing and calibration qualifications (for specific positions)
If the calibration of monitoring equipment (such as particle counters, temperature and humidity sensors) is involved, a metrological calibrator certificate (in compliance with national metrological standards) must be held. If responsible for the performance testing of cleanrooms (such as regular testing commissioned by a third party), one must possess the relevant operational qualifications of a CNAS laboratory or industry-recognized testing qualifications.
03 Soft Power Requirements
Meticulousness and rigor: Deviations in cleanroom parameters (such as a pressure difference of 1Pa) may lead to production risks. It is necessary to have a high sense of responsibility, strictly follow the procedures and keep records. Learning ability: Cleanroom technology (such as intelligent operation and maintenance systems, new filter materials) is constantly updated, and it is necessary to continuously study industry standards (such as the revised ISO 14644) and equipment technical manuals. Communication and collaboration: It is necessary to effectively collaborate with the production department (to understand the working conditions and requirements), equipment manufacturers (to obtain technical support), and third-party testing institutions (to cooperate with testing) to ensure that the operation and maintenance plan is adapted to the actual needs.
04 Summary
The core capabilities of cleanroom operation and maintenance personnel can be summarized as "solid technical skills, proficient compliance, efficient emergency response, and meticulous responsibility". Qualifications should be configured in combination with industry characteristics (such as GMP for pharmaceuticals and SEMI for semiconductors) and specific positions (such as requiring an electrician's certificate for electrical maintenance). Enterprises usually ensure that personnel capabilities meet the high requirements for the stable operation of clean rooms through a combination of internal training and external certification.
