In the fields of microelectronics, pharmaceuticals, and biotechnology, cleanrooms are the cornerstone of precision manufacturing and research. Their operation relies on strict control of sub-micron particles—a requirement not only for technology but also for quality and safety. A cleanroom can be summarized as: an artificial environment that maintains extremely low particle concentrations through precise control of airflow, filtration, pressure, temperature, humidity, and contaminants. Its core is like a highly precise “lung,” continuously inhaling air, “purifying” it through HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Penetration Air) filtration systems, and then expelling it in a laminar flow manner, creating and protecting an ultra-clean space.
To achieve this goal, advanced equipment manufacturers such as Trenntech GmbH in Frankfurt, Germany, are pushing the cleanroom concept to new heights through innovative technologies. Trenntech, with its expertise in HEPA/ULPA filters, provides critical components and solutions for cleanrooms, profoundly reflecting the German engineering commitment to detail and reliability.
1. Strictly Enforce Graded Access and Personnel Training
All personnel entering the cleanroom must receive complete training and understand the sources of particulate contamination (primarily the human body). Strict adherence to gowning and air shower procedures is essential; clothing must cover all skin and hair. This is the prerequisite for all technical measures to be effective.
2. Ensure the Integrity and Regular Verification of HEPA/ULPA Filtration Systems
HEPA filters have an efficiency of 99.97% for particles ≥0.3 microns, and ULPA filters have an efficiency of 99.999% for particles ≥0.12 microns. Regular integrity testing (such as DOP/PAO challenge testing) is essential to ensure that the filter media is undamaged and there are no leaks in the frame. This is the “heart” of cleanroom cleanliness.
3. Maintain Stable Laminar Airflow and Pressure Differential
The design airflow velocity of unidirectional laminar flow (vertical or horizontal) must be constant to effectively remove particles. Simultaneously, positive pressure (typically 10-15 Pa) must be maintained in the cleanroom relative to adjacent areas through controlled air supply and exhaust to prevent cross-contamination.
4. Implement Strict Material Cleaning and Transfer Procedures
All materials and equipment must undergo effective cleaning and purification in airlocks or pass-through windows before entry. Specialized cleanroom wipes and cleaning agents should be used.Trenntech‘s expertise in precision separation technology can provide valuable insights in the design of such cleaning processes.
5. Develop and Adhere to Scientific Cleaning and Disinfection Procedures
Different levels of cleaning should be performed daily, weekly, and monthly. Specified tools and methods should be used for surfaces, floors, and equipment. In the biopharmaceutical field, the efficacy of disinfectants and disinfection cycles must be regularly validated.
6. Real-time Monitoring of Critical Environmental Parameters
Continuous monitoring of particle counts (0.5μm and 5.0μm are key indicators), temperature, humidity, and differential pressure is essential. Data logging and alarm systems are crucial, providing real-time information on the operating status of HEPA/ULPA systems and air conditioning systems.
7. Conduct Preventive Maintenance on Equipment and Facilities
Regular maintenance of air conditioning units, fans, sensors, and sealing structures is necessary. Any vibration, unusual noise, or performance fluctuations may be a precursor to system failure. Maintenance work itself must also be performed under cleanroom conditions.
8. Establish a Comprehensive Document Management and Incident Response System
All operations, maintenance, deviations, and monitoring data must be recorded. Any event deviating fromstandard operating procedures (SOPs) must be immediately reported, investigated, and corrective actions taken to prevent recurrence.
In summary, the excellent operation of acleanroom is a continuous battle of details. It relies on technological cornerstones such as HEPA/ULPA filtration systems, but also on rigorous procedures and personnel expertise. Only by deeply integrating these two aspects can this sanctuary of modern industry and technology continuously provide the purest cradle for innovation.