Cleanrooms are essential in industries such as pharmaceuticals, biotechnology, microelectronics, and aerospace, where the control of contamination is critical to product integrity and safety. To meet stringent standards, many facilities implement ISO classified cleanrooms, categorized by their level of cleanliness based on the number of particles per cubic meter of air. Maintaining these clean environments is a challenging task that requires strict adherence to ISO standards. This article explores the best practices for ISO classified cleanroom cleaning to ensure contamination control is maintained at all times.
Understanding ISO Classified Cleanrooms
ISO classified cleanrooms are rated from ISO Class 1 to ISO Class 9, with Class 1 being the cleanest and Class 9 the least stringent. The classification system is based on the number of airborne particles, both viable (living organisms like bacteria) and non-viable (dust and chemical particles), permitted per cubic meter. The most common ISO classifications in industries are ISO 5, ISO 7, and ISO 8. Each classification dictates the acceptable level of particles and the cleaning protocols needed to maintain cleanliness.
To meet these requirements, cleanroom cleaning processes must be robust, systematic, and regularly monitored. Proper ISO classified Cleanroom cleaning is vital to prevent contamination that could compromise the product or process.
Best Practices for ISO Classified Cleanroom Cleaning
1. Use of Proper Cleaning Agents
Not all cleaning agents are suitable for cleanrooms. It’s essential to use cleaners that are approved for use in ISO classified environments and are compatible with the materials used within the cleanroom. The ideal cleaning agents should be non-toxic, non-reactive, and should not leave any residues that could generate particles. Commonly used cleaning agents include sterile water, isopropyl alcohol, and hydrogen peroxide solutions.
For ISO 5 and 6 cleanrooms, it’s important to use sterile and lint-free wipes soaked with the appropriate cleaning solutions. Disinfectants must also be regularly rotated to prevent microbial resistance.
2. Training and Documentation
Effective ISO classified cleanroom cleaning starts with the proper training of personnel. All cleaning staff should receive comprehensive training on the unique requirements of cleaning in ISO environments. This includes wearing the correct personal protective equipment (PPE), following gowning procedures, and understanding the layout of the cleanroom to avoid cross-contamination.
Documentation is also key to maintaining contamination control. Detailed cleaning logs should be maintained to track what areas have been cleaned, what cleaning agents were used, and any observations that may impact cleanliness. Regular audits of cleaning procedures ensure that the facility remains compliant with ISO standards.
3. Cleaning From Top to Bottom
The airflow in a cleanroom generally moves from top to bottom, with ceiling vents filtering clean air down toward the floor. To avoid disturbing settled particles, cleanrooms should always be cleaned from the top of the room to the bottom. This means starting with ceiling surfaces, light fixtures, and vents, then moving down to walls and equipment, and finally cleaning the floor.
This cleaning method helps ensure that any particles dislodged from higher surfaces are captured and removed as cleaning progresses downward. For ISO classified cleanrooms, this process must be done meticulously, as even a minor disturbance in air quality can compromise the controlled environment.
4. Regular and Scheduled Cleaning
Cleanroom cleaning is not a one-time process; it must be conducted regularly to maintain compliance with ISO classifications. Cleaning schedules should be determined based on the classification of the room and the activity level within it. For example, an ISO 5 cleanroom, where critical processes take place, may require more frequent cleaning than an ISO 8 room used for less sensitive tasks.
Scheduled cleaning tasks should include daily, weekly, and monthly duties to ensure every surface and piece of equipment remains particle-free. Some facilities also perform cleaning between shifts to further minimize contamination.
5. Cleaning Equipment and Tools
The tools used for ISO classified cleanroom cleaning are just as important as the cleaning agents. Mops, wipes, and vacuums should be specifically designed for cleanrooms, using low-shedding, lint-free materials. Vacuum cleaners should be equipped with HEPA (High-Efficiency Particulate Air) filters capable of trapping particles as small as 0.3 microns, ensuring they do not recirculate into the cleanroom air.
Additionally, tools should be color-coded to prevent cross-contamination between different areas of the cleanroom, such as gowning rooms, production areas, and storage spaces.
6. Air Filtration System Maintenance
Maintaining the air filtration system is a critical component of ISO classified cleanroom cleaning. Air handling units (AHUs) and HEPA filters must be regularly inspected and replaced as needed to maintain optimal airflow and particle control. Regular monitoring of air quality is essential to ensure that the cleanroom remains within the ISO classification requirements.
Conclusion
Effective ISO classified cleanroom cleaning is essential to maintaining contamination control and ensuring that products are not compromised. By adhering to proper cleaning protocols, using appropriate cleaning agents and tools, and following strict schedules, facilities can meet ISO standards and reduce the risk of contamination. Ensuring that personnel are well-trained and that documentation is thorough will further contribute to the successful maintenance of ISO classified cleanrooms. Cleanliness is not just a requirement in cleanrooms—it is the cornerstone of ensuring the highest level of product safety and process integrity.