ISO 14644 is a standard developed by the International Standards Organization that specifies cleanroom design, classification, and operation methods. ISO 14644 assigns ratings from 1 to 9 for cleanrooms.
The technique assigns a rating from 1 (the cleanest) to 10 (the least sanitary) based on the number of airborne particles per cubic meter and the size of those particles. To put it another way, a lower number indicates cleaner air.
The HVAC (heating, ventilation, air conditioning) system plays a significant role in maintaining order in this space. HEPA (high-efficiency particulate air) filters, often mounted in a cleanroom’s ceiling, filter the air and remove particles as small as 0.3 microns. Vents are set up at the base of the cleanroom’s walls so the air is directed downward.
There are three questions you should ask yourself before settling on cleanroom classifications:
- What are the likely contamination sources?
- If I want to filter out particles, what size are they?
- How much air do you have to blow around if you want to get rid of the germs in a room?
Size of a Particle
When planning a cleanroom, knowing what size of particles would need to be filtered out is crucial.
Less than 35,200 particles smaller than 0.3 microns per cubic meter are required for an ISO 6 classification. These are too small for the human eye to detect. As a point of reference, the diameter of a human hair is 100 microns, whereas the threshold at which we can see individual particles is typically set at 50 microns.
ISO 1 cleanrooms are particularly unusual because they demand a constant particle density of fewer than 0.23 particles at 0.1 microns per square meter. Only a selected few locations throughout the world are able to provide the level of control needed.
People (skin flakes, oil, cosmetics, clothes waste, hair) and the process happening inside (equipment, materials, water) are the two main sources of contamination for a cleanroom environment; knowing what they are can help you design a better cleanroom. Air grills and filtration devices placed strategically can aid in maintaining a sanitary environment.
To keep contaminants out of the main cleanroom, ISO class 7 and below cleanrooms need a separate room for gowning. Any manufacturing facility, whether for pharmaceuticals or e-liquid, requires strict environmental control to prevent the spread of contaminants.
Transport of Air
Your required airflow is proportional to your categorization. Generally, it should be double that of the next highest category (so ISO 7 needs double the air circulation of ISO 8). This necessitates an increase in air conditioning, filtration, and ventilation.
Dilution of the air is aided by ventilation. Therefore, increasing the frequency of air changes will dilute the air to a safe level.
Restricted and Confidential
ISO 9 is a controlled environment with filtered air, a pressurized environment, and specific temperatures and humidity levels, but not characterized in terms of particle count, so a system was developed to help classify it.
Constructing a cleanroom to your specifications at a reasonable cost is crucial. We encourage you to get in touch with knowledgeable cleanroom experts in order to know if the particular categorization is appropriate.
New Cleanroom Technology
A wealth of helpful equipment on the market may be used to maintain a high, consistent degree of cleanliness in controlled environments like cleanrooms. The cleanroom tech market was valued at 4B$ in 2020 and is expected to grow by 5.4% YoY by 2028.
Additional technological resources are establishing cutting-edge standard-bearers to back up cleanroom teams. Recent advances in robotics have resulted in many new, lightweight, compact robot options for manufacturing.
The sophisticated motion control and handling capabilities of these robotic devices allow for unprecedented levels of efficiency and consistency in both output and precision. Robotics is a developing field, but it already enables safer manufacturing and better quality control.
The pharmaceutical, biotechnology, medical device, and battery sectors use these highly regulated conditions based on the ISO requirement of the product they manufacture. Measures are in place to limit the spread of contaminants and regulate conditions like temperature, pressure, and humidity. Many of you may not know, but even NASA uses cleanrooms. They even used one to create the Mars Rover.
The industrial sector is making great progress toward sustainability, from using eco-friendly materials and renewable energy to developing cutting-edge technology. In addition to high-quality drugs and life-saving research, more good can be placed into the world by incorporating thoughtful considerations.