Ensuring air quality is paramount for products sensitive to environmental conditions (humidity, airborne particles, etc.). In some cases, even a grain of dust can disrupt the fabrications of certain products, specifically microchips.
There are many sources of contamination. The facility might contain spills or leaks where contaminated particles can penetrate and form on ceilings and floors. Both humans and machines can also emit contaminated particles (cosmetics, fluids, vapors, spittle, chemicals, bacteria, fungi, viruses, etc.). Even the debris of air conditioners might be a source of pollution.
Particle size is measured in microns (25,400 equals 1), and they pose a threat to product quality and fabrication processing. Therefore, cleanrooms are necessary to limit the number of those harmful practices and ensure overall cleanliness.
A cleanroom is a room or space designed and built to be as free of dust, dirt, contamination, pollen, spores, and other airborne particles as possible. Cleanrooms are used in a wide range of industries that rely on an extreme level of cleansing. Thus, they are used for everything from computer chips and circuit boards to the medical device manufacturing process of things such as pacemakers or artificial joints.
What are cleanroom usages?
Cleanrooms are used for various purposes, such as Radio Frequency (RF)-welding, heat sealing, assembly, and the packaging of multiple medical devices. It is crucial to maintain a sterile environment during all of those processes to protect the products from any kind of contamination.
Air contains about 35 million particles which are 0.5 ìnches in diameter. Whether the manufacturer is established in a rural or artificial area, the air is still prone to pollution, which can negatively affect product quality or disrupt sensitive equipment.
Properly designed cleanrooms can help companies achieve compliance with regulatory requirements and improve product quality. Also, they protect the workers and reduce the hazardous risks of becoming infected or affected by airborne practices.
How does the cleanroom work?
Cleanroom technology is based on eliminating dust and contaminated particles from the air, and it’s designed to protect both products and staff. This is achieved by supplying large volumes of filtered air. Cleanrooms must always have high-quality HEPA or ULPA filters, appropriate airflow patterns, and enclosures that isolate the cleanroom area from the surroundings.
Also, workers who enter this room should adhere to proper gowning procedures since humans and clothes are classified as the primary contaminant sources.
The mechanism of how it works is simple. First, the contaminated air is circulated to the filter system, then the filters cleanse and sterilize it according to cleansing specification, then this pure air is forced into the cleanroom. At the same time, the contaminated particles are trapped then discharged outside the cleanroom in a continuous process.
Key Elements of Cleanroom Design
Air Supply: the system diffuses sufficient volumes of air to ensure a high level of cleanliness
Air Filtration: involves the segregation of “particles” from airstreams. One or more filters must treat all air that enters a clean room, and then it’s conditioned to meet the cleanroom temperature and humidity requirements.
The most common filters used are (HEPA) and ultra-low penetration air (ULPA).
The importance of cleanrooms for medical device engineering companies
Medical device engineering and manufacturing companies produce high volumes of disposable and reusable medical devices. Those medical devices, if not assembled in an antiseptic-controlled environment, will likely harm the patients who are exposed to those devices or even the surgeons who use them, as they still include microbiological contamination. So, a cleanroom is a critical component in the medical device assembly process.
Cleanrooms are controlled environments where particle count and microbiological levels can be limited and diminished, using filters and cleaning, respectively. This ensures that the medical devices produced are particle-free and have zero harm on the people who’ll use or be exposed to them.
Safety protocols and guidelines for cleanrooms
Cleanrooms are of high importance for medical device manufacturing companies and an ideal cleanroom should abide by stringent quality standards.
All of Dravon Medical’s high-quality products are assembled and packaged in an ISO 7-certified cleanroom, minimizing the risks of pollutants that might contaminate and alter manufacturing or the final results.
Dravon Medical’s cleanroom meets cleanroom classification requirements, including:
At Dravon Medical, the quality of our medical devices and the thoroughness of our manufacturing process are critical success factors. We are dedicated to creating products that perform for you and your customers as precisely as they need to, every time!