Cleanroom
A cleanroom is a set of facilities or one room where the quantity of airborne particles is aimed to minimize the quantity of airborne particles. Temperature, humidity and atmospheric pressure are monitored and, if necessary, controlled.
Cleanrooms exist in the pharmaceutical and bio-industries as well as in the food sector and within hospitals, pharmacies and medical technology, for example. In addition, cleanrooms are used in the electronics and optics industry and in the semiconductor industry. Robots and other automation are utilized considerably in cleanrooms so that as few pollutants as possible are escorted into the room.
Mectalent cleanroom
Mectalent has cleanrooms where we perform operations requiring strict cleanliness standards, such as equipment manufacturing and welding that demand exceptional cleanliness.
The particle levels in our cleanrooms meet the requirements of ISO 6 cleanliness classification. Personnel working in the cleanrooms use protective equipment that complies with these standards, including face masks, gloves, coveralls, and footwear. The furniture in the cleanrooms is also designed for easy cleaning.
Cleanroom classifications and requirements
The European Union has created the ISO 14644-1 cleanroom standard. The standard contains nine purity classifications, of which ISO 1 is the purest.
The Good Manufacturing Practice guideline (GMP) is a classification designed to ensure the safety and reliability of the product. The GMP classification includes all manufacturing-related matters, such as raw materials, equipment, facilities, staff hygiene and training.
GMP is divided into categories A, B, C and D purity:
- A-rated spaces are very clean areas and correspond to the ISO 4.8 purity class. These facilities are reserved for critical steps in the process. In the pharmaceutical industry, for example, the packaging of medicinal products takes place in a class A cleanroom.
- B-rated space usually surrounds class A mode. B is a state of aseptic or sterile work.
- Category C corresponds to the ISO 7 classification. A C-purity class cleanroom is an area where less critical steps of the process can be carried out.
- Category D corresponds to the ISO 8 classification. Like class C, D-rated spaces are less suitable for critical work.
Cleanroom ventilation
Ventilation plays the greatest role in keeping the cleanroom pure.
The air conditioner regulates the temperature and humidity of the cleanroom. In addition, a separate High Efficiency Particulate Air Filter (HEPA) is required. The cleanroom classification determines how many HEPA filters must be in the facility.
There is always overpressure in the cleanroom, allowing air to flow from a clean space to one that is more contaminated. Also, the amount of air in the space is high, relative to the size of the facility. In this way, the particles are removed from the space while the air changes.
Cleanrooms are given special attention in ensuring efficient air circulation. The convection air is first removed from the facility, after which it is brought back to the cleanroom via filters. The convection air contains some clean outdoor air.
Want to hear more about our ISO-certified services?
Whether your needs are in product development, the machining of small prototype batches, larger continuous productions, or the entire life cycle of equipment manufacturing, we are sure to find an affordable, high-quality solution, developed in accordance with your requirements.
Our work is framed by the certified quality systems ISO 9001 and ISO 13485, which show that the company operates in a customer-oriented and systematic manner in quality development.
The certified ISO 13485 quality system guides our work in the design and production of medical devices. It ensures that the safety requirements of legislation are met as well as risk management at various stages of the product's life cycle.
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Matti Ojala
+358 20 7419 404
Juha-Matti Helisten
+358 20 7419 432
Jari Maijanen
+358 10 5565 208