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 has a cleanroom where we perform activities that meet strict purity requirements, such as washing and packaging optical devices or surgical implants. Our cleanroom includes laser welding equipment and ultrasonic cleaners.
Our cleanroom corresponds to ISO 8 purity classification and complies with purity class D of the GMP regulation. In addition, we have the capability to upgrade our cleanrooms to the more demanding ISO 6 class, if such needs and requirements arise.
Staff working in the cleanroom wear compliant protective equipment such as face masks, gloves, hoods, overalls and footwear. The furnishings in the space are also designed to be easily cleaned.
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:
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.
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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