What is a Cleanroom & What Happens in One?
What is a Cleanroom?
A cleanroom is a controlled environment in which the number of airborne particles is kept to a minimum. These particles could include contaminants such as dust, airborne microbes, aerosol particles and chemical vapors. The contamination level in a cleanroom is specified by the number of particles per cubic meter. Cleanrooms are used in industries where small particles can adversely affect the manufacturing or research process, such as the pharmaceutical, biotech, medical device, life science and electronics industries.
How Does a Cleanroom Work?
Cleanrooms minimize particulate in the air through the use of air filtration equipment. Filtration units control airflow into the cleanroom and prevent airborne particles larger than a predefined size from entering the room. High-efficiency particulate air (HEPA) filters remove 99.97% of particles with a size of 0.3 microns from the air. HEPA filters are often used in medical device cleanrooms. Ultra-low particulate air (ULPA) filters are even more effective, removing at least 99.999% of airborne particles up to 100 nanometers. These air filters will utilize either a laminar or turbulent air flow system.
Proper cleaning, maintenance and operational procedures must be followed to prevent cleanroom contamination. There should be adequate space inside for all necessary equipment, materials and personnel. The flow of materials and personnel must be controlled to further minimize the introduction of bacteria, dust, pollen and other particulates. Personnel will need to enter and exit the cleanroom through gowning rooms, airlocks and/or air showers, depending on the cleanroom classification and function. Special clothing must be worn to trap contaminants generated by the body. Gowning requirements for personnel could include lab coats, hairnets, beard nets, shoe covers, masks, gloves, goggles or multi-layered suits with a self-contained breathing apparatus. The garments used will reflect the cleanroom classification and product specifications.
How is a Cleanroom Classified?
Cleanrooms classifications are based on a number of different standards that define permissible particle limits and sterility requirements. The International Standards Organization (ISO) classifies cleanrooms according to airborne particulate cleanliness per cubic meter. These classifications range from ISO Class 1 to ISO Class 9 with ISO 1 being the “cleanest” and ISO 9 the “dirtiest.” ISO 7 and ISO 8 are the most common cleanroom classifications. ISO Class 7-8 rooms are commonly used for Class I and Class II medical devices, and most injection molded medical devices are produced in ISO Class 8.
Why Do Cleanrooms Matter for Medical Devices?
Medical and drug delivery devices are used in healthcare settings where cleanliness and patient safety are paramount. Manufacturing medical devices or building specific device components inside of a cleanroom environment helps to reduce the chances of contamination from bacteria, dust or other particulates. Air pollutants can get into the mechanisms of small medical devices and prevent them from functioning correctly. If a device is contaminated before coming into contact with a patient, it could increase the likelihood of infection. Utilizing cleanroom technology for medical device manufacturing and packaging can help to keep the finished product as clean as possible.
Gilero’s Cleanroom Solutions
Gilero facilities have a combined total of 14 cleanrooms, and the utilization of these differs based on client and project needs. Generally, our cleanroom services are used for injection molding, assembly, manufacturing, packaging and kitting. Specialized equipment, including Laminar Flow Hoods and a MULTIVAC packaging machine, are housed inside. Having multiple cleanrooms on-site helps us to better follow the sterility and regulatory standards that are necessary for producing medical devices and drug delivery products.