Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process. They vary in size and complexity, and are used extensively in industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device and life sciences, as well as critical process manufacturing common in aerospace, optics, military and Department of Energy.
A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.
Personnel selected to work in cleanrooms undergo extensive training in contamination control theory. They enter and exit the cleanroom through airlocks, air showers and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.
Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets, or as extensive as fully enveloped in multiple layered bunny suits with self contained breathing apparatus.
Cleanroom clothing is used to prevent substances from being released off the wearer's body and contaminating the environment. The cleanroom clothing itself must not release particles or fibers to prevent contamination of the environment by personnel. This type of personnel contamination can degrade product performance in the semiconductor and pharmaceutical industries and it can cause cross-infection between medical staff and patients in the healthcare industry for example.
Cleanroom garments include boots, shoes, aprons, beard covers, bouffant caps, coveralls, face masks, frocks/lab coats,
gowns, glove and finger cots, hairnets, hoods, sleeves and shoe covers. The type of cleanroom garments used should reflect the cleanroom and product specifications. Low-level cleanrooms may only require special shoes having completely smooth soles that do not track in dust or dirt. However, shoe bottoms must not create slipping hazards since safety always takes precedence. A cleanroom suit is usually required for entering a cleanroom. Class 10,000 cleanrooms may use simple smocks, head covers, and booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all, boots, gloves and complete respirator enclosure are required.
| Class | maximum particles/m3 | FED STD 209E
equivalent |
| >=0.1 µm | >=0.2 µm | >=0.3 µm | >=0.5 µm | >=1 µm | >=5 µm |
| ISO 1 | 10 | 2 | | | | | |
| ISO 2 | 100 | 24 | 10 | 4 | | | |
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | | Class 1 |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | | Class 10 |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | | | | 352,000 | 83,200 | 2,930 | Class 10,000 |
| ISO 8 | | | | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
| ISO 9 | | | | 35,200,000 | 8,320,000 | 293,000 | Room Air |
Qinhuangdao Shenghua Import & Export Trading Co., Ltd. (Sun World International Ltd, ) is a professional trading company with advanced machinery, equipment of pharmaceutical, foodstuffs, chemical and packing material. Most of our sub-companies are members of China Pharmaceutical Equipment Industry Association, China Chemical Equipment Industry Association, the National Torch Program project implementation unit, the State Modernization of Chinese Medicine Science and Technology Industry, Zhejiang equipment manufacturing base of the backbone enterprises of Zhejiang Provincial science and technology for small and medium scale enterprises, high-tech enterprises, pharmaceutical equipment and technology strategic alliance member unit. With a sound quality assurance system, our company passed ISO9000: 2000 International Quality System certification and CE certification.
At present, our products have been exported to more than seventy countries all over the world such as South Korea, India, Denmark, Russia, Georgia, Bangladeshi, Ethiopia, Finland, the United States, Canada, Australia, Spain, Colombia and Croatia. And we have set up friendly business relations with nearly one hundred foreign companies and established long-term agent business relations with Romanian and Colombian distribution companies.
What's more, we have a special team with some excellent professional engineers who can design special pharmaceutical machines according to the clients' requests. Facts speak louder than words. We had already successfully designed and produced high speed sachet packing machine for Indian clients in 2004, which is a new high speed and intelligent packing machine in the world, we finished it all by ourselves from the design to the final product. As the requirements of clients, we cooperated with Spanish Water Purity Company to establish water supply system market. We designed and promoted water supply project, and made it bloom fast in Spanish with our great effort. Our products win the market not only because of advanced technique and reliable quality with the favorable price, but also of our brilliant design team.
