What is a Cleanroom (sterile room, clean room, clean room)?
Cleanroom (Cleanroom), often referred to as the "sterile room" or "clean room" means a room containing, particle quantity control. Dust and contaminants do not exceed the level that is defined. It also includes controlling the factors as the speed of temperature, pressure and relative humidity levels in the room too.
The source of the contamination (Contamination)
Can break down the source of the contamination? Dust. Small particles are a problem within the sterile room (clean room) is as follows
External source (External Sources)
Most of the contamination of the external (External Sources), it can be slipped into the room, work area, in a sterile room (clean room) on an air-conditioning system (Air Makeup system case, AHU), including infiltration through cracks or leaks along the walls, ceiling, and walls of different rooms, fects.
This problem can be controlled by
- The air filter is a special type of filtration system (HEPA Filtration)
- Control voltage between interest (Critical Environment) in comparison with the external area (Space Pressurization).
- Filling cracks or leaks with silicone (Sealing of penetrations space)
Sources inside (Internal Sources)
Dust. Small particles including various contaminants (Contaminant) are often attached to the worker within the room. Whether it's from wearing clothes shoes hair. The skin, or even breathe.
Generally, the size of the dust is lalong. Contamination and tiny difference is cooler before beginning from 0.001 up to several hundred microns. Particles larger than 5 μm, which is usually found along the surface and the chance to float in the air in a short span of time.
Why is there a sterile room (clean, clean room)
The requirement of a sterile room (clean room, clean room) Arising from the issue of contaminants Small particles and dust, are from a machine worker. Manufacturing process, including the outside air. These can create problems for products or work in progress. Result that a lack of performance.
Scope of use the sterile room (clean rooms, Cleanroom) There are many interior hospital. The lab. Plant food and pharmaceutical industries, including electronic equipment factory. As follows
|Electronics||Computers, TV-tubes, flat screens|
|Semiconductor||Production of integrated circuits|
|Micromechanics||Gyroscopes, compact disc players, bearings|
|Optics||Lenses, photographic film, laser equipment|
|Biotechnology||Antibiotic production, genetic engineering|
|Pharmacy||Sterile pharmaceuticals, sterile disposables|
|Medical Devices||Heart Valves, cardiac by-pass systems|
|Food and Drink||Brewery production, unsterilized food and drink|
|Aerospace||Manufacturing and assembling of aerospace electronics|
Type of room (clean, clean room)
We can break the sterile room (clean rooms, Cleanroom) into two categories according to the flow of air inside the room. As follows
Unidirectional Flow Cleanroom.
There is a move of the air within the room as a "Laminar Flow" ideal for applications requiring protection against Cross Contamination and cleanliness is special.
Non-Unidirectional Flow Cleanroom
Resembles the movement of air within the room is a "Turbulent Flow" which is less orderly flow Unidirectional Flow Cleanroom.
International standards regarding non-infection (cleanrooms, sterile rooms)
The international standard Federal Standard 209 E (FED-209E) associated with non-infection (cleanrooms, sterile rooms) is defined as a guide for operators and users, this sterile room rooms divided into 6 classes (the Class) by the level of cleanliness in room. Details are as follows.
|Cleanroom Class||Class Limits not to exceed particles per cu.ft for particle size between|
|0.1 mm||0.2 mm||0.3 mm||0.5 mm||5.0 mm|
Current international standards, FED-209E was cancelled and replaced by the international standard ISO 14611, which use as a unit of measurement (metric) and trigger the mate called the new sub class instead of the details below.
|FED STD 209E||ISO 14644-1|