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Modular Clean Room Lab Laboratory Dust Free Cleanroom for Pharmaceuticals
Clean rooms are designed to control contamination either by managing contamination to low levels within the environment or more preferably by keeping contamination outside the controlled environment to begin with.
The use of clean rooms has traditionally been the chief strategy in combating contamination and particle-induced defects. Monitoring particulate contamination and controlling processing variables, through feedback and feedforward of defect information, help establish high yields for process steps carried out in the clean room. Air whose temperature and humidity is tightly controlled enters clean rooms through efficient particulate air filters and then is made to flow as laminarly as possible. This minimizes the sideways dispersion of contaminants generated in the room.
Clean room facilities
General clean room and associated controlled environments are classified in the UK and Europe by the International Organisation for Standardisation (ISO) Standards. ISO 14644 Parts 1 to 8 cover clean rooms and associated controlled environments. Part 1 provides classification of air cleanliness through the control of airborne particulate contamination to levels appropriate for accomplishing contamination sensitive activities.10 This standard identifies various classes of clean room and clean room zones, ranging from ISO Class 1 through to ISO Class 9, where ISO Class 1 is the cleanest environment. Each ISO Class stipulates the maximum concentration limits (particles/m3 of air) for a range of particle sizes from ≥ 0.1 μm to ≥ 5.0 μm. In the United States, the US Federal Standard 209E – Airborne Particulate Cleanliness Classes in Clean rooms and Clean Zones – is still widely referred to, although this particular guidance was withdrawn in 2001 in favour of the guidance outlined in ISO 14644. US STD 209E again uses particulate count to establish differing Classes of clean room, namely Classes 1, 10, 100, 1000, 10 000 and 100 000 which broadly equate to ISO classes 3, 4, 5, 6 , 7 and 8.
WHAT IS A MODULAR CLEANROOM?