Active Member
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[China]
Address: LTPM CHINA 2nd Floor,Dongxin Road and 5th Development Road ,Caizhai Industrial Zone, Ruian City, Zhejing Province ,China
Contact name:Chan
Leadtop Pharmaceutical Machinery |
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Pharmaceutical Clean Room modular Cleanroom
Cleanrooms are essential to any manufacturing process where
particulate contamination can affect the quality of goods produced.
Specific clean room classifications and ISO class code descriptions
provide protective guidelines and secure environments through
controlled air filtration, which lowers the possibility of product
contamination or large particulate interference within critical
process manufacturing. Specific cleanroom requirements and ISO
14644-1 cleanroom standards are used to protect consumers from any
potential flaw or mishandling of a product.
Additionally, clean room classifications require that positive
pressure is continuously maintained while the cleanroom is
operational. This process prevents contaminated air from flowing
back within the clean air environment. This process allows clean
filtered air to continuously flows from clean to less-clean spaces,
allowing for continual air movement.
cleanroom standards
| Class | Maximum particles/m3 a | FED STD 209E | |||||
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥1 μm | ≥5 μm | equivalent | |
| ISO 1 | 10b | d | d | d | d | e | |
| ISO 2 | 100 | 24b | 10b | d | d | e | |
| ISO 3 | 1,000 | 237 | 102 | 35b | d | e | Class 1 |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83b | e | Class 10 |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | d,e,f | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | c | c | c | 352,000 | 83,200 | 2,930 | Class 10,000 |
| ISO 8 | c | c | c | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
| ISO 9 | c | c | c | 35,200,000 | 8,320,000 | 293,000 | Room air |
