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 |