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pharmaceutical plant
The country has clear regulatory requirements for drug production (GMP), and general drug production plants are divided into raw materials, sterile dr
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product overview
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Particle diameter
Cleanliness level
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static state | dynamics | ||
| ≥0.5μm | ≥0.5μm | ≥0.5μm | ≥0.5μm | |
| A-level | 3520 | 20 | 3520 | 20 |
| Grade B | 3520 | 29 | 352000 | 2900 |
| Grade C | 352000 | 2900 | 3520000 | 29000 |
| Level D | 3520000 | 29000 | Not regulated | Not regulated |
2. When confirming the level, a portable dust particle counter with a shorter sampling tube should be used to avoid settling ≥ 5.0um dust particles in the long sampling tube of the remote sampling system. In a unidirectional flow system, an isokinetic sampling head should be used.
3. Testing can be conducted during routine operations and simulated filling of the culture medium to demonstrate dynamic performance, but the simulation test of the culture medium requires dynamic testing under the "worst-case scenario".
◎ Common air conditioning systems in pharmaceutical factories
The construction of pharmaceutical factories is gradually improving, and the building functions are also gradually improving, so the area is often relatively large, and the required cold and heat are often large.
The commonly used systems are water-cooled chillers and steam systems. This system provides stable heating and cooling, and has relatively high energy efficiency. Steam can also be used to meet the reheating requirements during summer dehumidification. Such as solid preparation workshop, capsule production workshop, freeze-drying powder injection workshop, etc. When the humidity requirement in the workshop is relatively high, a wheel dehumidification system needs to be used.
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