How to Calculate Processing Air Consumption of Machining Center

Biopharmaceutical enterprises have strict air quality requirements and need to meet cleanliness, temperature and humidity, pressure difference, microbial control, air flow direction such as core standards, the specific requirements are as follows:

1. cleanliness level requirements

the biopharmaceutical workshop is divided into different clean grades according to the production process and product characteristics to control the concentration of suspended particles in the air. Common cleanliness levels include:

• class A (100): High-risk operating areas, such as aseptic filling, sub-packaging lines, etc. It is required that the number of particles with a diameter greater than 0.5 & micro;m in the air per cubic foot is not more than 100, and the number of microorganisms is very small, which is close to the sterile state.
• Class B: A clean area adjacent to Class A, used to prepare and store products to be filled or sterile materials. Air cleanliness requirements are also very high, second only to Class A.
• Class C and D non-sterile operation area for pharmaceutical production, such as oral preparations and the production of some biological products. Air cleanliness requirements are relatively low, but still need regular testing and maintenance.

2. temperature and humidity control requirements

the biopharmaceutical workshop should control the appropriate temperature and humidity conditions according to the requirements of the drug production process to ensure the stability of the drug and the comfort of the production environment. Generally, the temperature should be controlled at 18-26°C and the relative humidity should be controlled at 45%-65%.

3. differential pressure control requirements

an appropriate pressure differential should be maintained between areas of different cleanliness levels to prevent contamination and cross-contamination. In general, the pressure difference between clean and unclean areas should not be less than 10 Pa SCS, and the pressure difference between adjacent clean areas of different levels should not be less than 5 Pa SCS. The air pressure inside the workshop is slightly higher than the outside, and the dirty air outside is "pushed" out like a "balloon.

4. microbiological control requirements

biopharmaceutical workshops need to strictly control microorganisms in the air, including plankton bacteria and sedimentation bacteria. Microbial contamination may not only affect the quality and safety of products, but may also pose a threat to patient health. Therefore, it is necessary to regularly monitor the number of dust particles and microorganisms in the air, surface and materials. The number of dust particles is detected by a laser dust particle counter, while the number of microorganisms is monitored by methods such as air sampler and culture medium.

5. air flow direction control requirements

• laminar flow design: In the-level area, the air flows vertically downward like a waterfall (laminar flow), "flushing" the pollutants away to avoid turbulence. The wind speed of the laminar flow hood must be stable, too slow has no effect, and too fast may affect the operation.
• three-stage filtration: The air is first filtered by the initial effect, medium effect and high efficiency (HEPA), and the pollutants are "screened" layer by layer.
• positive pressure control: Prevent external contaminated air from entering by maintaining positive pressure inside the workshop.