The selection and arrangement of air filters should meet the following requirements:
⑴ Medium-efficiency air filters should be centrally arranged in the positive pressure section of the purified air conditioning;
⑵ High-efficiency or sub-high-efficiency air filters should be installed at the end of the purified air conditioning system;
⑶ Medium-efficiency and high-efficiency air filters should be selected at less than or equal to the rated air volume.
The clean room (area) with large area, high air cleanliness, centralized location and strict requirements for noise reduction and vibration control should adopt a centralized purification air-conditioning system. Conversely, a decentralized purification air-conditioning system can be used.
The air purification system should be installed separately in the following situations:
⑴ One-way flow clean room and non-one-way flow clean room (area)
⑵ High-efficiency air purification system and medium-efficiency air purification system;
⑶ Clean rooms (zones) with different operating shifts or usage hours.
The air purification systems produced in the following should be set up independently, and the air outlets should be separated from the air inlets of other medical air purification systems by a certain distance.
⑴ Penicillin and other highly allergenic drugs;
⑵ β-lactam structural drugs;
⑶ Contraceptive drugs;
⑷ Hormonal drugs;
⑸ Anti-tumor drugs;
⑹ Products of highly toxic microorganisms and spores;
⑺ Radioactive drugs;
⑻ Bacteria (poison) operation area.
The air in the air purification system under the following conditions should not be recycled if cross-contamination cannot be avoided after treatment.
⑴ Crushing, weighing, batching, mixing, material making, tablet pressing, coating, filling and other processes of solid materials;
⑵ The granules of solid oral liquid preparations and the purified air used by the drying equipment of finished products;
⑶ Refining and drying process of API refined with organic solvent;
⑷ Pathogen operation area;
⑸ Radiopharmaceutical production area;
⑹ A production process that produces a large amount of harmful substances and volatile gases during the process.
