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—— SIMPOR PHARMA
—— Nasir
—— IATEC,Argentina
—— Mohammed Saad
1. The air velocity of the air supply outlet in the dressing room and operation room of the purification room is more than 0.3m/s, the air velocity of the air shower room is more than 15m/s, the static pressure difference between the operation room and the environment of the purification room is more than 5Pa, and the noise of the system is less than 60dB.
2. The level 2 (P2) aseptic room is level 10.000 and local level 100 in accordance with the current general U.S. Federal 209E standard.
3. The secondary sterile room includes high, medium and primary filtration systems, small central air-conditioning system, laminar air supply and good return air. The locker rooms and air showers utilize an automatic human sensor system.
4. Tertiary (P3) aseptic laboratory in addition to the characteristics of the secondary aseptic room, but also specifically set up electronic interlocking door, transfer window and door interlocking, epoxy resin self-leveling floor and water disinfection system. Self-leveling floor and water disinfection facilities.
5. Configured with secondary biological safety cabinets. The laboratory and rearing room are negative pressure spaces. The relative pressure in the laboratory is -30Pa~-40maza0d; the relative pressure in the buffer room of the clean room is -15Pa~-20Pa.