Author: Shenzhen Zhongjing Global Purification Technology Co., Ltd.Time:2018-07-26 11:45:26Views:771
Summary The blood product production workshop should include the following production areas: plasma storage area, melt-breaking bag-breaking area (including separation of cryoprecipitate and PCC adsorption separation), separation of crude fractions of plasma protein components, purification of small products and packaging, and immunization Globulin refining and dispensing area, albumin refining and dispensing area, product packaging area. Personnel access to the area should be designed for explosion protection.
The design is divided into three parts: crude (before virus inactivation), refined (after virus inactivation), and three areas. The specific functional rooms in the crude area include protein precipitation reaction chamber, filter press chamber, and ultrafiltration chamber. Chromatography, sterilization filtration chamber, low p H value incubation room (or Pap inactivation), appliance cleaning and sterilization room, weighing preparation room, corresponding dressing, laundry, sanitary ware and logistics buffer room; The specific function room of the district has an ultrafiltration room, a nanofiltration filter room, etc.; the functional room of the distribution area has a bottle compartment, a dispensing room, and a freeze-drying room (if it is a liquid dosage type, the room may not be provided) Inter-bacteria, preparation room, sterilization filter room, corresponding dressing, laundry, sanitary ware and logistics buffer room. The flow of people and logistics channels in the rough area should be independent, and the purification air conditioner should be designed separately. The purification area and the distribution area can share one air conditioner.