The pharmaceutical engineering clean room (area) mainly controls suspended particles and microorganisms. At the same time, the temperature, humidity, pressure difference, illumination, noise and other parameters of the pharmaceutical clean room (area) environment should also be controlled to achieve the strict standards of the aseptptic standard. clean room (area) environment should also be controlled to achieve the strict standards of the aseptic process clean room, meet the air cleanliness required by the GMP specification, and to ensure that the air quality is maintained at a reasonable level. required by the GMP specification, and meet the process requirements of each link of drug production.
GMP is the basic principle of drug production and quality management. It is applicable to the entire process of drug preparation production and the key processes that affect the quality of finished products in the production of drugs. It is applicable to the entire process of drug preparation production and the key processes that affect the quality of finished products in the production of raw materials. Vigorously promoting pharmaceutical GMP is to minimize pollution and cross-contamination in the drug production process and reduce the occurrence of various errors. It is an important measure to improve drug quality.
In the GMP Drug Production Management Specification (revised in 2010), air cleanliness is divided into four areas:
-Class A:high-risk operation area, such as filling area, stopper placement area, container open area and aseptic assembly or Class A:high-risk operation area, such as filling area, stopper placement area, container open area and aseptic assembly or connection operation area, usually using laminar flow operation table (hood) to maintain the environmental state of the area
. -Class B:refers to the background area where high-risk operations such as aseptic preparation and filling are located in the Class A area;&&#8482 lt;
-Class C and Class D:refer to the less important clean operation areas in the production of sterile drugs.
(Class A and Class B areas are the locations for online monitoring of particles and floating bacteria;Class C and Class D areas can use portable particles and floating bacteria as routine monitoring. portable particles and floating bacteria as routine detection tools)
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