If there are problems, a lot of pollutants will be generated. The purpose of GMP is to ensure the establishment of scientific management, and even good quality management is difficult to ensure the quality of drugs. Sealed doors. The production workshop is divided into production areas and control areas according to the quality requirements of each product in the production process, and timely repairs are required. Only by using air purification technology, processes, and inspecting the technical interlayer of the purification space workshop, eliminating biological bacteria, etc., can the workshop be ensured to have no problems during the drug production process, Effective control of these pollutants is necessary to produce high-quality products.
Monthly inspections should be conducted on the periphery of the purification workshop to ensure a strict sterile pharmaceutical production environment, safe pharmaceutical products, and good production processes.
Only in this way can truly qualified drugs be produced. The operation and management system, as well as the color steel plate structure, can achieve a high level of cleanliness in the pharmaceutical production environment. If one link is not well controlled. Suzhou Laidong Company is worth recommending.
A clean area is a room (area) that needs to control dust particles and microbial pollution in the environment. Its building structure, equipment, and use all have the function of preventing the introduction, production, and retention of pollutants in the area. An air lock room is an isolated space with two or more doors located between two or more rooms (such as rooms of different cleanliness levels). The purpose of setting up an air lock room is to control the airflow when personnel or materials enter or exit it. The air lock room can be divided into personnel air lock room and material air lock room.
The basic feature of a biopharmaceutical purification room is that it must control dust particles and microorganisms as environmental objects. The cleanliness of the pharmaceutical production workshop is divided into four levels: local level 100, level 1000, level 10000, and level 30000 under the background of level 100 or level 10000.
The temperature of the clean room is controlled between 18-26 degrees Celsius and relative humidity between 45% and 65% without any requirements. Pollution control in biopharmaceutical clean rooms: pollution source control, dispersal process control, and cross contamination control. The key technology of purification room medicine mainly lies in controlling dust and microorganisms. As pollutants, microorganisms are of utmost importance in the environmental control of purification rooms. The accumulation of pollutants in equipment and pipelines in the clean area of pharmaceutical factories can directly contaminate drugs without affecting cleanliness testing. The cleanliness level is not suitable for characterizing the physical, chemical, radioactive, and biological properties of suspended particles. Not familiar with drug production processes and techniques, not familiar with the causes of pollution and the places where pollutants accumulate, and not proficient in methods and evaluation standards for removing pollutants.
The GMP technology renovation of pharmaceutical factory buildings generally involves the following situations:
Due to subjective misconceptions, the application of clean technology in pollution control is unfavorable, and some pharmaceutical factories have invested heavily in renovation, resulting in no significant improvement in drug quality.
The design, construction, manufacturing and installation of equipment and facilities within the pharmaceutical clean production plant, as well as the quality of raw and auxiliary materials used in production, packaging materials, and poor execution of control procedures for human and material purification facilities, can all affect product quality. The reason for the impact on product quality in construction is due to problems in the process control process, which leave hidden dangers during the installation and construction process. The specific manifestations are as follows:
① The inner wall of the air duct in the purification air conditioning system is not clean, and the connection is not tight
