Design points and layout principles of chemical raw material drug workshop
China is a big country in the production of bulk drugs. In 2017, China's API industry showed a certain warming trend. Among them, the main business of chemical raw material manufacturing reached 499.1 billion yuan, an increase of 14.68% year-on-year, an increase of 6.28 percentage points compared with the previous year. Product quality is a key factor in the API industry. Factors affecting the quality of APIs also include workshop design.
The advantages and disadvantages of the design in the chemical raw material drug workshop are very important for the production of raw material drug manufacturers. The insiders said: "A reasonable process layout can realize the advanced process and equipment, and can be used for workshop production, operation, equipment installation and maintenance, and safety and hygiene. Environmental protection creates a good environment."
There are several characteristics of the chemical raw material workshop: First, the reaction process is complicated, the operation process is more, and the number of equipment is large. Second, a large amount of acid, alkali, organic intermediates and organic solvent are generally used, and the workshop is fireproof, explosion-proof, anti-corrosion, etc. The requirements are higher; third, the number of equipment is large, the amount of pipeline is large, and the operation surface needs to be arranged reasonably.
Fourth, try to use the position to consider the transportation of materials; fifth, fully consider the layout of the dangerous process; sixth, the raw material medicine finishing package (refining, drying, packaging) positions should be in accordance with GMP requirements.
Therefore, there are many places to pay attention to in the design process of chemical raw materials. For example, it is necessary to centrally set a flammable and explosive area, and isolate the area from other areas with an explosion-proof wall, in which a good ventilation/exhaust system and an electrical alarm system are provided. For the reactor in the raw material drug workshop, whether the reaction itself requires reflow, as long as the reaction requires high temperature heating or a large amount of heat release during the reaction, the design of the condensing reflux system should be considered.
In addition, for reactors or gas cylinders with high-voltage safety hazards, safety valve overpressure relief measures should be taken to meet safety requirements. The GMP requirements for the synthesis of the drug substance should also be considered.
So, how do you plan to lay out the workshop? In simple terms, two principles need to be followed: First, the synthetic workshop layout is based on the requirements of the process production requirements, based on the process flow, from the perspective of facilitating production operations and facilitating production management, carefully consider the division of functional areas and equipment. Layout design. Second, the layout of the synthetic workshop should meet the requirements of safety, environmental protection and occupational hygiene.
Specifically, in the first principle, it is necessary to follow the layout of the process, and the vertical and horizontal directions are coordinated to ensure the continuity of the horizontal direction and the vertical direction, to minimize the material transportation route and save energy; the same equipment or similar equipment, similar in nature and The closely-connected equipment is relatively centrally arranged for centralized management and unified operation; the vertical arrangement of the equipment must not only fully consider the personnel console channel, but also the operational space required for equipment maintenance and material transportation.
In addition, some experts suggest that the plant space design should fully consider the operation height of the associated equipment and fittings of the equipment, and also consider the installation and maintenance height of the mixing equipment; the various materials such as public materials and public works should be concentrated accordingly. Arrangement; for the post-cleaning package in the workshop, according to the requirements of GMP, the control area, the clean area and the equipment arranged in this area shall be set according to the different cleanliness requirements of the different dosage forms. Finally, it is necessary to divide the different sections of the workshop according to the production area from the perspective of process production process and production management.
In the second principle, toxic production posts must consider strict isolation and protection measures when laying out in the workshop. Avoid areas where people flow more concentrated, and set buffer areas to prevent accidents from spreading; for flammable and explosive production posts Under conditions that do not seriously affect the process flow, try to arrange them relatively as much as possible, control the area, and set the venting window according to the specifications.
The process of explosion hazard is preferably arranged on the top or one end of the plant, and the safety exit is set according to the requirements of the specification; the set of pressure relief surface should avoid the places where people are concentrated and the main traffic roads; the post using corrosive medium should be strengthened. The exhaust gas is absorbed and the spatial position occupied by the corresponding facility is considered.
It is necessary to make full use of the natural ventilation and natural lighting of the workshop; the noise and heat release should be arranged adjacent to the external wall; the layout of the chemical synthetic raw material medicine workshop must meet the current regulations and regulations on fireproof, explosion-proof, fire-fighting, power distribution and other aspects.
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