Chemical synthetic medicine training workshop
1. concept
Chemical synthesis refers to the industrial production of various chemical raw materials in certain conditions through chemical reactions to obtain products with a certain effect, and then through crystallization, drying and other processes to make it reach the various indicators of the drug API production methods.
2. common chemical synthetic drugs
1. Total synthesis: Most chemical synthetic drugs are made of basic chemical raw materials and chemical products through various chemical reactions, such as sulfa drugs, various antipyretic analgesics
2. Semi-synthetic: Some chemical synthetic drugs are chemically processed by using natural products with certain basic structure as intermediates, such as steroid hormones, semi-synthetic antibiotics, vitamin A, E, etc.
3. Chemical synthesis combined with microbial (enzymatic) synthesis: vitamin C, steroid hormones, amino acids
Characteristics of 3. Chemical Synthetic Medicine Workshop
1. The reaction process is long and the operation is complicated.
2. A large amount of acid, alkali, organic solvent, etc. are generally used in the reaction, so the workshop has higher requirements for fire, explosion, corrosion, virus and burn prevention.
3. Reasonable consideration of material transportation by using potential energy
4, raw material medicine fine baking package post meets GMP requirements
5. Due to the large number of equipment and large pipeline volume, it is necessary to reasonably arrange the operating surface and the dangerous process
4. layout form
1. Single-storey plant: It should be included in Class A and Class B compartments and pop-up layout, so that multi-storey operations can be arranged in one room according to the different requirements of process flow and equipment space.
2. Multi-storey workshop: For chemical synthesis API factories with long process flow and high output, as well as those with special requirements for process and equipment, multi-level workshops can be adopted, but generally no more than four floors, with good arrangements and pop-up windows.
Local multi-layer: it not only takes into account the single-layer layout requirements of explosion-proof production space, but also reduces the occupied space of the workshop and improves the efficiency of space utilization.
5. considerations
1, the support platform adopts steel platform, easy to adjust the equipment, and reserve a certain space for future process improvement plan
2, the use of flammable and explosive raw materials, to control the amount and operating conditions, it is strictly prohibited to store over time.
3. For the room of hydrogenation synthesis reaction, set up corresponding skylight to promote H2 emission and ventilation
4. Reaction tanks and gas vessels equipped for high-pressure safety must adopt specific manufacturing methods to meet the requirements of safe production.
5. Potential safety hazard areas, toxic areas and dangerous areas shall be delimited respectively, and protective measures shall be taken to meet the requirements of safe production.
In the northern region, attention should be paid to antifreeze in winter to avoid safety accidents caused by freezing and cracking of equipment and pipelines.
Related programmes
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Construction of Pharmaceutical Engineering Training Center