Major Characteristics of the API Production Process

Compared with the production of pharmaceutical preparations, the production process of API drugs has its own characteristics. Because the production process of APIs often includes complex chemical and biological changes, and has a relatively complex intermediate control process, by-products are often produced during the production process, which usually requires a purification process. At present, many pharmaceutical companies are developing green chemistry technologies, hoping to help improve production efficiency and reduce costs by incorporating more environmentally friendly methods of green production into the synthesis of APIs and intermediates. Today, let’s take a look at the characteristics of the API production process, right?

(1) The production process of APIs is complex

The production process of APIs includes complex biological, physical and chemical reaction processes. For this reason, multiple unit operations are often required in the production of APIs, including subsequent distillation, extraction, purification, etc., and the technology, equipment and facilities are very complicated. . For example, chemical drugs are generally prepared from chemical raw materials with relatively simple chemical structure through a series of chemical synthesis and physical treatment processes, or from natural products with a certain basic structure known to be prepared through chemical structure modification and physical treatment processes. Multiple synthesis steps. The tandem reaction of green chemistry technology can imitate the multi-step chain reaction in the organism. Yes, the reaction can be effectively carried out in multiple consecutive steps from raw material to product in the same reactor, eliminating the separation step of intermediates, and will not produce Waste.

(2) The production process is highly risky

Because the production of APIs requires a wide range of raw and auxiliary materials, and often requires the use of more organic solvents, many of the raw, auxiliary materials and intermediates are flammable, explosive, and toxic. At the same time, the reaction process is often accompanied by high temperature or high pressure controls. , Due to the flammability and explosiveness of organic solvents, there are often certain safety risks in the operation process. Moreover, the solvents used in the reaction medium, separation and formulation are also related to chemical pollution, and the research of toxic and volatile solvent substitutes is an important research direction of green chemistry technology. Medicilon’s Process Department has always incorporated the concept of “green chemistry” into the process of exploration and design and production processes. In addition to the green chemistry industry, Medicilon’s Process Department has a strict quality research system that can control the genes in APIs. The content of toxic impurities and metal element impurities meets the requirements of regulations and ICH guidelines to help customers complete the project smoothly and safely.

(3) The production process is highly polluting, with more wastes

In the production and synthesis of APIs, with the progress of various side reactions, there is a certain amount of waste water and exhaust gas emissions. The resulting pollutants will not only affect the quality of soil, water, and the ecological environment, but also cause toxicity. Cause certain hazards to the air and operators. At the same time, the raw material drug workshop must introduce a variety of drugs during the production process. These raw materials have different properties, so many pollutants of different properties will be produced after production. In the face of reactions between multiple raw materials drugs, cross-contamination of materials must be controlled during the production process of the raw materials workshop.

(3) The production process requires a higher operating environment

The production process requires measures and areas to prevent contamination and cross-contamination, especially the production of sterile APIs. At the same time, the production of APIs must meet the requirements of GMP and various laws and regulations in order to better enter the market. For the production of APIs, GMP is mainly applicable to a key process that affects the quality of finished products during production, and mainly refers to processes such as refining, drying, and packaging.

(4) Basically adopt intermittent production method;

Intermittent batch production means that in the production process, each unit needs to be tested after the end of production, and the next unit can be entered after the inspection is qualified. The process stages and time corresponding to a batch of products from input to output are highly consistent. Each link is regarded as the final product. Once a product is found to be unqualified in a certain link, all products in the same batch are regarded as the same. The unqualified were selected and transferred for re-inspection and other work.

Green chemistry technology can put continuous reaction technology into process synthesis, and can safely complete some high-risk reactions that cannot be completed by traditional batch reactors. Continuous production means that the company puts raw materials into equipment, processes them continuously in order according to actual technological requirements, and finally makes them into end products for sale. Continuous production relies on modern control methods and reliable and stable technological processes to ensure the consistency of end product quality.

(5) Strict product quality requirements;

For continuous production of APIs, a batch of homogeneous products within the specified limits produced within a certain time interval. Intermittently produced raw materials can be a batch of homogeneous products within the specified limits obtained by final mixing of a certain number of products. The batch number of the intermediate can be consistent with the batch number of the API, or they can be independent of each other.

Quality is an important indicator related to the production of APIs. If the quality of APIs cannot be guaranteed, it will directly affect the production quality of subsequent drugs. Through the analysis of the production process of the API, it is known that if the production quality management of the API is to be done well, it is necessary to check the impurity distribution map, the quality assurance system and the sterile API to ensure that the impurity distribution map of the API is accurate and complete. , To ensure that the quality assurance system can play a positive role, improve the sterility of APIs, and avoid secondary contamination of APIs.

Different types of production equipment and operating processes are very different, and the same reaction equipment is often used for different reactions. With the development of science and technology, automated production facilities and equipment, online detection systems, and process analysis technologies are increasingly used in the production of APIs.