What are the applications of jacketed reactors in the pharmaceutical industry
Information summary:The jacketed reactor is widely used in the core process of drug production in the pharmaceutical industry due to its ability to control temperature (heating/cooling) through the jacketed chamber, good sealing, and strong material adaptability. It is particularly suitable for reaction scenarios that require strict temperature control and a sealed environment. The specific applications are as follow
The jacketed reactor is widely used in the core process of drug production in the pharmaceutical industry due to its ability to control temperature (heating/cooling) through the jacketed chamber, good sealing, and strong material adaptability. It is particularly suitable for reaction scenarios that require strict temperature control and a sealed environment. The specific applications are as follows:
1、 API synthesis process
Raw materials are the core active ingredients of drugs, and their synthesis involves multiple chemical reactions. The jacketed reactor is a key equipment, mainly used for:
Core chemical reactions: such as acylation, esterification, hydrogenation, condensation, redox reactions, etc. For example, in the synthesis of antibiotics (such as penicillin), it is necessary to control the reaction temperature (± 1 ℃) correctly through a jacket to avoid the generation of by-products; The condensation reaction for the synthesis of antifungal drugs requires slow heating (5-10 ℃/h) and insulation through a jacket to ensure complete reaction.
Crystallization and Purification: Crystallization and purification are often required after the synthesis of raw materials. The jacket can achieve correct control of "temperature rise dissolution gradient cooling crystallization" (such as reducing from 80 ℃ to 20 ℃, cooling rate of 1 ℃/min), ensuring uniform crystal size and purity standards (such as in the crystallization process of anti-tumor raw materials).
Solvent recovery: Some synthetic processes require the recovery of organic solvents such as ethanol and methanol. The jacket can provide heating (such as steam heating) to vaporize the solvent, or cooling (such as cooling water) to condense and reflux the solvent, thereby improving solvent utilization.
2、 Preparation production process
In the production of formulations (such as tablets, injections, oral liquids), jacketed reactors are used for the preparation of key intermediate products to ensure stable formulation quality
Injection concentration/dilution: Injection requires high sterility and purity. The jacketed reaction kettle (mostly made of 316L stainless steel, with polished inner walls to Ra ≤ 0.4 μ m) can be heated (such as 80 ℃ insulation sterilization) or cooled (such as room temperature storage) through the jacket to achieve aseptic preparation of the drug solution and avoid microbial contamination (such as the preparation of vaccines and antibiotic injections).
Preparation of solvents for oral preparations: For the preparation of oral liquids and syrup formulations, the temperature should be controlled through a jacket (such as dissolving excipients at 60-70 ℃), while maintaining a closed environment to prevent dust and impurities from entering, ensuring the clarity and stability of the medication.
Preparation of ointment/gel matrix: The matrix of ointment and gel (such as oily matrix and water-soluble matrix) needs to be melted and mixed at a specific temperature. The jacket can control the temperature correctly (such as 50-60 ℃ for the melting of oily matrix and 80 ℃ for the dissolution of water-soluble matrix), and achieve uniform mixing by stirring (with a stirring paddle in the kettle) to avoid stratification.
3、 Biopharmaceutical Process
Biopharmaceuticals (such as protein drugs and vaccines) have stricter requirements for temperature, pH value, and sterility. The jacketed reactor (often paired with sterile design) is mainly used for:
Post fermentation treatment: When extracting target products (such as recombinant proteins) from biological fermentation broth, they need to be cooled through a jacket (such as reducing the fermentation broth from 37 ℃ to 4 ℃) to prevent enzyme activity and product degradation, in preparation for subsequent purification (such as chromatography).
Enzymatic hydrolysis reaction: In biopharmaceuticals, active ingredients are often obtained through enzymatic hydrolysis (such as protease hydrolysis to prepare peptides). The jacket can correctly control the enzymatic hydrolysis temperature (such as 37-40 ℃, matching the optimal activity temperature of the enzyme) to ensure enzymatic hydrolysis efficiency and product activity (such as the enzymatic hydrolysis process of peptide drugs).
4、 Special drug process adaptation
For some special dosage forms or high-risk drugs, jacketed reactors can be adapted to different scenarios through material and structural optimization:
Highly corrosive drugs: For the synthesis of drugs containing strong acids or bases (such as certain steroid raw materials), a jacket reaction vessel made of titanium or Hastelloy material is used, which is cooled with a jacket to prevent corrosion and drug contamination.
Low temperature reaction requirements: Some drug synthesis requires a low-temperature environment (such as -20 ℃~0 ℃, such as the Grignard reaction of some antiviral drugs), and the jacket can be filled with a low-temperature refrigerant (such as ethylene glycol solution, liquid nitrogen indirect cooling) to achieve a low-temperature closed reaction, avoiding the influence of moisture and oxygen in the air on the reaction.