GMP workshop raw material production process water

GMP stipulates that for the raw materials produced by the fermentation process, since the raw materials used may create conditions for microbial contamination, special attention should be paid to prevent microbial contamination during the production process; in traditional fermentation, water may be used, then the pharmaceutical water used here Measures should be taken to prevent microbial contamination. The raw materials produced by “traditional fermentation” are usually low molecular weight products such as antibiotics, amino acids, microorganisms and sugars; attention should be paid to the activity of water when using the fermentation process to produce APIs. The problem of osmotic pressure, due to the dissolution of inorganic salts of various nutrients, the medium has a certain osmotic pressure, as the concentration of the medium increases, the osmotic pressure increases, the corresponding water activity decreases, and the activity in water In an environment below 0.95, bacteria cannot grow, and below 0.7, mold cannot grow.

The fermentation process should pay attention to the problem of pH and dissolved oxygen. PH and dissolved oxygen are important factors affecting the growth of microorganisms. When cultivating microorganisms in fermenters, it is usually necessary to maintain a certain level of pH and dissolved oxygen; in the production process of traditional Chinese medicine preparations, regardless of utensils, The selection, extraction and preparation of medicinal materials are inseparable from water. The use of water in the production of traditional Chinese medicine preparations is very large, but water is also one of the sources of contamination of the preparations. Therefore, the quality of the pharmaceutical process water is problematic, and the quality of the medicine cannot be guaranteed; The quality standard of process water for washing, infiltration and extraction shall not be lower than the drinking water standard; the Chinese herbal medicines after mobile washing and sorting shall be used, the used water shall not be used for washing other medicinal materials, and different Chinese medicinal materials shall not be washed in the same container. To extract the active ingredients and effective parts of traditional Chinese medicines, appropriate process routes should be selected, which should be based on the physical and chemical properties of the active ingredients or effective parts, pharmacological effects, formulation dosage forms, combined with clinical requirements, production feasibility and production equipment. To design a reasonable process route; in the extraction solvent of traditional Chinese medicine, the amount of water is large, Zhongjing Global Purification can provide consulting services, consulting, design, quotation, construction, decoration and other supporting services for the GMP workshop.

Purified water for the extraction process of aseptic traditional Chinese medicine preparations should be purified water. Note that the extraction process is not the preparation process. The water used for the preparation of sterile traditional Chinese medicine preparations must be high-quality water for injection; the initial washing of oral preparation packaging containers can be The use of drinking water, but the subsequent cleaning water should meet the quality standards of purified water; in the oral preparation production process, the initial washing of equipment and utensils that directly contact the medicine can use drinking water, but the final cleaning water should meet the quality standards of purified water.