API dust-free workshop process equipment

The main task of the fermenter in the dust-free workshop of the raw material drug is to complete the cultivation and fermentation. The strains must be cultured on the pharma machinery slope and shake flask, and then gradually transferred to the fermenter through the seed tank and the middle tank. Before inoculation, the cultivation in the tank is required. The liquid is sterilized and cooled to the culture temperature, while using the ...

Text label: API dust-free workshop, design and construction of dust-free workshop, process equipment of dust-free pharmaceutical cleanroom

API dust-free pharmaceutical cleanroom process equipment

The main task of the fermenter in the dust-free workshop of raw materials is to complete the cultivation and fermentation. The bacteria should be cultivated on the laboratory slope and shake flask, and then gradually transferred to the fermenter through the seed tank and the middle tank. The culture medium in the plant is sterilized and cooled to the culture temperature, and the pressure is maintained with sterilized compressed air, and then the seeds are input into the seed tank under aseptic conditions, and then transferred to the seed tank step by step to expand; In the process of inoculation and transplanting, steam sterilization measures should be configured for the pipelines that pass through in advance, including the introduction of steam and the discharge of the remaining air in the original pipeline. The continuous sterilization method is often used to sterilize the culture medium of the large-volume fermenter. After the culture medium is stirred evenly, it is pumped into the continuous sterilizer. After the specified temperature, pressure and residence time, it enters the sterilized In the fermentation tank, its temperature, pressure and residence time should be strictly controlled and verified by sterilization.

Extraction and leaching is the process of mixing and contacting the active ingredient from the liquid phase or solid phase with another liquid phase and re-separating it, so as to transfer the active ingredient. Such equipment requires that the equipment body and the attached pipes are not The material liquid is accumulated and can be cleaned online. The leaching equipment should also be able to discharge all the solid materials to be leached after each batch of operations, and can be cleaned online. The stirring of the crystallizing tank should also be equipped with a suitable shaft seal. The worn end face of the shaft seal may have worn-off particles, which should be controlled by the positive pressure operation of the crystallizing tank and the bearing groove of the wear material, so that such worn-off particles are not mixed into the finished product; The stirring impeller and its combination should be compared and matched according to the requirements of the crystallization process, such as particle size, crystal form, etc. In the process of cooling and crystallization, the selection of the impeller should also be paid attention to to prevent the crystal from forming a crystalline layer on the wall of the vessel. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for API dust-free workshops and laboratories.

APIs are mostly reacted in the reaction tank, and the post-processing needs to remove the filter residue or extract the solution, so the equipment for solid-liquid separation is also a commonly used production equipment, such as centrifuges, three-in-one equipment, filters, etc. , After the crude drug is extracted, filtered and crystallized, it is necessary to remove excess water or solvent to achieve the desired drying degree. Commonly used drying equipment includes vacuum drying oven, rotary dryer, belt dryer, etc. Centrifugation is to use the strong centrifugal force generated by the high-speed rotation of the centrifuge rotor to accelerate the sedimentation speed of the particles in the liquid, and separate the substances with different sedimentation coefficients and buoyancy densities in the sample. Diffusion produces settling runs. The filter equipment that will be used in the production of small batches of APIs are generally bag filters, plate and frame filters, sterilizing filters, filter presses, etc. When using such equipment, the filter medium should be fully considered. Material, pore size, filtration efficiency, filtration area, the sterilization filter produced by sterile APIs should also consider the compatibility of the filter material with the product, the solvent, and the retention capacity of bacteria.

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