Biopharmaceutical Workshop Design Process
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When selecting the process flow of a biopharmaceutical workshop the quality requirements of the drug must first be ensured. Under the premise of satisfying the quality of the drug, the process should be simplified as much as possible, and the production cycle should be shortened. The selection of the process flow should fully reflect the technological advancement and reliability.
At the same time, we must also pay attention to the rich experience accumulated by the owners or other factories in the production; when selecting the process, we should proceed from the aspects of production scale, production methods, construction funds, etc., and adopt international or domestic advanced GMP-compliant production equipment as much as possible to reduce Labor intensity, if necessary, consider automation and linkage integration equipment as much as possible, and consider the possibility of future technological improvement and development when there is no condition.
Investment, scale and technical equipment level will also influence the choice of process. Investing in larger projects, using automation and linkage technology as much as possible, and large, efficient and reliable equipment, for projects with small investment and small production scale. Should pay attention to local conditions, properly take care of the degree of mechanization and technological advancement of the process, and leave room for future development.
The same drug in the biopharmaceutical workshop can be made into different dosage forms and can present different therapeutic effects. Obviously, due to different pharmaceutical dosage forms and different quality requirements, the production process will have large differences, so it is necessary to determine the production according to the product dosage form and quality requirements.
Process flow. Different packaging materials for pharmaceuticals, different processing methods and requirements for packaging materials, and different production processes, such as large-volume injections for plastic bottle packaging, large-volume injections for soft-pack packaging, and large-volume injections for glass bottles, although their clinical The application is basically the same, but the production process is completely different; some raw materials can be prepared according to different raw materials, and the process flow will be very different; the biopharmaceutical workshop determines the processing method of raw materials according to the composition and properties of raw materials.
According to the difference of the salt content of the feed water, the purified water can be prepared by ion exchange method, electrodialysis + ion exchange, reverse osmosis + mixed bed, etc.
For the better quality raw materials, the diluted method can be used, that is, the raw materials Add to all solvents and prepare the required concentration; the biopharmaceutical workshop must determine the process according to the production process specified by the product process specification. Once the product production process specification is approved, it cannot usually be changed.
If it needs to be changed, it must be managed. The department re-approved. Kwang Cleanroom can provide consulting, planning, design, construction and decoration services for biopharmaceutical workshops.
The process flow chart consists of material flow, legend and necessary text description. The main contents include drawing the outer contour of the equipment in a certain proportion and marking the equipment bit number; drawing the equipment materials and water, steam, compressed air, vacuum, and freezing Wait for pipelines and flow directions; draw important control points; draw main valves and piping accessories on equipment and pipelines; necessary textual descriptions, such as waste water, waste gas, semi-finished products, and whereabouts of by-products.
The control points of the self-control instruments on the pipeline and instrument flow chart of the bio-pharmaceutical workshop shall be determined by the design of the process professional and the self-control professional, and shall be drawn by the self-control professional designers.