Design of infusion agent production workshop
Infusion agent production workshop design
The production process of the infusion agent production workshop generally includes the preparation of raw and auxiliary materials, concentration and dilution, bottle washing, rough washing, fine washing, etc., membrane cleaning, rubber stopper cleaning and drying, filling, sterilization, Light inspection, packaging and other processes; the general production area of u200bu200blarge infusion includes glass bottle washing, sterilization after potting...
Text label: infusion agent production workshop, production GMP workshop, production purification workshop, purification workshop design
Design of infusion agent production workshop
The production process of the infusion agent production workshop generally includes the preparation of raw and auxiliary materials, concentration and dilution, bottle washing, rough washing, fine washing, etc., membrane cleaning, rubber stopper cleaning and drying, filling, sterilization, Light inspection, packaging and other processes; the general production area of u200bu200blarge infusion includes glass bottle external washing, sterilization after filling and sealing, light inspection, packaging, etc.; D-level clean area includes bottle rough washing and capping of raw and auxiliary materials; liquid dispensing, film The cleaning, sterilization and drying of the plugs are carried out in a C-level environment, and are transferred to the filling area under airtight conditions, while filling, filming, and plugging are all carried out in A-level environments in a B-level environment; composite membranes Soft bags are obtained by direct pressing of sterile materials, and generally do not need a washing process. The production line with its own A-level laminar flow will heat the bag in a C-level environment and then fill it directly; if there is no special requirement, the workshop temperature is usually 18-26 ℃, relative humidity 45%-65%, areas with high cleanliness levels should maintain a positive pressure difference of 5-10Pa compared to areas with low cleanliness levels, and UV lamps need to be installed in each process.
The design of the infusion agent workshop should implement the principle of separation of human flow and logistics, and try to avoid the intersection of human flow and logistics. People enter the general production area, D-level, C-level and A/B-level clean areas through different changing rooms; The logistics in and out of the workshop include the entry route of packaging materials, the entry route of raw and auxiliary materials, the entry route of external materials, and the exit route of finished products; when the workshop is arranged, the production-related functional areas should be close to each other to achieve smooth logistics and short liquid medicine delivery pipelines. , such as material flow, the weighing of raw and auxiliary materials → concentrated preparation → diluted preparation → filling process should be as close as possible; the auxiliary rooms of general infusion production workshops include D-level area tool cleaning and storage room, C-level area tool cleaning and storage room, laboratory test room, bottle washing water preparation room, unqualified product storage area, sanitary ware room, etc.; water for injection is the main component of large infusion, the quality of water is the key to product quality assurance, distilled water machine is its key equipment, and the amount of water produced should be equal to that of the infusion agent. The output should be matched, and the water used for cleaning equipment should be considered; the water for injection system should also be sterilized or sterilized with pure steam. The temperature of the water for injection production post is high and humid, and ventilation needs to be designed. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of infusion agent production GMP workshop, purification workshop and other supporting services.
Preparation is a key process in the production of infusion solutions. The room area is large and a ceiling needs to be installed. The height of the concentrated distribution clean room modular is more than 3.5m, and the height of the thin distribution clean room modular is more than 4m. There must be space for the maintenance and disassembly of the liquid distribution tank; the infusion bottle Generally, linkage equipment is used for cleaning. The rough washing equipment is located in the D-level clean area, and the fine washing equipment is located in the C-level clean area. Since the box-type bottle washer integrates rough washing and fine washing, and the equipment is airtight, it can be used. For cross-regional setting, anti-corrosion and ventilation should be considered in the bottle washing room; filling is a key position in the production of large-scale infusion, the equipment selection is based on the principle of advanced and reliable, the production capacity should be matched with the dilute dispensing tank, and the filling should be completed within 4H; When using a double-door sterilizer, there should be enough space before and after the sterilization equipment to facilitate the push and pull of the mold trolley. Note that the sterilizer should match the batch production.
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