Dust-free purification workshop for powder injection production
Dust-free purification workshop for powder injection production
Powder injections are generally prepared into sterile powder preparations by aseptic manipulation, filtration, low-temperature drying, sub-packaging and other processes. Before use, they are prepared into a solution or suspension with sterile water for injection and injected into the body; The production process of powder injection often adopts the direct packaging method, and the refined non-...
Text label: Powder injection production purification workshop, powder injection production dust-free workshop, dust-free workshop decoration company
Dust-free purification workshop for powder injection production
Powder injections are generally prepared into sterile powder preparations by aseptic manipulation, filtration, low-temperature drying, sub-packaging and other processes. Before use, they are prepared into a solution or suspension with sterile water for injection and injected into the body; The production process of powder injection often adopts the direct sub-packaging method, and the refined sterile powder is directly sub-packed under aseptic conditions. When necessary, operations such as crushing and sieving shall be performed to obtain sterile powder suitable for injection under aseptic conditions. The processing of ampoules or glass bottles and rubber stoppers shall be carried out according to the requirements of injections, but all shall be sterilized; The packaging and the sealing of the ampoules must be carried out in a highly clean sterile clean room modular according to the aseptic operation method. After the packaging, the vials should be plugged immediately and sealed with an aluminum cap. It should not be replaced with other antibiotics for sub-packaging to prevent cross-contamination; sterilization and foreign body inspection must be strictly sterile for heat-labile varieties.
Preparation of freeze-dried sterile powder The preparation of pre-freeze-drying liquid is basically the same as that of aqueous injection. According to the different molding methods of the final product in the freeze-drying process, the process of freeze-dried powder injection can be divided into tray freeze-drying or vial freezing There are two kinds of drying; the preparation of freeze-dried powder is divided into the treatment process of liquid preparation, filtration, filling, pre-freezing, decompression, sublimation, drying, sealing, capping, etc.; freeze-drying is to freeze the solution that needs to be dried into a solid in advance , and then directly sublime to remove moisture from the frozen state without going through liquid state under low temperature and low pressure conditions; transfer the semi-pressed container to the freeze-drying box in a sterile environment for pre-freezing; after the product is pre-frozen, under negative pressure conditions, Constant pressure and temperature rise, so that solid water sublimates and escapes, usually by repeated freezing and sublimation. Through repeated heating and cooling, the crystal structure of the product is changed from dense to loose, which is conducive to the sublimation of water; after the sublimation is completed, it is re-drying During the process, the temperature continues to rise. The specific temperature is determined according to the properties of the product, such as 0°C or 25°C, and if it is kept for a period of time, the sublimated water vapor or residual water can be further exhausted; The hydraulic rear screw lifting device in the freeze-drying box needs to use a special rubber stopper. After the liquid is dispensed, the rubber stopper is placed on the bottle mouth. Because the lower part of the rubber stopper has a gap, the water can sublime and escape. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for dust-free workshops and purification workshops.
The freeze-drying of the product is carried out in the freeze-drying box. There are several layers of shelves in the freeze-drying box. The heat-conducting liquid can be passed into the shelf, which can freeze or heat the product; The condenser is equipped with a spiral air-conditioning coil. Its working temperature is lower than the temperature of the medicine in the drying clean room modular, and the lowest can reach -60 °C. The vacuum system is to sublimate the frozen ice under vacuum. The selection of the system is based on the volume of exhaust gas and the temperature of the condenser. The pressure under vacuum should be lower than the sublimation temperature of ice under sublimation temperature. The vapor pressure is higher than the vapor pressure of ice at the temperature in the condenser; the vacuum system is mostly composed of one or two primary pumps and a pre-pump in series, and a large-diameter vacuum butterfly valve is installed between the drying chamber and the condenser. A small butterfly valve and a vacuum probe are installed between the condenser and the booster pump, which is convenient for vacuum leak detection of the system; the cold and heat exchange system uses refrigerant or electric heat to cool or warm the heat transfer fluid circulating in the shelf. device to ensure the freezing, sublimation and drying process of the product.
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