In the production process of raw materials, both sterile drugs and non-sterile drugs will encounter the transfer of materials (crystals) during the production process. The common production process is: crystallization→filtration→washing→filtration→drying, etc. Process operation. In the past, the old process used in the production of raw materials is: crystallization tank crystallization → crystal filter or centrifuge for solid-liquid separation → detergent cleaning crystals → vacuum filtration → manual discharge → packing, covered with silk bags Drying in a vacuum drying oven (or double-cone drying) → manual discharge → loading raw material barrels.
Among them, during the transfer process of materials (crystals), there will be cracks when the crystal filter is turned over with a spatula or the crystal filter cake is crushed. , The crystal exposure time is long, there are many artificial pollution factors, and at the same time the labor intensity is high. This old process has been difficult to meet the requirements of GMP for pharmaceutical production.
The "three-in-one" (filtering, washing, drying) multi-functional equipment developed by Wuxi ZhangHua Machinery integrates solid-liquid separation of crystals, washing and filtering, and low-temperature vacuum drying. The above-mentioned process operations are completed in a sealed container, thereby effectively To prevent man-made pollution and ensure the internal quality of medicines, the process flow is: raw material medicine crystallization tank crystallization → three-in-one multi-functional filter (filtering-washing-drying)-automatic discharge. This new operation has the characteristics of simple process, sealed operation, convenient material conversion, high production efficiency and good product quality.
The entire production process from the feeding of the crystalline solid-liquid suspension to the automatic discharge of raw materials after drying is completed in one container, which reduces the total number of raw material drug production equipment, reduces investment costs, and reduces the area of the plant. Since the "three-in-one" equipment has the above advantages, it has been gradually adopted by raw material drug manufacturers.
GMP sterile API production "Three-in-one" multifunctional equipment of filtration, washing and drying Working principle
The "three-in-one" equipment separates the crystallized solid-liquid mixture in a closed container using the pressure difference between the front and back of the filter cake as the driving force, and completes filtration→cleaning→refiltering→rewashing→filtering in the same device Or pressure filtration→drying and other processes. Therefore, whether it is initial filtration or re-filtration after cleaning, it is filter cake filtration, that is, under the action of a pressure difference as the driving force, the solid-liquid mixed suspension of the crystallized crystal and the liquid passes through the porous sintered mesh. Plate, so that the crystals (solid particles) are intercepted on the filter medium, and the mother liquor (liquid) is separated through the medium.
GMP sterile API production "Three-in-one" multifunctional equipment for filtration, washing and drying Main features
1.The "three-in-one" equipment completes the stirring, filtering, washing, drying and other processes in the same airtight equipment, thus avoiding the mixing of foreign matter and microbial contamination during the material transfer process, so that the product quality is fully guaranteed.
2.Automatic control, convenient operation, reduced labor intensity, more stable process control
The "three-in-one" equipment can automatically carry out crystal stirring, filtering, cleaning of filter cake, crushing cracks and cracks, drying of materials and automatic discharge of materials, etc. All operations are controlled by hydraulic pressure to achieve stable operation.
3. With in-place cleaning and in-place sterilization functions
All parts in contact with materials can be fully automatic in-place cleaning, including the body, pipes, pipe joints, discharge valves, etc. After automatic cleaning, in-place sterilization can be carried out without moving or disassembling the parts , It is convenient to do a good job in the cleaning verification of equipment and the sterilization verification of air Jin.
4. The equipment structure is simple and the production environment can be improved
The "three-in-one" equipment completes the entire process from the feeding of materials to the discharge of finished products after drying, and the total number of required process equipment is greatly reduced, playing the role of one or more conventional filtering equipment. Since the whole operation is carried out in a sealed state, neither liquid, gas nor dust is discharged in the clean room, and there is no pollution or harmful factors to the human body, thereby reducing the area of the clean area and reducing the total investment cost of the project.
5. Meet the requirements of GMP for the production equipment of raw materials
In the same equipment, unit operations such as stirring, filtration, paint washing, crushing, dehydration, drying and automatic discharge of materials are completed, which reduces and avoids the possible pollution of the environment to the materials, reduces the exposure time of the materials, and ensures the inherent quality of the product. , so that this type of equipment meets the requirements of GMP.
GMP sterile raw material drug production "three-in-one" multifunctional equipment "five major" functions of filtration, washing and drying
1. Stirring and filtering function
The crystallized material (solid-liquid suspension) in the crystallization tank is stirred evenly, and then filtered to separate the crystal from the mother liquor.
2.Filter cake cleaning and filtering function
Also known as filter cake rinsing or replacement cleaning, for easy-to-clean materials, the filter cake layer of the crystal can be washed and filtered without turning over the crystal filter cake layer; for materials that are difficult to clean, the filter cake layer of the crystal can be stirred and washed with a washing machine Replacement cleaning and filtering of the agent can be done once or several times until the cleaning is clean and the process requirements are met.
3. Dehydration extension function
The filter cake is crushed to remove the cracks in the filter cake, to overcome the open circuit phenomenon in the filtration, and to use the pressure or vacuum method to make the filtration go smoothly and the solid-liquid separation is clear.
4. Drying and discharging function
After the low-temperature vacuum drying reaches the drying standard index, the material can be automatically discharged. When vacuum drying, the vacuum can be drawn from the top of the tank, or from the bottom of the filter plate of the tank, and at the same time, the constant temperature hot water is passed through the jacket of the tank, the stirring shaft, and the paddle to heat the material, so as to achieve the purpose of drying. After drying, open the stirring valve and the discharge valve for automatic discharge.
5. CIP and SIP function
After the process operation is completed, the entire cylinder body and discharge valve are cleaned in place (rotary spray balls are installed inside) in the cylinder body and the discharge valve cavity, and then sterilized by steam to complete the CIP and SIP function process .
The "three-in-one" multi-functional equipment produced by Wuxi ZhangHua Machinery Co., Ltd. absorbs the most advanced technology and makes bold innovations, integrates the world's advanced clean equipment manufacturing technology, and focuses on the structure of sterile products Therefore, it is especially suitable for the preparation of sterile raw materials.