With the transfer of the world's raw material drug production center to China and the implementation of GMP verification in raw material drug factories, a "multifunctional filter, washing and drying machine" that integrates multiple production functions in one device with mechatronics is becoming more and more It has been selected by many raw material pharmaceutical factories in many places. In the early 1990s, we were still at the stage of importing this kind of equipment from abroad, but in the late 1990s and early 21st century, several domestic pharmaceutical machinery companies successively used methods such as surveying and mapping to imitate their own research and development, and imported technology. Dozens of such units have been developed and manufactured, and supplied to more than a dozen domestic raw material pharmaceutical factories. Although the solid-liquid separation and drying after drug crystallization can be completed in the same equipment, due to different manufacturing methods, how to comply with GMP verification In terms of requirements and internal quality management procedures of pharmaceutical factories, especially when the machine is used for the production of sterile drugs, there are still many places to be improved.
Sterile grade multifunctional filter washing and drying machine has been widely adopted by domestic pharmaceutical factories in recent years.
Although the process is the same and the models are similar, but in terms of meeting the requirements of "GMP", there are many differences in the quality that should be possessed. The sterile grade multifunctional filter washing and drying machine developed and produced by Wuxi ZhangHua Machinery, Invention patent number: ZL201721560677.6. Achieved a major breakthrough in chemical equipment technology, broke foreign monopoly, greatly reduced the price of multi-functional filter washing and drying machines, and fully complied with "GMP" requirements
1. ZhangHua mechanical sterile grade multifunctional filter washer dryer stirring blade meets the quality required by GMP
Stirring paddle is the core part of the multi-functional filter, it has the longest contact time with the material (crystal), stirring, washing, crushing,
Stirring blades are used for discharging materials, and the stirring blades used for the production of sterile drugs should have the following two qualities.
1.1 Requirements for the special appearance of the blades In this type of equipment, the blades are generally flat or have palladium nails under the flat. However, when used on sterile-grade products, the paddle should be made into an "S" shape. When viewed from above, the paddle is curved in an "S" shape with a downward slope. It looks like a triangular polyhedron from the front and can be made into 2 paddles. blades or 3 paddles (the number of paddles depends on the size of the tank).
1.2 Requirements for Surface Treatment of Stirring Blades
The mixing paddle of the "three-in-one" multifunctional filter has a special shape of a triangular polyhedron due to its "S" shape. There are many welding seams and many curved surfaces during processing. Therefore, after welding, in addition to normal grinding and mechanical polishing, electrolytic polishing is also required to make Ra≤0.3μm, so as to ensure that the blades will not stick. materials, making complex shapes smooth and smooth.
2. The filter chassis and barrel of ZhangHua mechanical sterile grade multifunctional filter washing and drying machine meet the quality requirements of GMP
2.1 Requirements for the filter disc not to be deformed or torn
Although various manufacturers can use 316L multi-layer sintered mesh plates as filter discs, the specific structure of the chassis is different.
The "three-in-one" filter disc used for sterile products should be sintered together with the overall design of the filter screen, filter plate and chassis according to certain technical requirements. Guarantee no deformation, no tearing, and no leakage of any material during operation. Only mesh, plate, disc sintering
The filter discs together can effectively adapt to the changes of cold and hot working conditions in the tank, ensuring that they will not be deformed under any circumstances, and the filter screen will not protrude when it is vacuum-dried or heated-dried.
That is to say, the material has a certain viscosity and will not deform or tear the filter screen when the paddle rotates.
2.2 Requirements for the opening and locking methods of the chassis
Aseptic grade "three-in-one" equipment, because the whole operation is carried out in the 10,000-class clean area, the cleanliness is high and the sterile conditions are good. Therefore, it is required that the filter chassis can be lifted and lowered smoothly and connected with the main body stably. Therefore, a hydraulic system and a clamp quick-opening structure should be adopted, so that the filter disc and the main body can be opened and locked by the rotating clamp through the hydraulic system. fast and stable
Sure, it saves effort and time.
Reduce the vibration of equipment in the clean area to ensure the cleanliness of the production environment. The equipment used for chemical grade production is often connected by chucks or bolts and nuts on the flange, but this method is not suitable for use in sterile clean areas. Its labor intensity is high, disassembly is troublesome, and cleaning and sterilization Bacteria is inconvenient, so the author thinks that this connection method is not suitable for the production of sterile drugs. The quick-opening clamp-type structure is synchronized with the hydraulic system, and the stable opening and locking of the chassis and body can truly meet the requirements of GMP regulations for equipment.
2.3 Requirements for inner surface treatment of cylinder
The surface treatment of the inner wall of the barrel is the same as that of the propeller. After #400 mechanical polishing, electrolytic polishing Ra≤0.3μm is performed to remove the free iron attached to the inner surface and form a chromium-rich protective layer to increase the corrosion resistance and maintain The surface is smooth and stable without sticking materials.
3. ZhangHua mechanical sterile grade multifunctional filter washer dryer discharge valve meets GMP quality requirements
Automatic discharge of dried materials is one of the main functions of this equipment. Since the discharge valve is in contact with finished drugs, the quality requirements are strict, and the dried materials must be sterile, free of foreign matter, qualified in moisture, and qualified in clarity. Dump valves pose special requirements.
3.1 The valve body and valve core of the discharge valve should be connected with soft seals to ensure airtightness and long service life under high vacuum or positive pressure conditions, without frequent replacement of parts.
On the contrary, metal-to-metal hard connections are hermetic, have a short service life and are prone to leakage.
3.2 The cavity of the discharge valve should be clean and smooth, with an internal arc transition and no material accumulation. A PTFE (polytetrafluoroethylene) bellows sleeve is installed outside the valve stem to make it easier to clean. Metal bellows sleeves are not suitable.
3.3 The cavity and valve core of the discharge valve should have CIP and SIP functions to facilitate the cleaning and verification of the equipment.
3.4 The double-cylinder hydraulic pressure is used to open and close, so that the movement of the valve core is stable and reliable. It is not advisable to use the single-cylinder front-mounted or purely manual opening method under sterile conditions. This method takes up a lot of space and is more affected by human factors when opening.
3.5 The inner surface of the discharge valve is electropolished after #400 mechanical polishing: Ra≤0.3um.
4. The driving part of ZhangHua mechanical sterile grade multifunctional filter washing and drying machine meets the quality required by GMP
The driving part refers to the upper structure of the "three-in-one" equipment, mainly consisting of mechanical seals, reducers, motors, and stirring shafts. The two parts, the reducer and the motor, should be fixed on the cylinder, and only one shaft moves, so as to minimize the impact of the equipment on the environment.
4.1 The two major parts of the drive part: the motor and the reducer should be fixed and installed on the cylinder with a special structure and should not move up and down with the shaft.
Prevent pollution to the environment.
4.2 The motor should be an explosion-proof motor with good performance, and use a frequency converter to control the speed. The reducer should also choose a product with good brand and high quality, which has the characteristics of low noise and small vibration, so as to increase the service life of the equipment.
4.3 For the up and down movement of the stirring shaft, since the lifting speed is not fast, it should have the quality of stable lifting, so it is advisable to choose a small-diameter hydraulic cylinder, and set two hydraulic cylinders on both sides of the shaft to complete the lifting of the shaft synchronously. However, it is not suitable to use a large diameter hydraulic cylinder to lift the motor and reducer at the same time.
The aseptic grade multifunctional filter washing and drying machine has the above-mentioned qualities that meet the requirements of GMP, so as to ensure that the operation of the unit does not pollute the production environment, and the closed transfer of materials in the cylinder is not polluted. Such equipment will be easily selected for FDA Drugs that are approved for manufacture, devices can more easily pass GMP validation.
Continuously improve the internal quality of the unit and catch up with the international advanced level. Wuxi ZhangHua Machinery Co., Ltd. has reached a cooperative partnership with many well-known pharmaceutical companies. The sterile-grade multi-functional filter washing and drying machine developed and produced has passed the test of the market. Strive to create more value for customer brands, welcome to call the consultation hotline, and customize your exclusive models.
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