Medical-grade filtration, washing and drying three-in-one

The common production process of raw materials for crystallization and drying is as follows: crystallization in a crystallization tank → solid-liquid separation by a centrifuge (or solid-liquid separation by a filter)→ cleaning in a washing tank → vacuum filtration → drying in a double-cone rotary vacuum dryer (or vacuum drying oven)→ manual discharge → crushing by a crusher → screening by a mechanical vibrating screen → mixing by a mixer → manual loading into cylinders. During this process and equipment operation, there were multiple transfers of crystal-containing materials, and the continued use of traditional equipment was subject to certain limitations. The problems exposed by the traditional crystallization and drying process equipment and technology for the production of active pharmaceutical ingredients are:

In the production of crystal-containing materials, there will be multiple processes such as shoveling and turning the material, scooping out the powder, and pressing and grinding the filter cake. This will cause the crystals to be exposed for too long and also lead to cracks in the filter cake, affecting the uniformity of crystal formation and thus the quality of the product.

(2) Due to the limitations of continuing to use traditional equipment, materials need to be transferred multiple times during production, which is prone to cross-contamination and makes it difficult to meet the requirements of full sealing. For pharmaceuticals, food, biological products and other materials that are difficult to meet the regulatory requirements, and for flammable, explosive, toxic or highly toxic materials, there are also potential safety hazards.

(3) The numerous processes and equipment, along with the simple structure of the equipment, make the operation cumbersome and the labor intensity of production extremely high. At the same time, the backwardness of traditional individual equipment makes the cleaning and sterilization of batch change extremely difficult, and it is impossible to ensure its effectiveness.

In conclusion, the biggest problem exposed by the current production equipment and technology of crystalline drying type active pharmaceutical ingredients is the difficulty in meeting GMP requirements: The serious defects such as poor filter cake washing effect, high labor intensity of manual operation, difficulty in material transfer, easy influence and contamination of materials by equipment transmission components and open environment, and difficulty in operation and verification of equipment cleaning and sterilization have a significant impact on the color grade, contamination and visible foreign matter quality indicators of the products. Therefore, in order to solve the above problems, it is particularly important to design a sterile grade flat plate filtration, washing and drying machine.

In order to overcome the problems and deficiencies existing in the production of current crystalline drying type raw material drug production equipment, Wuxi Sunray has carried out a large amount of design and research and development work, and finally successfully developed a new type of aseptic grade flat plate filtration, washing and drying machine (Patent No. The equipment (202220704491.8) can successively complete the entire process of filtration, washing, drying and solid unloading in a closed environment, ensuring that the operation of the unit does not pollute the production environment. The materials in the cylinder are transferred in a closed manner without contamination. Such equipment will be easily selected for drugs approved by the FDA for production and can more easily pass GMP verification.

The working principle of the medical-grade three-in-one filtration, washing and drying

The medical-grade three-in-one filtration, washing and drying equipment integrates multiple unit operations in the post-treatment process of active pharmaceutical ingredients into one device. This equipment can successively complete the entire process of filtration, washing, drying and solid unloading in a closed environment, avoiding product transportation loss and contamination during process conversion. It features a fully enclosed and fully automatic design, making operation convenient. It is highly suitable for the production of fine chemicals, pharmaceuticals and their intermediates, as well as flammable, explosive and highly toxic special chemicals.

The aseptic grade filtration, washing and drying machine developed by Wuxi Shuangrui has been rapidly promoted and applied due to its superior performance of being able to complete filtration, washing, drying, sampling, automatic discharge, as well as cleaning and sterilization in the same container. It has gradually replaced traditional equipment such as centrifuges, vacuum filtration tanks, box-type vacuum dryers and double-cone rotary vacuum dryers in the production of crystalline and drying raw materials for drugs, and has become a new type of equipment for filtration and drying production in the pharmaceutical industry. The overall process equipment solution has effectively addressed the problems exposed by the traditional crystallization and drying type sterile raw material drug production equipment and technology mentioned above.

The entire operation process is completed in a closed, aseptic clean working area, avoiding direct contact between materials and people as well as contamination by the surrounding environment.

(2) Crystallization: Crystallization is an important process operation in the production of sterile active pharmaceutical ingredients. The quality of drug crystal formation not only has a significant impact on the difficulty of subsequent filtration, drying, crushing and packaging operations, but also plays a crucial and decisive role in key quality indicators such as the color grade, dissolution time and stability of the drug.

(3) Filtration: Solid-liquid separation is achieved under pressure or vacuum conditions. After filtration, the filter cake is flat and the solid-liquid separation effect is good.

(4) Washing: A universal cleaning ball is installed on the inner side of the container to evenly distribute the cleaning solution within the container, which is used for material cleaning and container cleaning. Through the stirring of the lifting and lowering stirring blades, the filter cake and the cleaning solution are mixed to thoroughly wash the slurry suspension filter cake.

(5) Drying: The filter cake is gradually loosened layer by layer by the stirring blades. The heating device of the equipment heats the filter cake evenly. Under vacuum conditions, hot gas is used to heat the wet material to accelerate evaporation and achieve the drying purpose.

(6) Unloading: After the material is loosened by scraping, it can be automatically discharged from the discharge port on the side of the cylinder wall by pushing the material through the stirring blades.

(7) The entire set of equipment features simplified processes, prevention of cross-contamination, convenient material interchangeability, enhanced production efficiency, and integration of mechanics and electronics. It can adopt PLC control technology to achieve fully automated operation throughout the filtration and drying processes.

The main components of the medical-grade three-in-one filtration, washing and drying system

The medical-grade three-in-one main unit for filtration, washing and drying is composed of a tank, a base, a drive device, a stirring device, a heating device, a side discharge valve, a support, etc.

(1) Tank body: It is a sealed container with an elliptical head at the top and a flat bottom at the bottom. If drying is required, a jacket or half-tube heating can be used on the cylinder wall. The material of the container is selected based on the properties of the material and the process conditions.

(2) Chassis: Composed of support structure, heating device, filter medium, etc. The detachable chassis is composed of the chassis and the tank independently, connected by hook-shaped bolts. The hydraulic cylinder is used to lift and lower the chassis, thus enabling its installation and disassembly. The lower part of the chassis is equipped with four universal wheels, which facilitate the removal and cleaning of the filter plates.

(3) Filter medium: Generally, filter cloth, metal mesh or sintered plate is used.

(4) Drive unit: Located at the top of the head. There are two types of transmission methods: motor-reducer and hydraulic motor. The rotational speed can be adjusted.

(5) Stirring device: Composed of sealing components, stirring shafts, agitators, etc. The stirring device can achieve variable speed, clockwise and counterclockwise rotational movements, as well as constant-speed upward and downward movements.

According to the form of the stirring blades, they can be classified into straight blade blades and S-shaped blade blades. According to requirements, the cavity inside the blade can be heated by heating medium through the rotary joint at the shaft end to heat the material. The forward rotation achieves the functions of stirring and mixing as well as automatic discharge, while the reverse rotation helps to smooth the surface of the filter cake.

(6) Heating device: The heating of the fully enclosed four-in-one crystallization, filtration, washing and drying integrated machine has the following heating methods:

The cylinder is equipped with half tubes or jackets, which are the main heating components provided

Ii. Heating device inside the chassis.

Iii. Hollow blades connected through the rotary joint at the shaft end.

These heating structures can be used in combination or individually.

(7) Lateral discharge valve: After the valve core is closed, the inner side of the valve body fits with the inner wall of the equipment, which will not affect the stirring on the inner side. The seal of the discharge valve can be either a soft seal or a hard seal. For products with aseptic requirements, an online sterilization device and an online cleaning device can be added inside the discharge valve.

(8) Support: It is a vertical support, made of welded steel structure.

The aseptic grade filtration, washing and drying machine adopts a split structure with a detachable chassis, which is connected to the tank through a C-shaped clamp structure. The bottom of the filtration chassis is equipped with a stainless steel bracket and four polyurethane casters, making it convenient to move the chassis. The tank is supported by three outriggers. The upper part of the outriggers is fixed to the brackets on the side wall of the cylinder with bolts, and the lower part is fixed to the ground. The internal structure of the equipment features smooth transitions without any dead corners.

Performance features of medical-grade filtration, washing and drying in one

(1) Multi-functional integration and continuous operation

The three-in-one equipment completes the processes of stirring, filtration, washing and drying in a single closed device, thus avoiding the mixture of foreign substances and microbial contamination during the material transfer process, and fully ensuring the product quality.

(2) The equipment has a simple structure, which improves the production environment

The three-in-one equipment completes the entire process from feeding to the discharge of the finished product after drying in one device, significantly reducing the total number of required process equipment and achieving the function of one machine equivalent to multiple conventional filtration devices. As the entire operation is carried out in a sealed state, neither liquids, gases nor dust are discharged into the clean room, and there are no factors that cause pollution or harm to the human body.

(3) The process flow is simplified, the floor space is small, and the capital investment is saved

Filtration, washing and drying can be completed in the same system, and the factory space is also maximized. In an era where land is extremely precious, the volume of the required clean factory can be greatly reduced, the basic investment cost is low, and a large amount of capital investment can be saved. This process is more suitable for the needs of large-scale production. It shortens the process, reduces equipment, saves factory space, lowers engineering investment, and at the same time improves product quality, reduces labor intensity, and has good economic and social benefits.

(4) Fully enclosed production process, solvent recovery and utilization

The three-in-one system of filtration, washing and drying is a fully enclosed system. Operating in a closed system can prevent toxic substances from polluting the air and reduce the occurrence of poisoning accidents among operators. The dried products can be mechanically conveyed to weighing, packaging and other sections. The materials and solvents are almost completely recycled, avoiding waste caused by material omission and solvent evaporation.

(5) Clean production, thorough cleaning

The three-in-one filtration, washing and drying system is equipped with a dust collector to collect the dust generated after drying, which can meet the production requirements of clean type. The system is equipped with the functions of automatic spraying and stirring, which can thoroughly clean the filter cake, thereby reducing the amount of sewage discharged and lowering the cost of wastewater treatment.

Improvement of the three-in-one technology for medical-grade filtration, washing and drying

(1) The flat plate type filtration, washing and drying machine can continuously operate the entire process of filtration, washing and drying in the same equipment, with automatic discharge to avoid contamination and meet the requirements of the pharmaceutical production process.

(2) The equipment consists of a tank, a stirring system, a filtration system, a heating and insulation system, and a control system, etc. The equipment is safe, stable and reliable.

(3) The equipment tank adopts a split structure with a detachable chassis, which is connected to the tank through a hydraulic quick-opening mechanism.

(4) The tank wall is equipped with a heating jacket to indirectly heat and dry the materials through heat conduction.

(5) An insulation layer is set on the outer surface of the equipment for heat insulation and to reduce heat loss.

(6) The stirring system is equipped with an S-type internal heating double-blade hollow stirrer, which can thoroughly stir and heat the filter cake, improving the efficiency of washing and drying.

(7) The chassis filter adopts 6 layers of 316L stainless steel sintered mesh.

(8) Through hydraulic transmission, the lifting of the chassis, the hydraulic locking of the chassis, the lifting of the stirring blades, and the discharge switch are achieved.

(9) Set up a main shaft bellows integrity detection system;

(10) Set up a vacuum sampling device. The qualification of the material can be determined after sampling at the sampling port. Sampling can be operated under vacuum conditions, so that the vacuum degree inside the conical cylinder will not be affected throughout the sampling process and the drying process will not be interfered with.

(11) The CIP online cleaning system adopts a design with multiple spray heads, which facilitates the online cleaning of the main unit and auxiliary pipelines, meeting GMP production requirements. The structural design and processing technology of the accessories and connecting pipelines of the CIP online cleaning system must ensure no dead corners, easy cleaning and easy disassembly and assembly.

(12) The mechanical seal and the part of the tank that comes into contact with the material are internally in-situ cleaned by rotating the cleaning ball. The outer sealing liquid cavity of the mechanical seal and both sides of the wear collection cup are equipped with cleaning ports.

(13) The dust vacuum filter is directly connected to the dryer cylinder, allowing for quick replacement of the filter element. It also meets the online cleaning requirements and complies with GMP standards. The pressure transmitter installed on the filter is connected to the automatic control system. Before the filter screen gets clogged, it automatically blows nitrogen back to prevent clogging, ensuring the unobstructed flow of the vacuum pumping pipeline.

(14) The side discharge valve is equipped with an air sweep device with multiple air blowing ports. When the discharge port is closed, external power can blow external air into the air blowing holes to sweep the material residues on the valve plug and the base of the discharge valve, meeting the clean production requirements of GMP and FDA.

(15) The automated temperature control system uses Pt100 platinum resistance as the detection element for temperature detection, which is directly inserted into the cylinder to reflect the vacuum temperature of the material. The temperature detection signal controls the opening and closing of the heat source entering the valve through the temperature regulator to meet the optimal temperature required by the material.

(16) The pressure transmitter adopts PLC control. The strict and effective control system not only ensures the automatic operation of the equipment but also greatly improves the reliability of the equipment operation, thereby effectively guaranteeing the quality of the products.

(17) The control system adopts Siemens PLC and on-site LOP operation. It features a compact human-machine interface, simple operation, convenient maintenance, expandable output, and provides space for equipment upgrades.

On-site photos of the medical-grade filtration, washing and drying three-in-one system

Wuxi Shuangrui is committed to promoting technological innovation in closed-loop circulation dryers and multi-functional filtration, washing and drying machines, and values the full trust given by customers. Intellectual property rights are the common lifeline of Shuangrui Machinery and its customers. At Wuxi Sunray, we adhere to the foundation of our business as honesty and dedication, and maintain a zero-tolerance policy towards infringement. We resolutely crack down on any criminal acts that infringe upon intellectual property rights. This is the supreme responsibility, obligation and commitment of Wuxi Sunray. We must sincerely repay our customers' trust and completely eliminate any infringement.