Technical points that should be paid attention to in the pharmaceutical industry
As a solid and liquid separation equipment, experimental centrifuges are widely used in the chemical, petroleum, food, pharmaceutical, mineral processing, coal, water treatment and shipbuilding sectors. They are particularly widely used in the pharmaceutical industry and are one of the main processing equipment for pharmaceutical manufacturers. one. However, due to the different occasions, processes, chemical properties, and physical properties of the media used by pharmaceutical manufacturers, there are also various requirements for the sealing requirements, explosion-proof, etc. of the centrifuge. This article starts from the basic requirements of the centrifuge in the pharmaceutical industry. Set out, discuss the various design requirements of the centrifuge to ensure the reliability, repeatability, consistency, and safety of the centrifuge in the production process.
1. Model selection It is very important to choose suitable models. For some specific products and special occasions, some models are not suitable. Even if a lot of effort is spent on structural design, the expected results may not be achieved. You need to choose the corresponding centrifuge according to your required speed, centrifugal force, capacity, temperature control, these key issues, and the centrifuge user should put forward the specifications of the centrifuge requirements. That is to say, the user puts forward specific requirements for the centrifuge according to the actual working environment, the physical and chemical properties of the processing medium, processing requirements, control, etc., and determines the model together with the manufacturer.
2. Material selection For specific media, suitable materials should be selected to meet the above requirements, and at the same time to achieve the basic requirements of anti-corrosion. These materials are not only metal materials such as drums, but all parts and materials that contact the materials should meet this requirement, including seals, fasteners, and so on. The selection of materials is critical to the realization of the anti-corrosion performance and cleanliness requirements. According to the corrosion data of the separated materials (chemical properties, temperature, concentration, etc.), select appropriate materials, such as 321, 316L, and other materials. For the pipes used, sanitary pipes and sanitary quick-installation cards should be selected for some occasions that require high cleanliness to eliminate possible pollution from the pipes and facilitate cleaning.
3. Structural design and surface treatment. During the design, the joint surface should be reduced (eliminated) as much as possible to eliminate the hidden dirt caused by the joint surface gap and it is difficult to clean. The welding joint should be continuous (uninterrupted welding), the fillet weld should be ground into a smooth transition fillet, and the butt weld should be ground flat. All sharp corners and corners must be rounded to produce a smooth transition fillet, eliminate protrusions and pits as much as possible, eliminate sanitary corners, and eliminate dead corners such as liquid accumulation and material accumulation. When the centrifuge is overhauled, maintenance personnel, tools, spare parts, etc. will cause pollution to the aseptic workshop. Therefore, the design of the centrifuge should be simple in structure, easy to disassemble, and convenient to transport to ensure the rationality and reliability of the product structure.
4. On-line cleaning ensures that each batch of products can achieve consistency, and prevents the product's own structure, microorganisms, germs, etc. from being contaminated. In the design, cleaning, disinfection, and sterilization devices should be considered (a user-acceptable solution). All surfaces need to be easily cleaned, and the product does not cause pollution or chemical reactions during the production process. Multiple cleaning heads or cleaning tubes are set in the inner cavity of the centrifuge (should be in multiple locations when necessary), and the centrifuge can clean the invisible surface inside the centrifuge without opening the cover or during operation. The key points are the following parts: a bottom surface of the rotating drum and bearing seat; b surface of the liquid blocking plate and outer surface of the rotating drum; c inner surface of the rotating drum; The inner surface.
5. Whether a closed pharmaceutical centrifuge is a non-sterile drug or a sterile drug, a drug intermediate or a finished drug, the production process of the centrifuge puts high demands on the environment. Under high-level environmental requirements, such as in aseptic workshops, there are aseptic workshops such as 10,000 and 100,000 grades. Good airtight performance can keep the outside and the inside of the machine effectively isolated. The solid, liquid, and liquid in the inner cavity of the centrifuge must not pollute the workshop environment; conversely, the operators and the external environment must not pollute the materials. Therefore, the pharmaceutical manufacturer should inform the centrifuge manufacturer when placing an order and put forward airtight requirements