Material requirements and design details of pharmaceutical machinery
Jul 06, 2020
Material requirements and design details of pharmaceutical machinery
Introduction:
We believe that we should all know GMP equipment. The materials of pharmaceutical machinery that are in direct contact with drugs or required process banks' credit risk management should be non-toxic, corrosion-resistant and not fall off, and do not react or adsorb with the produced drugs or the required process media. The pharmaceutical homogenizer produced by Wuxi JKE emulsifying machine is made of 316L stainless steel, which fully conforms to the GMP health standard of pharmaceutical machinery. The products sell well in the pharmaceutical industry market at home and abroad.
Material requirements
Medical homogenizer material requires that the material contact part should be stainless steel AISI 316L, and the carbon content should be less than 0.02%. When welding at 450 ~ 850 ° C, carbon and chromium in stainless steel can form high chromium carbide and lead to local chromium depletion, thus reducing the corrosion resistance of steel. Therefore, stainless steel with low carbon content should be used as far as possible. Stainless steel is characterized by the formation of a thin and strong, fine and stable rich mark oxide film (protective film) to prevent the continuous penetration and oxidation of oxygen atoms, thus obtaining corrosion resistance. If the film is damaged, oxygen atoms in air or liquid will continue to penetrate into the metal, iron atoms will continue to separate out and form loose iron oxide, and the surface will continue to rust.
EPDM (ethylene propylene diene monomer), Viton (fluororubber), NBR (nitrile rubber), PTFE (polytetrafluoroethylene) and kal-rez (perfluoroelasticity rubber) are all sealing materials meeting the food grade requirements of FDA. EPDM has strong high temperature resistance, which can be used at 120 ° C for a long time and intermittently at 130 ~ 150 ° C; it has good steam resistance, and the performance of superheated steam resistance is better than that of hot water resistance, which is very suitable for SIP conditions; its corrosion resistance is excellent, and it has very good resistance to acids, alkalis and detergents used for CIP cleaning. Viton was first produced by DuPont in 1956. It has high temperature resistance (170 ° C at FDA level) and chemical corrosion resistance. NBR has excellent oil resistance, but the temperature resistance can only reach 100 ° C. PTFE has excellent corrosion resistance, insulation, high and low temperature resistance, self-lubricating, non stick and atmospheric aging resistance, but its elasticity is very poor, so it is rarely used in the pump. Kalrez can almost meet the characteristics and high temperature requirements of different materials in the health industry, and the maximum working temperature is 250 ° C.
Food grade sealing material
In the process of centrifugal pump processing, the mechanical seal materials conforming to food grade include silicon carbide / silicon carbide, tungsten carbide / tungsten carbide, stainless steel / special carbon; the mechanical seal materials conforming to medical grade include silicon carbide / silicon carbide and tungsten carbide / tungsten carbide. Any mechanical seal with lubricant does not belong to hygienic design. Even if the lubricant is food grade, it should not be added because its concept has deviated from the design concept of sanitary pump.
About stamping
Stamping refers to the forming process of stainless steel plate or profile by applying external force by press and die to produce plastic deformation or separation, so as to obtain the required shape and size of the workpiece (stamping part); forging refers to the processing process in which stainless steel is applied with pressure and forms the required shape through plastic deformation, This force is achieved by the use of hammers or pressure, and the forging process creates a dense granular structure and improves the physical properties of stainless steel. Medium pressure and forging belong to plastic processing, collectively known as forging. Forging parts have higher strength, inner particles are more compact, there is no porous and redundant space, less inclusions or other impurities, its surface smoothness is higher, and it is easier to meet the pharmaceutical requirements for surface roughness of sterile pump. In this way, the medical homogenizer produced has high quality and good quality.
