In accordance with the requirements of the 'drug production quality management norms', the requirement is aimed at all pharmaceutical machinery, including pharmaceutical workshop some auxiliary facilities, how to digest, according to the requirement of the 'norm' and truly meet the requirements of the 'norm' need pharmaceutical machinery manufacturers and pharmaceutical manufacturers work together, in fact, the centrifuge from pharmaceutical producers application occasions, craft, the physical and chemical properties of the medium is different, also have different requirements for the centrifuge. Selection
1. Choose the suitable model is crucial, for certain products and certain occasions, some models are not appropriate, even in structure design can spend a lot of effort may not achieve the desired effect. Centrifuge users should put forward requirements of specification. That is to say, by the users according to the actual application of the working environment, processing of physical and chemical properties, processing requirements, control, etc. Put forward specific demands of the centrifuge, determine the model together with the manufacturers.
2.
material selection for a particular medium, should choose suitable material to make, in order to meet the above requirements, but also to achieve anticorrosive this basic requirements. These materials is not only a drum metal materials, such as all parts contacting material material should meet the requirements, including seals, fasteners and so on.
material selection is the realization of the anticorrosion performance, cleanliness requirements, in accordance with the separation of material corrosion data, Chemical properties, temperature, concentration, etc. ) , choose suitable material, such as 321, 316 l, etc.
the pipe material, on the occasion of some high cleanliness requirements, should choose the health level and health level fast loading card, to eliminate pipe may bring pollution, also facilitate clean.
3, structural design and surface treatment, when the design should reduce as far as possible, Eliminate) Combined with the surface, in order to eliminate the combination of surface crack of hidden scale and difficult to clean.
welding junction should be continuous, Continuous welding) , the Angle of fillet weld shall be ground to a smooth transition, butt weld should be smooth.
all the sharp corners and must take cover the round the corner, produce a smooth transition of rounded corners, as far as possible eliminate bulge and potholes, eliminate health dead Angle, eliminate effusion, product materials such as blind Angle.
centrifuge when repair, maintenance and repair personnel, tools, spare parts and so on will cause pollution to the aseptic workshop. As a result, the design of the centrifuge should be of simple structure, convenient disassembly, convenient transportation, ensure the rationality and reliability of the product structure.
4, online cleaning
to ensure every batch of products can achieve consistency, prevent the product structure and microbes, germs, such as pollution, set should be considered in the design of cleaning and disinfection, sterilization device ( Users can accept) 。
all surfaces to be easily cleaned, and so not make product contamination or chemical reaction may be produced in the process of production.
in the centrifuge lumen ( When need should be in more than one) Set up multiple cleaning head or the tube, the centrifuge can not open or operation process for cleaning the interior of the centrifuge is not visible surface. Mainly has the following several parts:
a. Drum bottom and bearing parts;
b. Block board surface and turn the drum body surface;
c. Drum cylinder body surface;
d. Flip and feed on the inner surface, the surface of the scraper device such as;
in recent years, the domestic pharmaceutical industry reform, puts forward higher requirements on centrifuge, in accordance with the 'drug production quality management norms' to the requirement of equipment, on the premise of keep the centrifuge separation properties, still must meet the 'drug production quality management norms' of equipment requirements. The specification of the centrifuge design, manufacture, selection, installation requirements mainly includes: design, selection, installation of equipment shall conform to the requirements of the pharmaceutical production, easy cleaning, disinfection or sterilization, facilitate the operation and maintenance, maintenance, and can prevent errors or reduce pollution.
direct contact with drugs of the equipment surface should be smooth, level off, no dead Angle, easy to clean or disinfect, corrosion resistance, doesn't change or adsorption of drugs and drug.
equipment used in lubricant and coolant, etc shall not cause pollution to drugs or container. Design and installation of pipelines should avoid blind Angle, blind pipe. Into the clean room, Area) Personnel shall not make up and wear ornaments, bare hand direct contact with drugs.
used in the production and inspection instruments, meters, measuring tools, instruments, etc. , its applicable range and precision should conform to the requirements of the production and inspection, have obvious signs, qualified and calibrated regularly.
production equipment should have clear status flag, and regular maintenance, maintenance and validation. Equipment installation, repair and maintenance operations shall not affect the quality of the products.
to have special requirements of instruments, meters, instruments should be placed in a special room, and prevent electrostatic, vibration, humidity or other external factors influence the facilities.
in view of the above requirements, when the design must be fully considering the structure type, material selection, function implementation of a series of measures; In manufacturing, with considerable processing capacity and processing means to achieve such as surface finish requirement; In considering the model selection of the actual production process and characteristic of medium and cleanliness requirements, etc. , to select the suitable models; When installation should take into account the ease of maintenance, and centrifuge interface ( Liquid, solid, electricity, etc. ) Reasonable configuration of device.
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