Food / Pharmaceutical Centrifuge GMP Specification
1. Implementation of the containment requirement: Seal of the cover: Sealing of the bearing position: Sealing the working area of ​​the belt: 2. The online cleaning requirement is realized in the inner cavity of the centrifuge, and a cleaning device is provided. The centrifuge can clean the invisible surface inside the centrifuge without opening or running. Some users, the main product is the separated solid phase, the requirements for the solid phase are very high, even if the liquid phase dripping from the cleaning hole of the online cleaning tube enters the solid phase, it is not allowed, so the online cleaning tube Appropriate measures should be taken in the design to clean the inside of the tube. 3, anti-corrosion requirements and surface treatment The material is selected to achieve the anti-corrosion performance and cleanliness requirements. The pharmaceutical industry should generally use stainless steel structure. Although some external parts are not in direct contact with the materials, stainless steel is preferred, which is more beneficial to the surface cleaning and clean room environment. For the pipes used, for some occasions with high requirements for cleanliness, sanitary pipes and sanitary-grade quick-loading cards should be used to eliminate the possible pollution caused by the pipes. For some structural parts that are not in direct contact with the material, or are only supported, it is also possible to use a form of stainless steel. In the structural design, the transition is smooth as possible, the surface is flat, the sanitary corner is eliminated, and the dead angles such as liquid accumulation and accumulation are eliminated. All stainless steel surfaces should be polished and polished to a smooth surface. 4, gas source The pneumatic action components of the centrifuge, such as pneumatic scrapers, gas-assisted scrapers, gas recoil devices, etc., whose power source is gas (compressed air or compressed nitrogen), should be purified to ensure that the drugs are not contaminated by gases. Pollution. When the gas source enters the centrifuge, the user should set up a water-oil separator and check it frequently. Especially when the air humidity is high, it should be checked frequently. The oil-water separator in the gas distribution device of the centrifuge should also be checked frequently to avoid the arm. The water in the air enters the cylinder and control valve. The oil mist generator in the gas distribution device should be frequently filled with lubricating oil to reduce the wear of the pneumatic system parts and reduce the working resistance. Inactivated Disposable Virus Sampling Tube
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Whether the pharmaceutical centrifuge is a non-sterile or sterile drug, it is a pharmaceutical intermediate or a finished drug, and its environmental requirements are highly demanded in the production process, such as in a high-grade environment, such as in a sterile workshop. There are workshops of 10,000 and 100,000 grades. The good sealing performance can effectively isolate the outside from the inside of the machine. The solid, liquid and gas phases in the inner cavity of the centrifuge shall not cause pollution to the workshop environment. Conversely, the operator and the external environment may not pollute the materials. Therefore, the pharmaceutical manufacturer should inform the centrifuge manufacturer when ordering and propose a containment request. Manufacturers should improve the sealing performance of centrifuges and fully embody them during manufacturing. They are generally considered in the following areas:
Because the cover can be turned over, the joint surface with the casing should have reliable sealing measures. If the sealing structure or material is used for corrosion failure, it may cause leakage of liquid and gas, causing damage to the environment and personnel.
The anti-corrosion performance of the sealing groove structure and the sealing strip should be fully considered in the design and selection of its sealing performance and reliability.
For the installation interface of the feeding device, washing tube, sight glass and other additional devices, there should also be reliable sealing measures.
For the sealing of the spindle nut and the bearing position, the sealing measures of the conventional conventional models in this respect are relatively simple and can only be relatively sealed. For example, the spindle nut part, the spindle nut and the drum joint surface, generally no sealing ring is provided. The liquid phase and the gas phase infiltrate during the operation of the centrifuge, causing corrosion to the taper surface of the spindle, and even infiltrating into the bearing, causing damage to the bearing, thereby affecting The normal use of the machine. The upper bearing cap is generally provided with a skeleton seal and the like, but a part between the upper bearing cap and the drum cone is exposed, and the gas phase in the inner cavity of the centrifuge may corrode the exposed surface of the spindle. The centrifuges used in the pharmaceutical industry mostly contain organic solvents or acids, alkalis, salts and other media. Therefore, when ordering equipment, the sealing requirements of these parts should be fully taken into account, and dynamic sealing or static sealing structures should be provided to achieve Sealing requirements.
In the traditional centrifuge, the transmission belt is open, but a protective cover is arranged at the motor end, mainly from the safety point of view to improve the safety of use, but the pollution caused by the dust generated by the friction is not controlled. If it is not feasible to use in the clean area, the working area of ​​the belt must be sealed to prevent the leakage of friction dust.
Other parts (exit pipe, feed pipe, discharge hopper, etc.): For external pipes of centrifuges, such as feed pipes, washing pipes, cleaning pipes, etc., flange installation is generally used to ensure that The sealing performance of the interface, for some occasions where the cleanliness is very high, the interface should be a hygienic quick-open interface device for easy cleaning.
According to the corrosion data (chemical properties, temperature, concentration, etc.) of the separated materials, select suitable materials, such as 304, 321 , 316L, titanium, etc., or the surface of the material contacting the material, plastic or rubber A haar coating is applied.