Guangzhong is an important manufacturer of disc separators in China, and many series of separators are widely used in the industries of yeast, starch, rubber, medicine, and biochemistry.
Food/Pharmaceutical Centrifuge GMP Specification
According to the requirements in the GMP specification, relevant requirements are put forward for the equipment, but its requirements are for all pharmaceutical machinery, including some auxiliary facilities of the pharmaceutical plant, how to digest according to the requirements of "standards", and truly meet the "standard" The requirements require the joint efforts of pharmaceutical machinery manufacturers and pharmaceutical manufacturers. In fact, due to the differences in the physical and chemical properties of the centrifuges used by pharmaceutical manufacturers, the physical and chemical properties of the centrifuges, the centrifuges have also brought different requirements. For example: anti-corrosion requirements, explosion-proof requirements, medium temperature, workshop purification levels, and so on. Here are some of the issues involved in GMP applications:
1. Implementation of airtight requirements:
The pharmaceutical centrifuges, whether they are non-sterile or sterile, are pharmaceutical intermediates or finished drugs, and require high environmental requirements in the production process, such as in a sterile workshop. There are 10,000-class, 100,000-class workshops, etc. Good sealing performance can maintain external and internal machine isolation. The solid, liquid, and gas phases in the centrifuge chamber must not cause contamination of the workshop environment. Conversely, the operators and the external environment must not cause any contamination of the materials. Therefore, the pharmaceutical manufacturer should inform the manufacturer of the centrifuge at the time of order and ask for a seal. Manufacturers should improve the design of the centrifuge's hermetic properties and fully embody it at the time of manufacture. In general, the following areas should be considered:
Because the cover can be turned over, it should have reliable sealing measures with the joint surface of the housing. If the sealing structure or material fails to be preserved, it may cause leakage of liquid and gas phases and cause harm to the environment and personnel.
Sealing groove structure, sealing strip corrosion performance, design and selection should fully consider its sealing performance and reliability.
For the installation interface of the feeding pipe, washing pipe, sight glass and other additional devices, there should also be reliable sealing measures.
Bearing position seal:
For the spindle nut, bearing position seal, the previous traditional models in this regard the sealing measures are relatively simple and can only be relatively sealed. Such as the spindle nut, spindle nut and drum joints, generally do not set the seal ring, the centrifuge during the operation of the liquid phase, gas phase penetration, corrosion of the spindle cone surface, even infiltrated the bearing, the bearing damage, thus affecting The normal use of the machine. The upper bearing cap is generally provided with a structure such as a skeleton seal, but a part of the upper bearing cap and the tapered bore of the drum is exposed. The gas phase in the centrifuge cavity may cause corrosion on the exposed surface of the main shaft. In the centrifuges used in the pharmaceutical industry, most of the separated materials contain organic solvents or media such as acids, bases, and salts. Therefore, when ordering equipment, the sealing requirements of these parts should be fully taken into consideration, and dynamic sealing or static sealing structures should be provided to achieve Sealing requirements.
Transmission belt work area seal:
The drive belt of the traditional centrifuge is open type, but a protective cover is set at the motor end, mainly from the perspective of safety, in order to improve the safety of its use, but the environmental pollution caused by the dust generated by friction is not controlled. If it is not feasible to use it in a clean area, it must be sealed against the working area of the belt to prevent external leakage of friction dust.
Other parts (outlet pipe, feed pipe, hopper, etc.): For the external pipe of the centrifuge, such as the feed pipe, the wash pipe, the cleaning pipe, etc., the flange installation method is generally selected to ensure its The sealing performance of the interface, for some occasions with high requirements for cleanliness, the interface should use sanitary quick opening interface device to facilitate cleaning.
2. Implementation of online cleaning requirements In the centrifuge cavity, a cleaning device is provided, and the centrifuge can clean the invisible surface of the centrifuge without opening or running.
Some users, whose main product is the separated solid phase, have a high demand for solid phase materials, even if it is an online cleaning tube.
The dripping liquid phase in the wash hole is also not allowed to enter the solid phase. Therefore, appropriate measures should be taken for the design of the in-line cleaning pipe in order to clean the inside of the pipe.
3, anti-corrosion requirements and surface treatment
The choice of materials is related to the realization of anti-corrosion performance and cleanliness requirements. The pharmaceutical industry should generally use stainless steel structure. Although some external components are not in direct contact with the material, stainless steel is preferred because it is more advantageous to the surface cleaning and cleanroom environment.
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 lining or lining the surface of the material that contacts the material. Apply halar coating.
The pipe used, for some occasions with high requirements for cleanliness, should use hygienic pipes and hygienic quick-install cards to eliminate the pollution that may be caused by pipes. For some structural parts that do not come into direct contact with the material, or only support it, it is also possible to use stainless steel-clad manufacturing. In the structural design, it is as smooth and smooth as possible, with a smooth surface, eliminating dead corners and eliminating blind spots such as effusions and accumulations. All stainless steel surfaces should be polished and polished to provide a smooth surface.
4, gas source
Pneumatic action components of the centrifuge, such as pneumatic scraper, gas-assisted scraper, gas recoil device, etc., whose power source is gas (compressed air or compressed nitrogen), and the gas source is cleaned to ensure that the drug is not contaminated by gas. Pollution.
When the gas source enters the centrifuge, the user should set up an oil-water separator and check it regularly. 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 The moisture in the air enters the cylinder and the control valve. The oil mist generator in the gas distribution device should always be filled with lubricating oil, which can reduce the wear of the pneumatic system components and reduce the working resistance.
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