Food/Pharmaceutical Centrifuge GMP Specification
According to the requirements of the GMP specification, relevant requirements are put forward for the equipment, but the requirements are for all pharmaceutical machinery, including some auxiliary facilities in the pharmaceutical workshop, how to digest according to the requirements of the "standard" and truly meet the "standard" The requirements of pharmaceutical machinery manufacturers and pharmaceutical manufacturers need to work together. In fact, due to the different occasions, processes, and physical and chemical properties of the media in which the centrifuges of pharmaceutical manufacturers are used, they also bring different requirements to the centrifuge. , such as: anti-corrosion requirements, explosion-proof requirements, medium temperature, workshop purification level, etc. The following discusses some of the issues involved in the application of GMP:
1. The realization of airtight requirements:
Whether it is a non-sterile drug or a sterile drug, a pharmaceutical intermediate or a finished drug, the centrifuge for pharmaceutical use puts forward high requirements for the environment in the production process. Under high-level environmental requirements, such as in a sterile workshop, There are 10,000-level, 100,000-level workshops, and good airtight performance can keep the outside and the inside of the machine effectively isolated. The solid, liquid and gas phase in the inner cavity of the centrifuge shall not pollute the workshop environment, and conversely, the operators and the external environment shall not pollute the materials. Therefore, pharmaceutical manufacturers should inform the centrifuge manufacturer when ordering, and put forward airtight requirements. Manufacturers should improve the design of the airtight performance of the centrifuge, and fully reflect it during manufacture, generally focusing on the following parts:
Since the cover is reversible, there should be reliable sealing measures on the joint surface with the casing. If the sealing structure or material fails due to corrosion protection, it may cause leakage of liquid and gas phase, causing harm 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.
There should also be reliable sealing measures for the installation interfaces of additional devices such as feed pipes, washing pipes, and observation mirrors.
Sealing of bearing positions:
For the sealing of the spindle nut and the bearing position, the previous traditional models have relatively simple sealing measures in this regard, and can only achieve relative sealing. For example, the main shaft nut part, the joint surface of the main shaft nut and the drum, generally does not have a sealing ring. During the operation of the centrifuge, the liquid phase and gas phase infiltrate, which will corrode the cone surface of the main shaft, and even penetrate into the bearing, which will damage the bearing and affect the normal use of the machine. The upper bearing cover is generally provided with a skeleton seal and other structures, but a part between the upper bearing cover and the cone hole of the drum is exposed, and the gas phase in the inner cavity of the centrifuge may corrode the exposed surface of the main shaft. For centrifuges used in the pharmaceutical industry, most of the materials separated are organic solvents or media such as acids, alkalis, and salts. Therefore, when ordering equipment, the sealing requirements of these parts should be fully considered, and dynamic sealing or static sealing structures should be set up to achieve sealing requirements.
Sealing of the working area of the drive belt:
The transmission belt of the traditional centrifuge is open, but a protective cover is set at the motor end, mainly from a safety point of view, to improve the safety of its use, but the pollution of the environment caused by friction is not controlled. It is not feasible to use it in a clean area. Therefore, the working area of the drive belt must be sealed to prevent the leakage of friction dust.
Other parts (interface parts such as liquid outlet pipe, feed pipe, discharge hopper, etc.): For the external pipes of the centrifuge, such as the feeding pipe, washing pipe, cleaning pipe and other pipes, the flange installation method is generally used to ensure the The sealing performance of the interface, for some occasions with high requirements on cleanliness, the interface should use a sanitary quick-open interface device to facilitate cleaning.
2. The realization of online cleaning requirements is set in the inner cavity of the centrifuge, and a cleaning device is installed. The centrifuge can clean the invisible surface inside the centrifuge without opening the cover or during operation.
For some users, the main product is the separated solid phase, and the requirements for the solid phase are very high. Even the liquid phase dripping from the
cleaning is not allowed to enter the solid phase. Therefore, the online cleaning tube is not allowed to enter the solid phase. Appropriate measures should be taken in the design of the tube to clean the inside of the tube.
3. Anti-corrosion requirements and surface treatment
Material selection is critical to the realization of 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 material, it is still appropriate to use stainless steel, which is more favorable for surface cleaning and clean workshop environment.
According to the corrosion data of the separated materials (chemical properties, temperature, concentration, etc.), select appropriate materials, such as 304, 321, 316L, titanium and other materials, or lining the surface of the material contacting the material with plastic, rubber or Apply halar coating.
The pipes used, for some occasions with high requirements on cleanliness, should choose sanitary pipes and sanitary quick-loading cards to eliminate the possible pollution caused by the pipes. For some structural parts that are not in direct contact with the material, or just support, the manufacturing form of lined with stainless steel can also be used. In the structural design, the transition is as smooth as possible, the surface is flat, and the dead corners such as hygienic dead ends, liquid accumulation and material accumulation are eliminated. All stainless steel surfaces should be ground and polished to a smooth surface.
4. Air source
The 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), the gas source should be purified to ensure that the medicine is not affected by impurities in the gas Pollution.
When the air source enters the centrifuge, the user should set up an oil-water separator and check it frequently, especially when the air humidity is high, and the oil-water separator in the gas distribution device of the centrifuge should also be checked frequently to avoid arm The moisture in the air enters the cylinder and the control valve. The oil mist generator in the air distribution device should be filled with lubricating oil frequently, which can reduce the wear of the pneumatic system parts and reduce the working resistance.
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