Issues arisen from the applications in gmp

　　 According to the requirements of GMP standards, it will make the corresponding requirements to equipment. But the requirements are for pharmacy machinery including the accessorial facilities in pharmacy workshops. It is needed that pharmacy machinery makers and pharmacy manufacturers shall work together to really understand the GMP standards and comply with them. In fact, the pharmacy manufacturers apply the centrifuges in various environments and with various techniques and various physical and chemical properties of separating materials. Therefore, it will make different requirements to centrifuges in terms of anti-corrosion, anti-explosion and the cleanness of the workshops. It will discuss some issues arisen from the applications in GMP.
　　 1、 The requirement of leakproofness ：
　　 Centrifuges for pharmacy application makes great demands to their working environment no matter aseptic or non-aseptic, semi-products or final products. In the strictly required environment like aseptic workshop of the class of 10k or 100k, good closeness could effectively isolate the machine chamber inside from outside environment. On the one hand, the solid, liquid and vapour materials inside the centrifuge must not pollute the environment of the workshop. On the other hand, the operators and outside environment cannot contaminate the materials inside the machine. So the pharmacy manufacturers should inform the centrifuge makers the requirements of leakproofness when they order the machines. The machine makers should modify the design in terms of leakproofness. Some parts need to take consideration:
　　 Sealing for lids: For the hinged cover, effective seal between the lid and the case is a must. If the seal is wrong or corrupted, it will make leakage both liquids and vapour damaging the environment and human.
　　 In the flange of the lid a seal will be set. The slot on the flange can fix the seal. The seal is a tube with trapezium section having good sealing performance. The seal materials will be selected according to the requirements of anti-corrosion.
　　 Seals should be set for the joints of the loading tube, cleaning tube and watching lens Sealing for bearings: In the past the sealing was very simple for the nuts and bearings of the shaft in the traditional model machines. No seal was set in the interface between the main shaft nut and basket. During the machine running, some liquids and vapors infiltrate into the joint corrupting the shaft surface even the bearing if they go in. It exerts great impact on the machine working. The upper cover of bearing normally has a frame for sealing. The interface between the bearing cover and the cone of basket is not protected. The vapors inside the machine may corrupt the part of the shaft without sealing. The centrifuges applied to pharmacy mostly process solvents contained menstruum or the medium contained acid or alkali. So it should take account of the performance of sealing for these important parts when ordering the machines.
　　 Enclosure for driving belt assembly: The driving belts in the common model of centrifuges are not covered. Only on the side connected the motor is covered for safety purpose. But it does not take account of the environment, which would be polluted by the dusts produced from the friction of the belts. Therefore, it must enclose the whole area of driving belts to block out the dusts flowing out.
　　 Sealing for others: Drainage tube, feeding tube and outlet cup. The outside connected piping, like feeding pipe, cleaning tube and washing hose, normally are installed with flanges to ensure the closeness. For the high requirement environment, the joints should be used with the sanitation standard joint devices for easily cleaning.
　　 2、 Automatic online cleaning
　　 Set cleaning device inside the machines. It can wash up the chamber, which is not visible while the machine is in operation.
　　 Main products of some users are separated solid-phase material, so requirements for solid-phase materials are rather high. It is not allowed even on-line liquid-phase material in the cleaning hole drops into the solid-phase material. In such cases, adequate measures should be taken to guarantee sufficient washing & cleaning.
　　 3、 Anti-corrosion and surface cleaning
　　 The materials of the machine are importantly related to the anti-corrosion and cleanness. In pharmacy industry, normally stainless steel is required even for some parts, which don't touch the materials to be separated. It is good for cleaning the machines and keeping the workshop clean.
　　 Select the materials of the machine like 304,321,316L and titanium, according to the corrosion data ( chemical properties, temperature and viscosity)
　　 In the environments, which make high demands to cleanness, all piping and joints should be chosen with the sanitation standards to avoid contamination to the environment.
　　 Those modules, which don't directly touch the materials for processing, or only for supporting the machine, can be coated with stainless steel plate.
　　 Try to design and make the surface smooth and flat to avoid dusts accumulated.
　　 All stainless steel surface should be polished to keep it smooth
　　 4、 Gas for pneumatic device
　　 The gas (compressed air or compressed nitrogen) is the power for the pneumatic devices, like pneumatic scraper, pneumatic auxiliary scraper gas recoil device, etc. So the gas or air should be purified to ensure that the medicines are not contaminated by the gas or air.
　　 The user shoule arrange an oil/water separator when gas source enters into the centrifuge,this separator should be frequently checked,especially when air moisture is rather high,The oil/water separator in the gas distributor device should also be frequently checked so as to prevent the water in air from entering into the air cylinder and control valve,Oil fog generator in the gas distributor device should be filled with lubricant oil frequently so as to reduce abrasion of pneumatic parts and reduce work resistance.