[Editor's note] Due to the design of the equipment selected, Zui will be reflected in the specific production after the completion of the pharmaceutical factory, so whether the selection is reasonable, whether it meets the characteristics of the company's process production, easy to operate, repair, especially whether the equipment meets the "GMP "Requirements, these requirements are particularly strict. It can be said that the rational selection of equipment will greatly affect the "GMP" certification of pharmaceutical companies and future production and further development.

With the deepening of China's reform and opening up policy and the continuous improvement of the market economy system, the "GMP" requirements for domestic pharmaceutical companies are also continuously strengthened. The "GMP" requirements for pharmaceutical companies include not only hardware such as civil engineering, decoration, process layout, production equipment, and surrounding environment, but also software such as process operation manuals and production management procedures. For the pharmaceutical factory and the design institute, the overall layout is reasonable. The layout of the workshop should avoid the intersection of human logistics, the rationality of the selection of decoration materials, and the rationality of the selection of process production equipment. Here we focus on some specific requirements for pharmaceutical machinery when designing process equipment in pharmaceutical plants.

The following points can be used as the main basis for design selection:

1. The equipment has the relevant national policies and regulations, can meet the requirements of pharmaceutical production, ensure the quality, safety, reliability, easy operation, maintenance and cleaning of the pharmaceutical production.

2. The performance parameters of the equipment are in line with national, industry or enterprise standards, comparable to international advanced pharmaceutical machines, and have obvious technical advantages compared with similar domestic products.

3. Complete technical documents that meet the standards.


Since the design of the pharmaceutical factory is a systematic project, it requires the cross-operation of various professions. As the equipment selection, it is often at the beginning of design. Therefore, it is impossible to take up too much time: the information about the process equipment is often more through the introduction of professional magazines, newspaper articles, or the promotion materials of the sales personnel of the pharmaceutical production enterprises, the recommendation of the pharmaceutical factory personnel, and the designers. Mutual technical exchanges. Therefore, the popularity and credibility of pharmaceutical manufacturers, the evaluation of their product quality and after-sales service, the technical quality of enterprise sales personnel, the production of product samples, user lists, etc., are often an important consideration.


In the selection process, the first consideration is whether the equipment meets the requirements of "GMP", whether the contact with the material is smooth, smooth, without edges, grooves, unbonded materials, easy to clean, and beautiful appearance; Whether the control system is advanced and reasonable, the rationality and safety of the lubrication and sealing device of the equipment, etc. are all relatively macro concepts. More specific requirements, including technical data in the equipment sample, such as external dimensions, utility interface orientation, pipe diameter, usage, pressure, production capacity, weight, base size, equipment floor plan, operating surface, maintenance space Request and so on.


For example, for the aluminum-plastic packaging machine, the first thing to explain is the molding method, the large width of the aluminum foil or PVL substrate, the recommended economical layout of the zui, the cooling water temperature and water quality requirements, and the water, electricity and steam. Quantity and interface orientation, pipe diameter; if vacuum is required, the vacuum requirement should be indicated, or the device has a built-in small vacuum pump, but the pump power and cooling water requirements must be indicated. If there are more detailed texts and graphic materials, it will be of great help for reasonable selection.


Another example is the high-speed tablet press, whose production capacity varies with the film diameter and the particle properties are different; in addition, the power supply configuration of the tablet press requires a sieve machine, a dust remover, a dust collector, and a tablet press computer. The special requirements of the power supply, the size of the control cabinet, the power supply mode of the screen machine and the dust collector, the maintenance space to be reserved, etc.; also includes the height and positioning size of the hopper, the data selection for the equipment, and the particle loading device The matching and positioning has a significant role.


For example, coating machines, one-step granulators, etc., because of the involvement of the exhaust ducts, the size of the inlet and exhaust ducts, materials and board thickness, including whether the primary, middle and high-grade filters are equipped, whether the exhaust has been equipped with dust removal , filter, one-step granulator vent height, size, and vent tube length limit, special requirements for the radius of the tube, etc., need to be detailed.


In addition, such as the water needle washing and sealing linkage line, the size of the single machine and the linkage line, the size of the separation position of the bottle washing area and the potting area, the air volume of the tunnel oven, the position and size of the wet mouth of the bottle washer, etc., these data are indispensable. of. For the lyophilizer, whether to set the internal cleaning system, the number of ampoules or vials for each volume of each slab, the approximate operation time of each batch of lyophilization, etc., although it is approximate data, Great help. As a sample of products provided by pharmaceutical companies, we hope to include specific and detailed technical data content, rather than promotional materials such as advertising. With the continuous development of the domestic pharmaceutical industry, the production of pharmaceutical machines has entered the stage of product development from simple and imitation.


As soon as China will enter the "WTO", the pharmaceutical machine factory will face a large-scale competition from foreign drug machines; upgrade the original products, and develop new products with independent intellectual property rights, which is for domestic drugs. For machine companies, it will be a new topic.


It is hoped that pharmaceutical companies will not only be in the manufacture of equipment, but also in the promotion of technical sample production products, etc., and will be able to pass on new products and new technology information to designers in a timely manner. Through our joint efforts, we will use excellent pharmaceutical products that meet the requirements of "GMP", advanced and reliable, and reasonable prices for pharmaceutical companies. For the development of the entire pharmaceutical industry in China, we will meet the challenge of entering the country and promote the development of the national economy. Provide more and more reliable treatment and health care products, and contribute to the power of every medical person.

Source of information: China Industrial Equipment Network

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