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If the equipment supplier is located in another country, you must make sure that there are representatives in the territory of the Russian Federation, as well as Russian-speaking employees in the departments with which pre-sale negotiations are held and who are responsible for subsequent technical support (sales department, laboratory, service department )
According to many consumers, the cost of equipment is one of the main criteria that determine its choice. However, in fact, the installation price is not critical. This is due to the fact that, firstly, pharmaceutical products have a high cost, and the income from their sale significantly exceeds the cost of equipment, and secondly, in recent years, the cost of the finished product has been increasing in energy costs, so the energy efficiency of equipment becomes one of the important factors determining his choice. Thus, the above criteria are a reliable guarantee of the suitability and uninterrupted high-quality operation of equipment in modern pharmaceutical production. Production line of sterile ointments and creams. As an example of the modern production of ointments, the production line of sterile ointments and creams, produced by the Russian company NPO Aggregate, is presented. The line includes a melting boiler, sterilizer, homogenizer and pump. The melting boiler (mixer) is equipped with an electric heating element or a steam jacket and is connected to a homogenizing pipe system. The boiler has quick-detachable fluoroplastic scrapers and a multi-blade mixer. The boiler cover is lifted by a special lifting mechanism. Components for preparing the ointment base are loaded into the mixer through the lid. Here the mass is heated and thoroughly mixed. After that, medicinal substances are added to the ointment base. At the bottom of the apparatus there is an outlet pipe through which the mixture is fed into the homogenizer. Here the mixture is homogenized, which returns to the apparatus from above. The finished mixture through the filter, which delays all mechanical impurities, enters the sterilizer, which is also equipped with a steam jacket or electric heating elements. It has thermal insulation, quick-detachable fluoroplastic scrapers and a multi-blade mixer. In the sterilizer under pressure at a given temperature and constant stirring for a certain time, the ointment is sterilized. Product unloading is carried out from below. After which the finished product is pumped to the packaging department.
In this regard, it is preferable equipment for wet grinding and dry matter input systems without dust formation. If the equipment is selected for such a process during which, under a certain set of circumstances or non-observance of the instructions for use and safety, the ignition of substances is not excluded, then the condition for the explosion-proof performance of the production machine or installation must be included in the technical task for the purchase. When choosing equipment, it is necessary to pay attention to the flexibility of the design solution: does it allow to produce a narrow or wide range of products, and is it also possible to change technological parameters in the production of a particular product. The more universal the production line, the less investment will be required when removing one from production and introducing another product range.
The next very important criterion for the selection of equipment is the suitability of the installation for the production of pharmaceutical products. For example, metal parts that come into contact with the product must be made exclusively of high-quality stainless steel, and the seal materials must comply with FDA standards (Food and Drag Administration - United States Food and Drug Administration). Equipment should be convenient for washing and sterilization. It is necessary to pay attention to the modern design of equipment and>not only for aesthetic reasons, but also from a practical point of view. Dimensions of the equipment should allow its installation and operation ^ existing production facilities. Based on its weight, the floor load is calculated, which should not exceed the permissible value. If possible, equipment elements should be pulled aside, easily dismantled, opened or moved apart in order to provide convenient access for its maintenance and cleaning.
An important condition for successful competition in the industrial equipment market is the ability of the manufacturer to make changes to the basic design of the installation at the request of the customer, as well as equip the delivered installation with components ordered by the pharmaceutical company. In other words, the best supplier is one that offers not only machinery and equipment, but also engineering and consulting services.
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Before a pharmaceutical product goes into serial production, it must be obtained in the laboratory and pass a quality check and pharmacological properties. Finished high-quality product obtained on laboratory equipment is easier to reproduce in an industrial environment on an industrial scale equipment of the same series.
Therefore, it is more convenient to deal with those manufacturers who supply equipment of the same series in different standard sizes - from a laboratory to an industrial installation. Thus, the ability to scale the process when using the equipment of one specific supplier is an essential criterion for the selection of pharmaceutical equipment. Sometimes investments even in laboratory equipment make up a considerable amount. Therefore, the presence of an experimental laboratory equipment at the manufacturing plant, where representatives of the pharmaceutical company, accompanied by the manufacturing technologists, can produce trial batches of the product, is of no small importance. This approach to the selection of equipment allows you to make the best choice and avoid mistakes when investing. In addition, the choice of equipment is affected by the availability of warranty obligations of the supplier and the availability of spare parts. Therefore, the manufacturer needs to request information about the cost of spare parts and their approximate service life in order to assess in advance the costs of the enterprise for the operation of the purchased equipment. Indirect confirmation of the reliability and effectiveness of equipment of a particular manufacturer are positive reviews and recommendations from consumers of this equipment. Therefore, before making a purchasing decision, you should ask the supplier for a list of pharmaceutical companies that previously purchased equipment from him, as well as a list of equipment that was supplied to them. When choosing a supplier of equipment, it is necessary to pay attention to its economic situation and internal organization, which are not limited only to current business results. From the point of view of reliability of the subsequent warranty service and the guarantee of providing spare parts, it is preferable to work with suppliers who are not separate enterprises, but are united in one group and have representative offices around the world. The weakening market conditions in one state and the deterioration of the position of one group enterprise, as a rule, do not affect the position of other group enterprises.