There are many sources of drug pollution. If pharmaceutical equipment does not pay attention to cleaning, purification, and isolation, it will become a factor in polluting drugs. Then, how to prevent and control pharmaceutical equipment? China Pharmaceutical Equipment Factory believes that pharmaceutical equipment companies need to conduct pollution prevention and control in terms of functions, material selection, equipment structure, and equipment verification.
Take the material as an example. GMP has a clear definition that the materials of pharmaceutical equipment cannot affect the nature, purity, quality, etc. of the drug, and the materials used must be safe, discernible and intensive. Pharmaceutical equipment is a device that is in direct contact with medicines. If corrosive materials are used to produce medicines, it will not only affect the efficacy of the medicines, but also cause safety accidents and cause environmental accidents and environmental pollution.
For example, when the silicone seal of the condenser of a small distilled water machine is corroded, it will cause contamination of the distilled water. The solution to this problem is to replace the seal with Teflon and pay attention to the repair and maintenance of the equipment. Similar problems will not occur in the future. Therefore, in the prevention and control of pollution of pharmaceutical equipment, related companies need to make choices of materials.
In general, Pharmaceutical Equipment's materials are divided into metallic materials and non-metallic materials. In the case of metallic materials, stainless steel, titanium and titanium composites with low carbon content should be used as long as they are in contact with drugs or corrosive media and work in humid environments. Experts caution that care should be taken when manufacturing iron-based coatings that are resistant to corrosion, heat, and abrasion. Also, pay attention to the consistency of the materials used in the same part or part.
In the choice of non-metallic materials, the principle is non-toxic, non-polluting, should not be loose or easy to slag, hair loss. If it is used for special purposes, it should also consider the heat resistance, oil resistance, non-adsorption, non-hygroscopic properties of the materials used. It is worth mentioning that the sealing packing and filter material should also pay attention to the hygienic performance requirements to prevent contamination.
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Another example is the structure of the equipment. When the pharmaceutical equipment is exposed to the external environment, it is inevitably disturbed by pollutants such as dust and impurities. Therefore, it is important to remove impurities in the internal and external structures of the equipment, and the requirements are stricter.
A more direct and effective way to solve the problem of equipment structural pollution is to simplify the overall structure and shape, and to comply with GMP standards. It is reported that this can make the relevant structure in the conventional design of the equipment smooth and simple, and it is convenient for the operator to clean and prevent the equipment from dust and dirt.
Structures that are not directly related to production operations should be built as much as possible or in a built-in form. It is reported that the wrap-around structure is a relatively common and simple means in pharmaceutical equipment. It can wrap up complex bodies, bodies, pipelines, etc. to achieve a compact structure.
In addition, some insiders have said that many companies will actually ignore the lubrication work of pharmaceutical equipment, and doing this work can also reduce equipment pollution to a certain extent. However, during the operation, no matter what the circumstances, the lubricant and cleaning agent should not be in contact with the drug, including the possibility of all falling in and infiltrating.
If the above phenomenon is encountered, the equipment manufacturer suggests that two solutions can be adopted. To block the drug; second, to block the lubrication part of the device, so as to ensure that the part does not come into contact with the drug raw materials, intermediates, pharmaceutical ingredients and the like.
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