Development and compliance requirements of sanitary and sterile instruments

Development status of sanitary and sterile instruments: The hygiene of production equipment is a crucial link in the pharmaceutical hygiene In recent years, a series of policies and regulations implemented by the state for the production equipment of the pharmaceutical industry have also made many relevant units and personnel engaged in the pharmaceutical and food production, equipment manufacturing and engineering design have a new understanding of the concept of equipment hygiene, and pay more and more attention to it in the food and drug production The role of "Hygienic" and "sterile" and "Hygienic" It is required that the actual Zui originally originated from the food industry (including beverage, dairy products, etc.), and now it has been extended to the pharmaceutical industry, so as to ensure the health and safety of food and drug, and ensure that all elements related to food and drug (including raw materials, auxiliary materials, intermediate products and finished products, etc.) will not pass through the contact appliances, equipment (including production and processing equipment, instruments, valves, etc.) ）Contact and mix with the environment and toxic, harmful and polluting substances or substances that are not suitable for confusion In order to meet these special requirements, there are a series of so-called sanitary requirements for the materials, structure, performance, processing (such as welding, polishing, etc.), cleaning treatment and other aspects of the appliances and equipment and its components that may be in direct contact with food and drugs, such as the requirements for non-toxic and harmless materials, including the selection of different grades of stainless steel according to the requirements of different conditions Material (304L, 316L, 410, 409, 329 ）All kinds of polymer materials, rubber elastomer materials, adhesives, lubricants, measuring fluid materials, thermal isolation materials, external plating materials, etc shall not contain toxic and harmful components, and shall not have leakage or infiltration of toxic and harmful components; in terms of structure, the surface shall be smooth and clean, free of dead corners, not easy to accumulate scale residues, not easy to pollute, and easy to wash (quick opening clamp connection is often used Mouth) and easy to sterilize and disinfect, etc.; strict sealing and isolation are required in terms of anti contamination of bacteria, anti-toxic, harmful and pollutant entering and discharging, high-temperature sterilization and sterilization; certain smoothness and weldability are required in terms of processing; appropriate cleaning agent is required in terms of maintenance, internal and external surfaces are easy to clean, CIP and CIS are easy to clean Aseptics are essentially to ensure that there are no conditions for the presence, growth and entry of toxic, harmful microorganisms and bacteria into appliances and equipment Therefore, in addition to the general sanitary requirements, these instruments and equipment often have the requirements of strict sealing and isolation, easy sterilization and sterilization, high temperature sterilization and sterilization, especially the dead angle of sterilization and sterilization is not allowed on the structure and installation At present, the instrument equipment is generally called sanitary type, less called aseptic type, because the instrument, control valve and other equipment cannot be aseptic, but for the pharmaceutical production occasions with aseptic requirements and the instrument equipment with direct contact with such drugs, in addition to the normal sanitary type requirements, the material and structure must also meet strict sealing isolation It can bear the performance and conditions of strict and full high temperature sterilization or chemical sterilization, and it is not easy to produce dead angle of sterilization during installation and use, so as to truly meet the requirements of asepsis and avoid infection As for the instrument and equipment, there are no special hygienic or aseptic standards in China at present There are two main hygienic standards abroad that can be used for certification: one is "3-A" which is mainly formulated by the American 3-A sanitary standards company Health standards and guidelines for their implementation; another is the "EHEDG guidance document" developed by the European health engineering design organization (EHEDG) These two hygiene standards were originally aimed at the equipment, pipe fittings, components or engineering required by hygiene (including sterility) in the production, processing and packaging process of food (including beverage and dairy products) industry At present, these two standards have also been promoted and applied in the pharmaceutical industry, and gradually launched a health-oriented standard (such as "P3-A standard" in the 3-A standard) for the pharmaceutical industry At the same time, the two standards organizations have also undertaken the health-oriented testing, certification and re inspection services for equipment products and their suppliers with health-oriented requirements around the world, and issued health-oriented certification certificates (such as 3-A certificate and EHEDG certificate) At present, many foreign companies' sanitary instruments, valves and sensors have obtained certificates of this standard Generally speaking, at present, the instrument equipment is generally called sanitary type, less called aseptic type However, for the instrument equipment used in the production of aseptic drugs and in direct contact with aseptic drugs, in addition to the sanitary type requirements, strict sterilization, sealing and isolation and other anti contamination requirements are often emphasized Therefore, generally speaking, the production equipment and occasions required by GMP, especially the instruments in direct contact with drug materials, must be sanitary type If the drug is sterile, it must meet the requirements of sterilization of anti infection bacteria as well as the hygiene requirements Therefore, the general sanitary instrument and equipment may not meet the aseptic requirements, but those with aseptic requirements must be sanitary In addition, sanitary instruments often use stainless steel quick opening clamp interface (but not all), while instruments using stainless steel quick opening clamp interface are not necessarily sanitary These are easy to confuse Domestic instrument and control valve industry should also have a lot of sanitary products, but because our country has not its own sanitary product standards, and there is a lack of relatively planned formal certification agency, their products are still lack of strict product certification Therefore, considering the ratio of performance and price, it is necessary to make a careful and careful evaluation from the aspects of hygienic mechanism, on-site use experience, on-site actual requirements and effects when selecting such products However, it should be noted that when we use sanitary products that have obtained foreign certification (including 3-A, etc.), we still need to pay attention to whether they really meet the requirements of sanitary products in practical application In the process of development of instruments to sanitary and aseptic types, the big difficulty for Zui at present is that many of our suppliers and users lack of understanding of the so-called sanitary and aseptic requirements, lack of real understanding of the relevant standards of foreign countries, at the same time, our country has no own sanitary product standards for the time being, and lack of more formal certification bodies Therefore, in order to overcome the above difficulties, it is necessary to gradually strengthen the relevant publicity and improvement work, so that suppliers and users have a deeper understanding and awareness of the requirements of hygiene and sterility, and pay attention to its important role in the production process of food and drugs At the same time, on the basis of strengthening the propaganda and Research on the health standards abroad, the relevant departments of our country should also study and formulate our own health standards and certification system as soon as possible In recent years, with the deepening of the communication of compliance in the pharmaceutical industry, especially the improvement of the requirements for the quality management of drug production in China (including the release and implementation of the new GMP specification), more and more people are paying attention to the GMP and gamp of foreign countries With a deeper understanding and understanding, more and more attention is paid to the requirements of hygiene and sterility in the selection of instrument equipment, which also promotes the instrument supplier to pay attention to the compliance standards, quality and certification of their relevant products In the pharmaceutical and food industries, both instrument suppliers and users will pay more and more attention to the standards, quality, certification and application of sanitary and sterile products, and reduce the so-called sanitary and sterile products that are unqualified or false.