Avoid common mistakes in aseptic production line and reduce the risk of pharmaceutical production

The more important requirement of aseptic production line is that all components of the production line should be kept aseptic reliably, including the connection device and supply system of the production line Only when the aseptic production line is designed and manufactured as a whole, all parts meet the requirements of hygienic design, and the corresponding technical specifications can be guaranteed The author has learned that in the aseptic production line, there will inevitably be some errors, which will bring serious consequences to the production, and also make the aseptic production line unable to meet the use purpose and production requirements In fact, some mistakes in the design and operation of aseptic production line can be effectively avoided For example, to avoid dead angle is a big tenet in pharmaceutical production equipment, but in fact, it is not easy to completely avoid dead angle, and pay attention to the installation of valves Experts said that the valve installation should avoid dead angle as much as possible In addition, it is also necessary to ensure that the sealing film and bellows do not bear large pressure impact When checking the installation of instruments and sensors, the dead angle of sanitation and cleaning should also be avoided Industry insiders also said that the sagging suspension pipeline can also be effectively prevented If there is horizontal laying and in the case of slightly sloped pipeline, water will be accumulated in the sag due to the self weight of the pipeline This droop is usually hard to distinguish with the naked eye This kind of water accumulation can cause the pressure drop in the production pipeline when the equipment is started, which is also a major reason for the fluctuation of tank loading In this regard, if the relevant personnel find that there is enough suspension device and appropriate slope, this kind of error can be effectively avoided, because the appropriate spacing of suspension device can avoid pipe sagging At present, the aseptic production line of pharmaceutical equipment enterprises is used for the production of solvent clean API of aseptic and anti-tumor biological toxic products The production line is equipped with high-quality isolation system, which provides sterility assurance for the core link of pharmaceutical process and controls the impact of product toxicity on personnel and environment In addition, customized design is adopted from ingredients to the core area of aseptic production (three in one, crushing and sub packaging), which conforms to the development trend of pharmaceutical production process From the perspective of layout, the workshop layout strictly complies with the current relevant national regulations and standards Under the conditions of meeting the fire protection requirements, industrial safety, etc., it can ensure that the workshop layout is reasonable and compact in accordance with local conditions According to the production process sequence, the battery limit is clear and orderly, so as to save land as much as possible, save investment and improve economic efficiency In the feeding process, the materials of the production line are transferred in by self purification, weighed in the isolator, and fed by vacuum transmission, and the surplus materials are transferred out by RTP barrel The isolator is equipped with CIP / WIP cleaning function and integrated vaporization hydrogen peroxide function to effectively control the impact of product toxicity on personnel and environment In terms of cleaning and sterilization of packaging materials, the packaging materials are also transferred through the integrated connection, the aluminum barrel is automatically cleaned and sterilized, and the aluminum barrel is automatically transferred to the isolator after sterilization, so as to effectively isolate the inconvenience and docking risk of the traditional laminar flow car In addition, the aluminum barrel can enter and exit in parallel, the ultrasonic cleaning time will be greater than or equal to 3 minutes, and the output speed will be greater than or equal to 1 barrel per minute, and the cleaning time of each aluminum barrel can be adjusted In the aseptic production line, every mistake is a unique mistake, but some mistakes are usually occurred in the design and maintenance, and there is no problem at the beginning, but they can bring huge risk to the whole production process In order to avoid these errors, the relevant enterprises need to consider the design and production, so as to provide customers with more advanced aseptic production line.