Discussion on "contest" between ampoule lamp inspection machine and manual lamp inspection

Small volume injection (commonly known as ampoule water needle) is a drug directly injected into human body, except for sterility, pyrogen free and pH value of the drug In addition to the special requirements for the value and stability, there are also high requirements for the clarity of this kind of drugs If there is a foreign body in the injection, it will cause great harm to the human body If the foreign body is injected into the blood vessel, it can cause serious diseases such as phlebitis and thrombus According to the national pharmacopoeia, "the products shall be inspected one by one and the unqualified products shall be eliminated at the same time before leaving the factory" Therefore, the ampoule water needle manufacturer shall check the clarity of the products in full before leaving the factory (i.e the inspection of visible foreign matters), so as to ensure that the products are qualified for leaving the factory and the health and life safety of the patients 1 The problem caused by artificial light inspection: the visible foreign matter in small volume injection refers to the insoluble substance that exists in the liquid medicine and can be observed visually under the specified conditions In China, the water needle is usually packed in ampoule bottle, and the common types of visible foreign matters are mainly glass chips, fibers, white spots, white blocks, etc 99.5% of the water needle manufacturers have always used manual visual inspection under the light (called artificial light inspection) For artificial light inspection, the Pharmacopoeia also made strict requirements, requiring the inspectors to test their vision at a long distance and a short distance of 4.9 or more, and the illumination of 1000-4000lx There are many imperfections in the actual production of the original method of artificial light inspection to inspect visible foreign matters: (1) the vision requirements of inspectors are high, and not everyone can be competent; (2) the production efficiency is low, and each person checks about 1000-2000 pieces / h (3) the vision of the light inspectors is different, and the basis is different, and there is no unified standard; (4) the light inspectors are prone to fatigue, which is likely to cause false inspection or missing inspection; (5) the ideological mood will also cause missed inspection and wrong inspection, and the sense of responsibility of the light inspectors will also affect the inspection results; (6) there is a certain damage to people's eyes; (7) the light inspection work is a repetitive work, monotonous and boring, and recruitment Work difficulty The quality of drugs is of vital importance If unqualified products enter the market after leaving the factory, it will not only bring harm to patients, but also bring great risks and losses to production enterprises For the above reasons, drug manufacturers and drug regulatory departments are eager to develop an automatic detection device for water needle foreign matters (ampoule lamp inspection machine for short) to replace manual lamp inspection Brief introduction of ampoule lamp inspection machine 2.1 the structure of ampoule lamp inspection machine includes frame, bottle feeding device, rotating disk set on the frame, bottle pressing rotating device corresponding to the rotating disk, brake device, light source detection device, bottle output device and servo system Its technological process: products to be inspected → conveyor belt → bottle feeding and wheel shifting → photoelectricity 2.2 features of ampoule lamp inspection machine (1) the inspection performance is stable and reliable, and it can work continuously, which greatly reduces many unstable and unreliable factors of artificial lamp inspection; (2) online and high-speed inspection of visible foreign matters in the liquid of transparent bottle, which can automatically eliminate unqualified products, improve production efficiency, and the output is not restricted by personnel; (3) continuous inspection with turntable is adopted, compared with step-by-step inspection The efficiency of the testing mechanism is higher; (4) the product quality is effectively controlled, the drug safety is ensured, and the risk of the pharmaceutical enterprise is reduced; (5) the novel and simple structure design makes the broken bottle rate of the machine extremely low; (6) the high-resolution industrial camera is adopted, each image collected by each camera is equivalent to the magnification of the tested object by dozens of times, and the strong light is radiated on the tested object, which is visible The visibility of foreign matters is stronger, so the detection accuracy is much higher than that of artificial light detection; (7) in order to meet the needs of different manufacturers and different drugs, the detection sensitivity of the machine can be adjusted; (8) advanced servo system, photoelectric control, image processing and industrial control computer are used, with high technology integration; (9) real-time control software can carry out real-time analysis and comparison of digital cameras, and Command the coordinated actions of bottle inlet device, continuous rotating disk, bottle outlet device and defective product removal device in a unified way to realize full-automatic operation; (10) strong versatility, 1-20ml The ampoules can be applied to all kinds of ampoules, and it is convenient to change the specifications By changing the bottle in and out pulleys and the top cover of the bottle seat, and adjusting the upper and lower positions of the clamps, the specifications can be changed quickly; (11) it has a variety of fault alarm functions, so that the users can be more assured; (12) it is humanized design, which is more convenient for operation, use and maintenance; (13) the machine is controlled by the touch screen, which can Storage of test data, equipped with printer, can print test data for filing for future reference, meeting GMP requirements; more and more drug manufacturers use automatic lamp inspection equipment, and have a clearer understanding of automatic lamp inspection.