Investigation on the current situation of the hott

2022-09-21
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The author has a specific understanding of the production technology, equipment, testing and management level of some packaging machinery, pharmaceutical packaging materials and containers in the United States. At the same time, he also sees that there is a large gap between similar products and enterprises in China. Here are some views on the following aspects

the level of packaging automation needs to be improved

speed up the upgrading of plastic granulator technology. The hoppmann company we investigated is a member of the American Packaging Machinery Manufacturing Association. The equipment they designed and manufactured can slowly lift containers, covers and objects of various shapes and structures into a disc with ingenious rolling tracks and solid rotation, and the arrangement state and direction are consistent, and then transported to the next packaging program. The equipment is cleverly designed and practical. According to the needs of customers, the factory can also produce a complete set of filling and packaging production lines

in China, this part of packaging work, especially the arrangement and assembly of more complex packaging items, is basically manual operation. Many operators can not guarantee the unity and stability of packaging, but also cause pollution to the packaged products. Improving the automation level and quality level of packaging is a very important link for modern pharmaceutical enterprises to implement GMP norms

there is a big gap in filling equipment

another packaging machinery company investigated in China is Cozzoli machinery company. We are most interested in the company's eyedrop filling and packaging line. The eye drops container they produce is composed of three parts: high-quality plastic bottle, middle bolt (drip nozzle) and bottle cap. The filling line can automatically complete the filling of liquid medicine, corking, capping, capping and other processes

most plastic eye drops bottles in our country are of poor quality. The processing of the container is rough, and the seam line, bottle mouth and bottle cap burr and flash are serious; The name, content and usage of the drug are unclear; The bottle mouth is integrated with the bottle body, and the bottle mouth needs to be cut when using, so the dripping amount cannot be controlled. In short, it is impossible to ensure the safety and convenience of patients. The filling equipment of eye drops matched with backward containers is also very simple and primitive. There is a big gap in the material, processing, loading control and automation level of the equipment, which needs to be improved

the quality of glass products has not been paid enough attention to.

during our stay in the United States, we visited Lawson mardon Wheaton, which is well-known in domestic peers for the production of medicinal glass, plastic containers and their equipment, and also visited three production plants and a laboratory of the company

our general impression of Witton is that they maintain the world leading level in the production technology, equipment and product quality of molded glass bottles, medical glass tubes and medical plastic bottles

compared with Witton company of the United States, China still has a considerable gap in the production and technology of pharmaceutical glass products, plus 1 fixed load equipment, as well as the quality and packaging of products. From the formula of glass, the method, equipment and precision control of batching, the melting of glass, the refractory of kiln and the control of melting process parameters to the equipment and process condition control of tube drawing, the quality inspection of glass tubes, the post-treatment of glass tubes (blowing, fine cutting, round mouth, etc.), and the packaging of glass tubes, every process still needs to be improved and improved to approach the international level. The problems of thin wall, light weight, specification and dimensional tolerance, quality inspection and packaging of molded bottles are far from being considered and solved in China. The pharmaceutical packaging container products of American Witton company not only have automatic detection (every product is inspected, unqualified products are eliminated, and the packaged products are 100% qualified), but also have very perfect and advanced laboratories and detection laboratories. However, our domestic pharmaceutical glass factory and plastic bottle manufacturing enterprises have basically no automatic testing of products. Most of the testing instruments and equipment outside the test room and quality inspection room are neither advanced nor perfect, and many tests and testing items cannot be done or not done. The product quality is out of control or partially out of control, and this problem has not been paid enough attention by enterprises

natural rubber plugs need to be eliminated.

the last company we visited was the west company. The company is the largest pharmaceutical rubber products company in the world. Its headquarters and a factory of the company we visited this time are located in Pennsylvania, USA

through the investigation of West's company in the United States, we learned that natural rubber stoppers with many disadvantages and hazards have long been used in the world, including developing countries, for the bottle stoppers used for antibiotic powder injections, large infusion, freeze-dried preparations and biological preparation packaging, but they are still widely used in China. According to the statistics of rubber stopper production in 1996, the total output of rubber stoppers for infusion and antibiotic bottles in China is 9.552 billion, of which the output of butyl rubber stoppers is only 1.4 billion, accounting for 14.7% of the total. The actual use is much less than the output. This is a serious problem that should be paid attention to by health and pharmaceutical administration departments at all levels

compared with west company of the United States, China also has a big gap in the production, technology and quality management of pharmaceutical butyl rubber bottle closures. For example, there are more than 2000 formulas for the products of west company. At present, there are few formulas in China, which can not meet the packaging requirements of many drugs. Heat sources, microorganisms and particles should be checked for each batch of wash free products of West's company, and the degree of silicification should also be tested according to the user's requirements. However, the industrial standards of similar products in China have no provisions in this regard, and the rubber stopper manufacturers and users have not strictly controlled these quality indicators. The cleanliness of the washless product production workshop of West's company is controlled at 100000, 10000 and 100 levels respectively. Their software and hardware are in place, and have passed the ISO9002 certification and FDA inspection. At present, the clean workshops of butyl rubber stopper production plants in China are not really in place, and there are areas that need to be improved in both software and hardware to varying degrees

in conclusion, through the investigation of relevant enterprises in the United States, it is deeply felt that China's pharmaceutical packaging and pharmaceutical packaging material industry has made great progress after more than ten years of hard work, but it is still lagging behind. The leaders of pharmaceutical management departments at all levels, pharmaceutical enterprises, pharmaceutical packaging materials enterprises and related machinery production enterprises and the majority of pharmaceutical packaging workers should have a strong sense of crisis, urgency and sense, and should make real efforts to realize the scientific and technological progress and modernization of the pharmaceutical industry and pharmaceutical packaging industry. There is no way out for pharmaceutical packaging without paying attention to the packaging of drugs, strengthening the supervision and management of packaging quality in pharmaceutical factories according to law, eliminating backward packaging of drugs, and promoting new and excellent packaging products

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