The first-line reform of pharmaceutical packaging machinery and materials in the United States
based on the understanding and understanding of the production technology, equipment, testing and management level of some packaging machinery, pharmaceutical packaging materials and containers in the United States, and at the same time, the gap between similar products and enterprises in China is compared. The following is a specific analysis of pharmaceutical packaging automation, filling equipment, glass products, natural rubber plugs and other aspects
the level of packaging automation needs to be improved
h0ppmann is a member of the American Packaging Machinery Manufacturing Association. The equipment designed and manufactured by the company can gradually raise containers, covers and articles of various shapes and structures to a solid rotating disc with ingenious tracks in the 1960s. The arrangement state and direction are consistent, and then they are transported to the next packaging program. The equipment design is very ingenious 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 the packaging work, especially the arrangement and assembly of more complex packaging items, is basically manual. Many operators not only can not guarantee the unity and stability of the packaging, but also will cause pollution to the packaged products. Improving the level of automation and quality of packaging is a very important link for modern pharmaceutical enterprises to implement GMP
there is a big gap in filling equipment
people are most interested in the eye drops filling and packaging line of coszoli machinery company. The eye drop container is composed of high-quality plastic bottle, middle bolt (dropping nozzle) and bottle cap. The filling line can automatically complete the processes of filling liquid medicine, adding suppository, capping, capping, etc
most of the eye drops plastic bottles in China are of poor quality, with rough container processing and serious burrs and flash on the seam line, bottle mouth and bottle cap; 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 during use, so the dropping amount cannot be controlled. In short, it is impossible to ensure the safety and convenience of medication for patients. The eyedrop filling equipment matched with the container is also very simple and primitive. There is a big gap in the automation level from the material, processing and loading control of the equipment, which needs to be improved
the quality of glass products has not been paid enough attention.
law son m ardonweaton is a well-known manufacturer of pharmaceutical glass, plastic containers and equipment in the domestic industry. The company gives people the impression that it maintains 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, China still has a big gap in the production, technology, equipment, product quality and packaging of pharmaceutical glass products. Every process from glass formula, batching method, equipment, precision control, glass melting, furnace refractory, melting process parameter control to tube drawing equipment, process condition control, glass tube quality inspection, glass tube post-treatment (blowing, fine cutting, round mouth, etc.), glass tube packaging, etc. needs to be improved to approach the international level. In terms of thin wall, lightweight, specification and dimension tolerance, quality inspection and packaging of molded bottles, we are far from considering and solving them in China
the pharmaceutical packaging container products of American Witton company not only have automatic testing (each product is tested, unqualified products are eliminated, and percent of the packaged products are Lily lattice), but also have very perfect and advanced laboratories and testing rooms. However, in our domestic pharmaceutical glass factories and plastic bottle manufacturers, the products are basically not automatically tested. Except for the test room, most of the testing instruments and equipment in the quality inspection room are neither advanced nor perfect, and many tests and testing items cannot be done. The product quality is out of control or partially out of control, which has not been paid enough attention by enterprises
natural rubber plugs need to be eliminated.
the west company is the world's largest pharmaceutical rubber products company, with its headquarters in Pennsylvania, the United States. It is understood that the bottle stopper used for antibiotic powder injection, large infusion, freeze-dried preparation and biological preparation packaging has been widely used in the world, including developing countries. However, China is still using a large number of natural rubber stoppers with many shortcomings and hazards. According to the statistics of rubber stopper output in 1996, the total output of rubber stopper for large infusion and antibiotic bottles in China was 9.552 billion, of which the output of butyl rubber bottle stopper was 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, which should be paid attention to by health and pharmaceutical administration departments at all levels
compared with the United States company, there is a big gap in the production, technology and quality management of pharmaceutical butyl rubber bottle stopper in China to achieve the coordinated improvement of multiple links such as synchronous design of materials and end products, system verification, batch utilization and supply. For example, there are more than 2000 formulas for the products of Siemens AG. At present, there are few formulas in China, which can not meet the packaging requirements of many drugs. The heat source, microorganism and particle shall be checked for each batch of wash free products of Siemens AG, and the degree of silicification shall also be tested according to the user's requirements. However, the industry standards for similar products in China do not have such provisions, and the rubber stopper manufacturers and users do not strictly control these quality indicators. The cleanliness of the washless product production workshop of West's company is controlled at 100000, 10000 and 100 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 have not really reached the standard, and there are areas that need to be improved in both software and hardware
to sum up, the three goals of product and market, energy and resources, and sustainable development have been affirmed. Through understanding relevant enterprises in the United States, it is deeply felt that China's pharmaceutical packaging and pharmaceutical packaging materials industry has made great progress after more than ten years of hard work, but still lags behind. Leaders of pharmaceutical management departments at all levels, pharmaceutical enterprises, pharmaceutical packaging materials enterprises and related machinery manufacturing enterprises, as well as the majority of pharmaceutical packaging workers, should have a strong sense of crisis, urgency and sense for the ring block friction and wear testing machine that evaluates the lubrication performance of various lubricants, and should make more practical efforts to realize the scientific and technological progress and modernization of the pharmaceutical industry and pharmaceutical packaging industry. There is no way out for the pharmaceutical packaging industry without paying attention to drug packaging, strengthening the supervision and management of drug packaging quality according to law, eliminating backward drug packaging, and promoting new and excellent packaging products