The gradual implementation of the new GMP and the successive promulgation of the national environmental protection policy have caused the medical and pharmaceutical industry to embark on a new round of clean and environmental protection. The new policy has played a positive role in accelerating the upgrading of medical clean equipment and clean engineering. The medical pharmaceutical and clean industry will usher in a new development opportunity.
In fact, a long time ago there was knowledge about cleansing, and it can even be traced back to the era when the ancients first realized the importance of microbial “cleanliness” to medicines, which is often called “hygiene”. It is also the first method of medical science to adopt clean techniques of modern science, such as the practice of Thermovets and Liszt. They recommended disinfection methods used in hospitals and operating rooms to significantly reduce patient infection and mortality. The understanding of what they do in science is ultimately to realize that there is “invisible” pollution and that this pollutant must be controlled.
In today's society, with the rapid development of the medical industry, people pay more and more attention to life and health. In order to be competitive in the life sciences market, in order to provide healthy and safe quality products for consumers, patients and surgeons (doctors, nurses, etc.), the risk of infection caused by microorganisms must be carefully considered. As a result, the cleanliness of medical drugs, health products, medical products such as machines, reusable surgical instruments, implants and artificial hip joints is increasingly entering the public eye.
The facts and figures below also illustrate the hygiene and cleanliness of medical products.
The number of nosocomial infections is increasing: there are about 500,000 cases in Germany each year, of which 10,000 (equal to 2%) are fatal.
There are recalls initiated by the US Food and Drug Administration (FDA): 243 cases were reported in 2001-2011, of which 64 (26%) were caused by cleanliness, which has been on the rise in the past few years.
Although the importance of cleansing for medical products has been known for many years and is written in countless national and international standards (such as the legal framework for EU medical products, by 90/385/EEC, 93/42/EEC and 98/97/ The EC consists of three directives that give four risk levels for medical products from low risk to high risk). However, there are still problems caused by poor hygiene or cleanliness, in which postoperative costs are increased due to rejection of the implant, rejection of reaction or inflammation, and an estimated 7 billion euros per year in Germany. Many medical companies have been troubled, and the health and sanitation problems of medical and pharmaceutical products are urgently needed to be solved.
Under this circumstance, the development and application of clean technology will undoubtedly make a sigh of relief for enterprises with high requirements in production and operating environment, such as medical pharmaceutical manufacturers. The construction of the clean room of the enterprise can not only exclude the pollutants such as fine particles, harmful air and bacteria in the air in the production space of the product, but also ensure that the production environment is clean and dust-free; it can also effectively control the infection and promotion of products caused by microorganisms. product quality. It is also a major trend in development.