A few days ago, the Food and Drug Administration issued the "Guiding Opinions on Further Strengthening the Work of Food and Drug Standards" (hereinafter referred to as "Opinions"). The "Opinions" proposes that by 2020, 3,050 national drug standards should be revised and 500 medical device standards should be revised. The industry analysts analyzed that the establishment of this target means that the process of ensuring drug safety in China will speed up, and the drug standards will be upgraded, more perfect and strict.
Drug safety has always been the focus of attention from all walks of life. It involves not only major people's livelihood and public safety issues, but also the health of the people and the harmony and stability of society. The promulgation of the "Opinions" will promote the standardization, standardization and scientific development of China's pharmaceutical industry, and will also formulate and put forward more stringent standards and requirements for the pharmaceutical equipment industry.
The role of pharmaceutical equipment in the pharmaceutical industry is self-evident. It is a device that is in close contact with pharmaceuticals and a key link in the production of pharmaceuticals. Pharmaceutical products are actually heavily responsible for the multiple concerns that drug safety has been given and the gradual improvement and strictness of industry standards. Therefore, it is necessary for pharmaceutical companies to invest more energy in the production and innovation of pharmaceutical equipment.
The author understands that the "Opinions" in the protection of drug safety, it is proposed to reflect the concept of drug quality from the design, the whole process of control and production support. In this regard, pharmaceutical companies need to do a good job in quality supervision of equipment production, and ensure the reliability of equipment from the source. Taking the design of the aseptic preparation workshop process as an example, the most emphasized aseptic preparations are aseptic and clean. Many pharmaceutical companies are also cautious and careful in selecting the production equipment for aseptic preparations.
In particular, the pharmaceutical equipment required for a sterile preparation should be simple in structure and smooth on the surface of the device. In addition, the pharmaceutical device needs to be easy to clean, resistant to sterilization and corrosion. Experts suggest that pharmaceutical equipment for the production of sterile drugs should be made of high-quality low-carbon stainless steel. The selection of the main production equipment should also give priority to advanced and mature equipment at home and abroad. From this point of view, although the surface does not seem to be complicated in the production of such equipment, in fact, the requirements for equipment quality and technology are high.
In addition, the "Opinions" also mentioned the need to improve the scientific and technological innovation capabilities of medical device standards, and lead the development of high-tech products to accelerate the integration with the level of internationalization. Relevant experts also said that the investment prospects of the domestic pharmaceutical equipment industry are actually very broad, and with the issuance of the "Opinions on Deepening the Reform of the Examination and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices" and the formation of the pharmaceutical medical device innovation system, domestic pharmaceutical equipment The industry will also focus on innovation to achieve the goal of developing innovative, safe, and sophisticated pharmaceutical equipment.
The author was informed that in order to ensure the safety of the people on the tip of the tongue, some pharmaceutical companies use advanced production techniques to start from the details and integrate innovative ideas into the research and development of pharmaceutical equipment. For example, laser marking machines widely used in medical packaging. In recent years, the newly developed carbon dioxide laser marking machine has appeared in the laser marking machine market. The laser marking technology used by the machine has clean and clean features, which can not only guarantee The pharmaceutical packaging production environment is clean and tidy, and there is no need to consider the consumption of materials. In addition, the carbon dioxide laser marking machine also meets the user's desire for high-speed marking equipment, can quickly complete the marking printing, and even complete the complex structure of the marking printing.
However, at present, China's development in the laser marking machine industry has not yet fully integrated with the international level. In order to truly innovate in pharmaceutical equipment technology, further break away from the shortcomings of industry development and fill the gaps in technology, local pharmaceutical companies must go abroad, integrate global resources, and strive for cooperation through cooperation, mergers and acquisitions or other powerful methods. As a high-quality technical resource, it will add color to the enterprise itself and the future of the industry.
In general, pharmaceutical standards are becoming more and more perfect and higher and higher. In order to meet high requirements and high standards and protect the lives of the people, pharmaceutical companies should do their best to do quality production, supervision and innovation. jobs. Only in this way can China's pharmaceutical industry be more secure and more emboldened on the road of development.
(Author: Fan Ying)
Nitrogen Generator,Nitrogen Gas Generator,Nitrogen Compressor,N2 Generator
Hangzhou Zhongju air separation equipment manufacturing Co., Ltd , https://www.hzzjkfzz.com