Common problems and development directions of clean room decoration and purification projects in the pharmaceutical field1

In the field of medicine and health, the requirements for the decoration of dust-free workshops are very strict, but at present, the design of some medical purification projects is unreasonable, and there are still many problems. The key technology of the medical purification engineering pharmaceutical cleanroom is mainly to control dust and microorganisms. As pollutants, microorganisms are the top priority of medical clean room control. The pollutants accumulated in the medical plant pharma machinery and pipelines can directly contaminate the drugs without affecting the cleanliness test. Therefore, we say: GMP requires air cleaning technology, and air cleaning technology does not represent GMP. According to the survey, there are generally two situations in the GMP technology transformation of pharmaceutical factory buildings: ① The application of purification engineering technology in the process of pollution control is unfavorable, which eventually led to some pharmaceutical factories investing huge sums of money in transformation, but the quality of drugs did not improve significantly. ② Most of the clean room HVAC systems in pharmaceutical factories have poor energy-saving effect, resulting in unnecessary expenditure and increasing the production cost of drugs. In recent years, my country's pharmaceutical industry has developed vigorously. In 2002, the sales output value was 230 billion yuan, providing a market share of about 4.5 billion yuan for purification engineering technology every year. The GMP certification of pharmaceutical manufacturers has created 3 billion yuan for 'clean technology'. Yuan's business opportunities, obviously, medicine and medical care have become hot spots in the purification engineering market today. GMP is the 'Good Manufacturing Practice for Drugs', which is formulated in accordance with the 'Pharmaceutical Administration Law of the People's Republic of China'. It is the basic criterion for the quality of drug production and reflects the control requirements for the entire process of drug production. The basic control requirements are put forward for the main factors affecting the quality in production, and the 'production environment' is also guaranteed by purification engineering technology. The new version of drug GMP has greatly improved the requirements for sterility and purification in the production process, which not only puts forward standards for the equipment of drug manufacturers, but also puts forward corresponding regulations for the design, manufacture and installation of equipment used in the aseptic process. Therefore, while the new version of drug GMP brings opportunities for the development of the pharmaceutical industry, it will also usher in a new development climax for purification projects. As far as the market is concerned, currently only 10% of domestic pharmaceutical companies have passed the new version of GMP certification, and 70% of them need to be transformed and upgraded. Domestic pharmaceutical machinery and equipment companies have price advantages, and they have won the first place in this market transformation battle. Seize the opportunity in a timely manner to upgrade equipment and technology to meet market demand, which will become a magic weapon for purification engineering companies to win. Some purification engineering enterprises, in order to improve the process technology and equipment skills of solid preparations, carry out design and improvement and testing on the basis of the original equipment, overcome the shortcomings and deficiencies of traditional equipment, and greatly improve the technical performance of equipment and processes. Innovative improvements have reduced production costs, improved production quality, and stimulated new market opportunities. The implementation and promotion of the new version of GMP has put forward requirements for the transformation and upgrading of pharmaceutical purification engineering enterprises. It is necessary to focus on improving quality and efficiency, and promote the industry to enter the middle and high end. On the one hand, efforts are made to transform and upgrade the quality basic work; on the other hand, increase investment in R&D and human capital to promote technological breakthroughs and improve personnel quality. All in all, purification engineering enterprises can achieve long-term development only by grasping the quasi-opportunities.

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