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With the increasing demand for product quality in peopl […]
With the increasing demand for product quality in people's lives, pharmaceutical companies and other related industries are making active efforts to meet the international standardization quality requirements of GMP. One of the focuses of GMP at home and abroad is the sterile and dust-free production environment, that is, the clean production workshop. So, what are the characteristics of GMP workshop purification engineering construction?
I. High construction investment costs
The construction cost of the high-grade GMP workshop purification project is very high. Generally speaking, the 100-level vertical unidirectional flow clean workshop has its interior decoration and air-conditioning purification system; if it is added with pure water preparation equipment and system piping, pure gas occurs and System pipelines, wastewater treatment equipment and pipelines, fire protection systems, power distribution and automation systems, vacuum cleaning systems, etc., the construction investment cost per unit area is as high as several yuan / m2.
Second, the operation and management costs are large
Because the high-grade GMP workshop purification project has a large amount of air purification, a large amount of fresh air, and strict temperature and humidity requirements, the air heat and humidity treatment and air distribution have large energy consumption, consume more electricity, and operate at a higher cost.
Third, flexible adaptability
Because science and technology are developing rapidly, high-tech products are constantly appearing, especially the development of the electronics industry is changing with each passing day. For example, the development of integrated circuits will be a new generation in 2~3 years, which requires high-level GMP for its services. The purification plant must be able to adapt to its development speed and have excellent flexibility and adaptability. Because the construction of a clean factory is a hundred years old, it will not be rebuilt in one or two years. Therefore, in the design and construction of the GMP workshop purification project, it is necessary to consider the development and change of the process, and it is necessary to consider the flexibility and adaptability of the clean plant.
Fourth, good security and reliability
From the two characteristics of (1) and (2) above, it can be concluded at what cost to construct and use such a purification workshop. However, in order to produce high-reliability, high-quality high-tech products, it is necessary to have such a production environment. Because, the purpose of the GMP workshop purification project is to use, in order to obtain qualified products with high yield. In order to achieve this goal, the design and construction of clean workshops must be safe and reliable in the first place. Ensure that the cleanliness, temperature and humidity, wind speed, pressure and other parameters of the clean workshop must meet the requirements of the production process to ensure safety, reliability and no accidents. This must not be sloppy, not to be discounted, to be foolproof, only in this way can be effective, in order to achieve the purpose of the GMP workshop purification project.
At present, the GMP workshop purification project of the pharmaceutical factory has been promoted and popularized in China. The pharmaceutical companies are also cautious in the design and construction of the purification workshop. However, China's current standards have not made specific recommendations on the selection of equipment and materials in the design of purification schemes. Construction units are often conservative and backward in material selection and selection due to cost and technology, and many new or modified units lack professional experience in this area. Therefore, after the completion of the GMP workshop purification project, the life is short, energy is wasted, and it is not convenient. Operation and maintenance are not reasonable or can not reflect the requirements of GMP.