【Abstract】According to the spirit of GMP, the quality of drugs is not detected by the final drug inspection, but actually produced. Therefore, GMP focuses on the whole process of production, from controlling results to controlling factors.
As a major aspect, air cleanliness is a major factor of GMP.
In this big factor of air cleanliness, there are also many specific links and factors. Air cleanliness is achieved by controlling all the factors related to it and the changing process of factors.
Air cleaning technology is a technology to create a clean air environment. The application of air cleaning technology first appeared in the "control assembly area" of aerospace instruments, and gradually expanded to precision processing products, painting, large-scale integrated circuits and other electronic and nuclear industries.
In the middle and late 20th century, air cleaning technology began to enter the biological and pharmaceutical industries. Different from ordinary products, medicines are special products related to human health, and have extremely strict requirements in the production process. Raw materials, production process, equipment, software and personnel operations all have clear specifications. In order to prevent the pollution of drugs and packaging materials in production, and to make the environmental control and standardized production of drug production meet the requirements of drug quality, air cleaning technology is essential.
The development of GMP to today is no longer a question of whether GMP needs air cleaning technology, but how to make better use of air cleaning technology.
Clean air technology for biopharmaceutical production
Air cleaning technology is mainly to provide guarantees for the efficient and full-process air disinfection, sterilization, and particle removal required by GMP.
The targets of disinfection, sterilization and removal of particles in production workshops or related places are: human body, objects, surfaces and air.
There are various methods for disinfection, sterilization and particle removal above: human body: hand disinfection, bathing, wearing sterile clothing, and air showering.
Objects and surfaces: cleaning, chemical disinfection, fumigation, moist heat sterilization, dry heat sterilization, radiation sterilization, ethylene oxide sterilization, filter sterilization, etc.
Ordinary disinfection and sterilization methods, although the bacteria are killed, the gas and allergens emitted by the bacteria remain on the site, and there are still some adverse effects;
The barrier filtration method is to keep all the particles and bacteria that can be filtered out of the air outlet. After a short self-purification time, all the air on site will be purified to a certain degree, and the requirement of "sterility" will be truly realized.
In the pharmaceutical production workshop, among the various dust and bacterial pollution that may be brought about by the pharmaceutical process, the amount from outdoor air can reach more than 105 particles/L (particles ≥ 0.5µm), while those from people, buildings, etc. (except process dust) ) accounted for 3×103 grains/L, only 3% of the former, and the most was less than 10%. Therefore, air pollution among various dust and bacterial pollution is the main contradiction.