(6) Some methods can only achieve starting point control or end point control but cannot achieve whole process control, which is the core requirement of GMP.

Only the air cleaning technology of barrier filtration can efficiently, easily and completely process sterilize and remove particulates in the indoor ambient air. However, except for low-resistance products, their resistance is greater.

This is a necessary condition for pharmaceutical production workshops. Among the various dust and bacteria pollution that may be brought about by the pharmaceutical process, the order of magnitude of 105 grains / L (≥ 0.5 μm particles) from outdoor air can be more than 105 particles, while from people, buildings, etc. (except process dust) accounts for 3×103 capsules / L, accounting for only 3% of the former, and at most less than 10%. Therefore, the pollution of the air in various dust and bacteria pollution is the main contradiction.

The principle of air cleaning technology is to achieve a certain degree of cleanliness through air filtration, and at the same time maintain the effective operation of the environmental control system with corresponding management, so as to ensure that drug production is in line with the environmental conditions of drug quality requirements. The application of clean air technology is inseparable from the pharmaceutical production process. The appearance of contamination is not at all accidental, but is related to line interference and aseptic manual procedures. 

The guiding ideology of GMP is: the formation of any drug and drug package material quantity is research (design) and production, not inspection, GMP emphasizes prevention-oriented, in the production process to establish a quality assurance system covering the whole process, the implementation of comprehensive control, so as to ensure that product quality meets the requirements of the standard. The relationship between HEPA filter performance and particle size is shown in Fig. 6-4-9

Studies have shown that air is a carrier and transmitter of pollutants and contains large amounts of dust particles. In the case of antibiotic products, for example, 20% of the pollution in production is brought in by the air system. If the insoluble particles in large infusion products exceed the limit, it will cause harm to patients, and symptoms such as chills, cerebral thrombosis, and myocardial infarction will occur. For the preparation itself is microorganisms, microbial metabolites as raw materials, or its effective role in participating in pharmaceutical processes, such as antibiotic preparations, amino acids, enzyme preparations, etc., it is also necessary to pay attention to microbial contamination. Because microbial contaminated drugs can cause infection and even serious consequences in users, injecting injections of contaminated microorganisms can cause local infection or sepsis. In addition, proprietary Chinese medicine is also a category of products that cannot be ignored. The pollution of proprietary Chinese medicines is mainly caused by the high amount of germs in raw materials, unreasonable production processes, and improper treatment of water sources. If liquid preparations such as mixtures and syrups exceed the standard, they are mostly caused by improper sterilization and lax packaging.

By using clean air technology, the risk of any contamination of pharmaceutical products during the production process can be minimized, and bioparticles and non-bioparticles can be effectively controlled. Only when drug safety is guaranteed, can the safety of patients be guaranteed.