Sanitary rules for pharmaceutical manufacturing facilities.

These Sanitary rules apply to existing, projected, newly built and reconstructed enterprises for the manufacturing of drugs. In the process of manufacturing of drugs working personnel may be exposed to a number of harmful factors, the main one is chemical, and in enterprises using microbiological synthesis, in addition, and biological harmful factor. As a rule, the combined action of different adverse factors. In isolated rooms, technological processes should be carried out: (a) manufacturing of injection solutions; (b) manufacturing by microbiological synthesis; (c) manufacturing of children's dosage forms and other sterile products; (d) operations with the release of significant amounts of dust, vapors and gases (unpacking, grinding, sifting, etc.); and (e) manufacturing with the use or formation of coloring and smelly substances. In case of bacterial contamination, cleaning should be carried out with preliminary disinfection of the surfaces of the premises and equipment. When developing new systems for the synthesis of drugs, preference should be given to the use of the least toxic substances. Temporary storage of waste should be carried out in special rooms equipped with a ventilation system. When designing enterprises for the manufacturing of drugs, shall be submitted data containing the following information: (a) description of the main physicochemical parameters of the soil of the built-up areas (soil background): soil type, pH, organic matter content and the expected specific chemical and biological components of emissions and industrial waste; (b) data on the quantity and quality (by hazard class) of the estimated industrial waste in accordance with the projected production development volume; (c) description of the possible consequences of the impact of industrial wastes and garbage on the soil; and (d) measures for sanitary protection of the soil.