Sterile and aseptically prepared dosage forms

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Voronezh: VSU CPI, 2008. — 279s. : Tutorial for students. , training. specialty 060108 Pharmacy . The manufacture of sterile medicines is an independent section of pharmaceutical technology, which is constantly being improved on the basis of the latest achievements of science and practice. Modern requirements for parenteral drugs are most fully implemented in factory conditions that provide a high degree of purity, stability, sterility, exact dosage, etc. according to GMP rules. However, this fact does not in any way reduce the relevance, the need to expand the capabilities of the manufacture of sterile extremal dosage forms .. The need for sterile and aseptically prepared dosage forms is caused by a special method of their use. Injections are injected into the body through a hollow needle with a violation of the integrity of the skin and mucous membranes . The presence of microorganisms in the solution can lead to infection of the body, and, consequently, to serious consequences. Medicinal forms with antibiotics require aseptic cooking conditions, since in the presence of microorganisms, many antibiotic substances lose their activity. The dosage forms under consideration, regardless of whether they are further sterilized or not, should be prepared under aseptic conditions. Sanitary requirements for the preparation of medicines in aseptic conditions are regulated by order of the Ministry of Health of the Russian Federation No. 309 from 21. 10. 1997. "On approval of the instructions on the sanitary regime of pharmacy organizations (pharmacies)" . Medicinal forms manufactured under aseptic conditions include: dosage forms for injection, dosage forms for eye treatment, dosage forms with antibiotics, dosage forms for children. These dosage forms should not contain microorganisms and their spores. Injectable solutions are subject to extremely high requirements. They must be sterile, free of apyrogenic substances, mechanical impurities, stable during sterilization and storage. Attention to aseptic should permeate all stages of the technological process
LF/152415896/R
Data sheet
- Name of the Author
- Дзюба В.Ф.
Зубова С.Н.
Сливкин А.И. - Language
- Russian