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  • Title: [Hygienic precautions and microbiological quality control during the manufacturing of sterile drugs].
    Author: Züge R.
    Journal: Zentralbl Bakteriol Mikrobiol Hyg B; 1982 May; 176(2-3):134-41. PubMed ID: 7124163.
    Abstract:
    By the use of an example such as the production of a sterile solution, the hygienic precautions and control procedures required in the pharmaceutical industry are described. Starting materials should be free of germs and pyrogens. During production experimentally tested cleaning procedures for equipment are to be observed. A critical production step is the filtration. The time limits between starting and sterilizing the solution as well as the leakproofness of the filters have to be tested microbiological. --Special microbiological requirements exist for rooms, surfaces and clothes. Process-sterility control is carried out by periodic filling of ampules with nutrient broth. After running through the "compact unit" of the aseptic filling line the ampules contaminated before with endotoxin, are free of pyrogens. --Sterility depends on the count and kind of germs before sterilization procedure. The probability of survival of microorganismen should be less than 1:1 million.
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