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Volumn 54, Issue 2, 2000, Pages 117-135

Carrying out biological qualification, the control operation of moist- heat (steam sterilization) processes for producing sterile pharmaceuticals and medical devices

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BACTERIAL COUNT; BACTERIAL SPORE; BIOTECHNOLOGY; DEVICE; DISINFECTION; DRUG MANUFACTURE; DRUG STERILITY; GOOD MANUFACTURING PRACTICE; METHODOLOGY; MICROORGANISM; PHARMACEUTICAL ENGINEERING; PROCESS CONTROL; WATER VAPOR;

EID: 0034030731     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (15)

References (17)
  • 1
    • 0343517770 scopus 로고
    • Thermally processed low-acid foods packaged in hermetically sealed containers. Part 113
    • Federal Register. Thermally processed low-acid foods packaged in hermetically sealed containers. Part 113. Federal Register 44(53), 16215-16238. (1979).
    • (1979) Federal Register , vol.44 , Issue.53 , pp. 16215-16238
  • 2
    • 0242357704 scopus 로고
    • Human drugs, current good manufacturing practice in manufacture, processing, packaging or holding of large volume parenterals (proposed rules)
    • Federal Register. Human drugs, current good manufacturing practice in manufacture, processing, packaging or holding of large volume parenterals (proposed rules). Federal Register 41(106), 22202-22219. (1976).
    • (1976) Federal Register , vol.41 , Issue.106 , pp. 22202-22219
  • 4
    • 0039795012 scopus 로고
    • The endpoint of a preservation process
    • I. J. Pflug, "The endpoint of a preservation process," J. Food Protection 50(4), 347-351. (1987a).
    • (1987) J. Food Protection , vol.50 , Issue.4 , pp. 347-351
    • Pflug, I.J.1
  • 5
    • 0343517768 scopus 로고
    • The use of bacterial spores as sterilization process monitoring devices: A discussion of what they can do and some of their limitations
    • Lincolnshire, IL. Pharmaceutical Manufacturers Association, Washington, D.C.
    • I. J. Pflug and R. G. Holcomb, The Use of Bacterial Spores as Sterilization Process Monitoring Devices: A Discussion of What They Can Do and Some of Their Limitations. Proceedings of the Third PMA Seminar Program on Validation of Sterile Manufacturing Processes, Lincolnshire, IL. Pharmaceutical Manufacturers Association, Washington, D.C. (1980).
    • (1980) Proceedings of the Third PMA Seminar Program on Validation of Sterile Manufacturing Processes
    • Pflug, I.J.1    Holcomb, R.G.2
  • 7
    • 0343488289 scopus 로고
    • The mechanics and interpretation of heat penetration tests in canned foods
    • E. V. Alstrand and O. F. Ecklund, "The mechanics and interpretation of heat penetration tests in canned foods," Food Tech. 6, No. 5 185-189. (1952).
    • (1952) Food Tech. , vol.6 , Issue.5 , pp. 185-189
    • Alstrand, E.V.1    Ecklund, O.F.2
  • 8
    • 0017035820 scopus 로고
    • Occurrence and thermoresistance of spores of psychrophilic and psychrotrophic aerobic sporeformers in soil and foods
    • M. J. M. Michels and F. M. W. Visser, "Occurrence and thermoresistance of spores of psychrophilic and psychrotrophic aerobic sporeformers in soil and foods," J. Applied Bacteriology 41, 1-11. (1976).
    • (1976) J. Applied Bacteriology , vol.41 , pp. 1-11
    • Michels, M.J.M.1    Visser, F.M.W.2
  • 11
    • 0011843541 scopus 로고
    • Sporeformers as food spoilage organisms
    • (eds. G. W. Gould and A. Hurst) Ch. 15., London: Academic Press
    • M. Ingram, "Sporeformers as food spoilage organisms." (eds. G. W. Gould and A. Hurst) In The Bacterial Spore, Ch. 15., London: Academic Press. (1969).
    • (1969) The Bacterial Spore
    • Ingram, M.1
  • 12
    • 0343517766 scopus 로고
    • The destruction of the bacterial spore
    • (ed. Hugo, W. B.) Chapter II. London: Academic Press
    • A. D. Russell, "The destruction of the bacterial spore." In Inhibition and Destruction of the Microbial Cell (ed. Hugo, W. B.) Chapter II. London: Academic Press. (1971).
    • (1971) Inhibition and Destruction of the Microbial Cell
    • Russell, A.D.1
  • 14
    • 0018488572 scopus 로고
    • Biological validation of a sterilization process for a parenteral product-fractional exposure method
    • R. A. Caputo, T. E. Odlaug, R. L. Wilkinson, and C. C. Mascoli, "Biological validation of a sterilization process for a parenteral product-fractional exposure method." Bulletin Parenteral Drug Association 33, 214-221 (1967).
    • (1967) Bulletin Parenteral Drug Association , vol.33 , pp. 214-221
    • Caputo, R.A.1    Odlaug, T.E.2    Wilkinson, R.L.3    Mascoli, C.C.4
  • 15
    • 0040177504 scopus 로고
    • Survivor curves of bacterial spores heated in parenteral solutions
    • Eds. A. N. Barker, J. Wolf, D. J. Eller, D. J. Dring, and G. W. Gould. Academic Press, London
    • I. J. Pflug and G. M. Smith, "Survivor curves of bacterial spores heated in parenteral solutions." Spore Research 1976. Vol. 2. Eds. A. N. Barker, J. Wolf, D. J. Eller, D. J. Dring, and G. W. Gould. Academic Press, London (1977).
    • (1977) Spore Research 1976 , vol.2
    • Pflug, I.J.1    Smith, G.M.2
  • 16
    • 0014066557 scopus 로고
    • Recovery patterns of spores of Putrefactive Anaerobe 3679 in various subculture media after heat treatment
    • J. A. L. Augustin, and I. J. Pflug, "Recovery patterns of spores of Putrefactive Anaerobe 3679 in various subculture media after heat treatment." Applied Microbiology 15, 266-276 (1967).
    • (1967) Applied Microbiology , vol.15 , pp. 266-276
    • Augustin, J.A.L.1    Pflug, I.J.2
  • 17
    • 0019569964 scopus 로고
    • Bacillus coagulans FRR B666, as a potential biological indicator organism
    • A. T. Jones and I. J. Pflug, "Bacillus coagulans FRR B666, as a potential biological indicator organism." Journal of Parenteral Science and Technology, 35, 82-87 (1981).
    • (1981) Journal of Parenteral Science and Technology , vol.35 , pp. 82-87
    • Jones, A.T.1    Pflug, I.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.