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Volumn , Issue , 2004, Pages 77-102

Sterility test and procedures

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EID: 37349024597     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (1)

References (40)
  • 2
    • 85056532881 scopus 로고    scopus 로고
    • 3rd ed. Strasbourg, France: Council of Europe
    • European Pharmacopoeial Convention. Sterility. European Pharmacopoeia. 3rd ed. Strasbourg, France: Council of Europe, 2001;63-67.
    • (2001) Sterility. European Pharmacopoeia , pp. 63-67
  • 3
    • 85056944398 scopus 로고    scopus 로고
    • Aseptic processing; how good science and good manufacturing practices can prevent contamination
    • Parenteral Drug Association. Aseptic processing; how good science and good manufacturing practices can prevent contamination. PDA Lett 2002; 38:10-11.
    • (2002) PDA Lett , vol.38 , pp. 10-11
  • 11
    • 85056529722 scopus 로고    scopus 로고
    • PDA testifies before FDA pharmaceutical advisory committee
    • Parenteral Drug Association. PDA testifies before FDA pharmaceutical advisory committee. PDA Lett 2002; 38(1):12-15.
    • (2002) PDA Lett , vol.38 , Issue.1 , pp. 12-15
  • 12
    • 0022394024 scopus 로고
    • Factors associated with Pseudomonas picketti intrinsic contamination of commercially respiratory therapy solutions marketed as sterile
    • Anderson RL, Bland LA, Favero MS, McNeil MM, Davis BJ, Mackel DC, Gravelle CR. Factors associated with Pseudomonas picketti intrinsic contamination of commercially respiratory therapy solutions marketed as sterile. Appl Environ Microbiol 1985; 50:1343-1348.
    • (1985) Appl Environ Microbiol , vol.50 , pp. 1343-1348
    • Anderson, R.L.1    Bland, L.A.2    Favero, M.S.3    McNeil, M.M.4    Davis, B.J.5    Mackel, D.C.6    Gravelle, C.R.7
  • 15
    • 0036749573 scopus 로고    scopus 로고
    • Aseptic processing, elephants, blind men, and sterility
    • Akers JE, Agalloco JP. Aseptic processing, elephants, blind men, and sterility. PDA J Sci Technol 2002; 56:231-234.
    • (2002) PDA J Sci Technol , vol.56 , pp. 231-234
    • Akers, J.E.1    Agalloco, J.P.2
  • 17
    • 0003388420 scopus 로고    scopus 로고
    • Bacteria
    • Hugo WB, Russell AB, eds, 6th ed. Oxford, England: Blackwell Science
    • Hugo WB. Bacteria. In: Hugo WB, Russell AB, eds. Pharmaceutical Microbiology. 6th ed. Oxford, England: Blackwell Science, 1998;3-34.
    • (1998) Pharmaceutical Microbiology , pp. 3-34
    • Hugo, W.B.1
  • 18
    • 85056536072 scopus 로고    scopus 로고
    • Vol. 26. Rockville, MD: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Bacterial endotoxin test. US Pharmacopoeia. Vol. 26. Rockville, MD: United States Pharmacopeial Convention, 2003;2023-2026.
    • (2003) Bacterial endotoxin test. US Pharmacopoeia , pp. 2023-2026
  • 19
    • 84887201003 scopus 로고    scopus 로고
    • Sterilizing filtration of liquids
    • Prince R, ed, 1st ed. Baltimore, MD, USA/Surrey, UK:PDA/Davis-Horwood International Publishing Limited
    • Levy RV. Sterilizing filtration of liquids. In: Prince R, ed. Microbiology in Pharmaceutical Manufacturing. 1st ed. Baltimore, MD, USA/Surrey, UK:PDA/Davis-Horwood International Publishing Limited, 2001;399-412.
    • (2001) Microbiology in Pharmaceutical Manufacturing , pp. 399-412
    • Levy, R.V.1
  • 20
    • 0035657542 scopus 로고    scopus 로고
    • Method for qualifying microbial removal performance of 0.1 micron rated filters: Part I. Characterization of water isolates for potential use as standard challenge organisms to qualify 0.1 micron rated filters
    • Sundaram S, Eisenhuth J, Howard G, Brandwein H. Method for qualifying microbial removal performance of 0.1 micron rated filters: Part I. Characterization of water isolates for potential use as standard challenge organisms to qualify 0.1 micron rated filters. PDA J Pharm Sci Technol 2001; 55:346-372.
    • (2001) PDA J Pharm Sci Technol , vol.55 , pp. 346-372
    • Sundaram, S.1    Eisenhuth, J.2    Howard, G.3    Brandwein, H.4
  • 21
    • 0035065854 scopus 로고    scopus 로고
    • Retention of water-borne bacteria by membrane filters: Part II. Scanning electron microscopy (SEM) and fatty acid methyl ester (FAME) characterization of bacterial species recovered downstream of 0.2/0.22 micron rated filters
    • Sundaram S, Mallick S, Eisenhuth J, Howard G, Brandwein H. Retention of water-borne bacteria by membrane filters: Part II. Scanning electron microscopy (SEM) and fatty acid methyl ester (FAME) characterization of bacterial species recovered downstream of 0.2/0.22 micron rated filters. PDA J Pharm Sci Technol 2001; 55:87-113.
    • (2001) PDA J Pharm Sci Technol , vol.55 , pp. 87-113
    • Sundaram, S.1    Mallick, S.2    Eisenhuth, J.3    Howard, G.4    Brandwein, H.5
  • 22
    • 0035652381 scopus 로고    scopus 로고
    • Method for qualifying microbial removal performance of 0.1 micron rated filters: Part III. Bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava
    • Sundaram S, Eisenhuth J, Lewis M, Howard G, Brandwein H. Method for qualifying microbial removal performance of 0.1 micron rated filters: Part III. Bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava. PDA J Pharm Sci Technol 2001; 55:393-416.
    • (2001) PDA J Pharm Sci Technol , vol.55 , pp. 393-416
    • Sundaram, S.1    Eisenhuth, J.2    Lewis, M.3    Howard, G.4    Brandwein, H.5
  • 23
    • 0036324661 scopus 로고    scopus 로고
    • Sterile-filtration-a review of the past and present technologies
    • Jornitz MW, Soelkner PG, Meltzer TH. Sterile-filtration-a review of the past and present technologies. PDA J Sci Technol 2002; 56:192-195.
    • (2002) PDA J Sci Technol , vol.56 , pp. 192-195
    • Jornitz, M.W.1    Soelkner, P.G.2    Meltzer, T.H.3
  • 24
    • 0034030731 scopus 로고    scopus 로고
    • Carrying out the biological qualification: The control operation of moist-heat (steam sterilization) processes for producing sterile pharmaceuticals and medical devices
    • Pflug IJ, Evans KD. Carrying out the biological qualification: the control operation of moist-heat (steam sterilization) processes for producing sterile pharmaceuticals and medical devices. PDA J Sci Technol 2000; 54:117-135.
    • (2000) PDA J Sci Technol , vol.54 , pp. 117-135
    • Pflug, I.J.1    Evans, K.D.2
  • 25
    • 0023006992 scopus 로고
    • Biological indicators in the pharmaceutical and the medical device industry
    • Pflug IJ, Odlaug TE. Biological indicators in the pharmaceutical and the medical device industry. J Parenter Sci Technol 1986; 40:249-255.
    • (1986) J Parenter Sci Technol , vol.40 , pp. 249-255
    • Pflug, I.J.1    Odlaug, T.E.2
  • 26
    • 0036748943 scopus 로고    scopus 로고
    • Study of sterilizing effectivity of different Ethylene Oxide gaseous mixtures using CFCs and HFCs (Oxyfume 12R and 2002R)
    • Cristina de Oliveira D, de Jesus Andreoli Pinto T. Study of sterilizing effectivity of different Ethylene Oxide gaseous mixtures using CFCs and HFCs (Oxyfume 12R and 2002R). PDA J Sci Technol 2002; 56:242-247.
    • (2002) PDA J Sci Technol , vol.56 , pp. 242-247
    • Cristina de Oliveira, D.1    de Jesus Andreoli Pinto, T.2
  • 27
    • 85027096844 scopus 로고    scopus 로고
    • US Pharmacopoeia. Vol. 25. Rockville, MD: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Microbiological evaluation of clean rooms and other controlled environments. US Pharmacopoeia. Vol. 25. Rockville, MD: United States Pharmacopeial Convention, 2002;2206-2212.
    • (2002) Microbiological evaluation of clean rooms and other controlled environments , pp. 2206-2212
  • 28
    • 0003162150 scopus 로고    scopus 로고
    • Ecology of microorganisms as its affects the pharmaceutical industry
    • Hugo WB, Russell AB, eds, 6th ed. Oxford, England: Blackwell Science
    • Underwood E. Ecology of microorganisms as its affects the pharmaceutical industry. In: Hugo WB, Russell AB, eds. Pharmaceutical Microbiology. 6th ed. Oxford, England: Blackwell Science, 1998;339-354.
    • (1998) Pharmaceutical Microbiology , pp. 339-354
    • Underwood, E.1
  • 29
    • 0031753914 scopus 로고    scopus 로고
    • Origin of bacteria in the clean room and their growth requirements
    • Hyde W. Origin of bacteria in the clean room and their growth requirements. PDA J Sci Technol 1998; 52:154-164.
    • (1998) PDA J Sci Technol , vol.52 , pp. 154-164
    • Hyde, W.1
  • 30
    • 85056554840 scopus 로고    scopus 로고
    • 14th ed. Tokyo, Japan: The Society of Japanese Pharmacopoeia
    • The Japanese Pharmacopoeia. Media Fill Test. 14th ed. Tokyo, Japan: The Society of Japanese Pharmacopoeia, 2001;212-215.
    • (2001) Media Fill Test , pp. 212-215
  • 32
    • 0036748952 scopus 로고    scopus 로고
    • Consideration of media fill test for evaluation and control of aseptic processes: A statistical approach to quality criteria
    • Kawamura K, Abe H. Consideration of media fill test for evaluation and control of aseptic processes: a statistical approach to quality criteria. PDA J Sci Technol 2002; 56:235-241.
    • (2002) PDA J Sci Technol , vol.56 , pp. 235-241
    • Kawamura, K.1    Abe, H.2
  • 33
    • 85056505993 scopus 로고    scopus 로고
    • US Pharmacopoeia. Vol. 25. Rockville, MD: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Sterility tests. US Pharmacopoeia. Vol. 25. Rockville, MD: United States Pharmacopeial Convention, 2002;1878-1883.
    • (2002) Sterility tests , pp. 1878-1883
  • 34
    • 85056501982 scopus 로고    scopus 로고
    • 13th ed. Tokyo, Japan: The Society of Japanese Pharmacopoeia
    • The Japanese Pharmacopoeia. Sterility test. 13th ed. Tokyo, Japan: The Society of Japanese Pharmacopoeia, 1996;69-71.
    • (1996) Sterility test , pp. 69-71
  • 35
    • 0026776566 scopus 로고
    • Importance of incubation time in the test for sterility
    • Besajew C. Importance of incubation time in the test for sterility. Pharm Ind 1992; 54:539-542.
    • (1992) Pharm Ind , vol.54 , pp. 539-542
    • Besajew, C.1
  • 36
    • 2942515198 scopus 로고    scopus 로고
    • Review of the media selection and incubation conditions for the compendial sterility and microbial limit tests
    • Cundell AM. Review of the media selection and incubation conditions for the compendial sterility and microbial limit tests. Pharm Forum 2002; 28:2034-2041.
    • (2002) Pharm Forum , vol.28 , pp. 2034-2041
    • Cundell, A.M.1
  • 37
    • 0020545422 scopus 로고
    • A comparison of a disposable membrane filtration system with a direct inoculation system for sterility testing of veterinary biologics
    • Christianson GG, Koski TA. A comparison of a disposable membrane filtration system with a direct inoculation system for sterility testing of veterinary biologics. J Biol Stand 1983; 11:83-89.
    • (1983) J Biol Stand , vol.11 , pp. 83-89
    • Christianson, G.G.1    Koski, T.A.2
  • 38
    • 0026549728 scopus 로고
    • Development of a universal diluting fluid for membrane filtration sterility testing
    • Proud DW, Sutton SV. Development of a universal diluting fluid for membrane filtration sterility testing. Appl Environ Microbiol 1992; 58:1035-1038.
    • (1992) Appl Environ Microbiol , vol.58 , pp. 1035-1038
    • Proud, D.W.1    Sutton, S.V.2
  • 39
    • 0024241246 scopus 로고
    • Improving integrity of pharmaceutical sterility testing: A new robotic approach
    • d’Arbelloff N. Improving integrity of pharmaceutical sterility testing: a new robotic approach. Drug Dev Ind Pharm 1988; 14:2733-2740.
    • (1988) Drug Dev Ind Pharm , vol.14 , pp. 2733-2740
    • d’Arbelloff, N.1
  • 40
    • 85056502838 scopus 로고    scopus 로고
    • US Pharmacopoeia. Vol. 25. Rockville, MD: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Sterility testing-validation of isolator systems. US Pharmacopoeia. Vol. 25. Rockville, MD: United States Pharmacopeial Convention, 2002;2247-2249.
    • (2002) Sterility testing-validation of isolator systems , pp. 2247-2249


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.