메뉴 건너뛰기




Volumn , Issue , 2004, Pages 15-44

Microbial limits

Author keywords

[No Author keywords available]

Indexed keywords


EID: 84964537138     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter
Times cited : (10)

References (51)
  • 1
    • 2942581693 scopus 로고    scopus 로고
    • Microbial limit test
    • Rockville, Maryland: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Microbial limit test. In U.S. Pharmacopoeia. Rockville, Maryland: United States Pharmacopeial Convention, 2002;1873-1878.
    • (2002) U.S. Pharmacopoeia , pp. 1873-1878
  • 2
    • 85056498431 scopus 로고    scopus 로고
    • 21 Part 211.113: Control of microbiological contamination. Rockville, Maryland
    • Federal Register of the United States of America. Code of Federal Regulations. Subpart F: Production and Process Control, 21 Part 211.113: Control of microbiological contamination. Rockville, Maryland, 1996.
    • (1996) Code of Federal Regulations. Subpart F: Production and Process Control
  • 3
    • 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
  • 4
    • 0042320712 scopus 로고    scopus 로고
    • Developing a viable environmental program for non-sterile pharmaceutical operations
    • Reich RR, Miller MJ, Paterson H. Developing a viable environmental program for non-sterile pharmaceutical operations. Pharm Technol 2003; 27:92-100.
    • (2003) Pharm Technol , vol.27 , pp. 92-100
    • Reich, R.R.1    Miller, M.J.2    Paterson, H.3
  • 5
    • 0002546433 scopus 로고    scopus 로고
    • Microbiological monitoring of environmental conditions for non-sterile pharmaceutical manufacturing
    • Mestrandrea LW. Microbiological monitoring of environmental conditions for non-sterile pharmaceutical manufacturing. Pharm Technol 1997; 21:59-74.
    • (1997) Pharm Technol , vol.21 , pp. 59-74
    • Mestrandrea, L.W.1
  • 6
    • 85056505817 scopus 로고    scopus 로고
    • European Pharmacopoeia. 3rd ed. Strasbourg, France: Council of Europe
    • European Pharmacopoeial Convention. Microbiological examination of nonsterile products. European Pharmacopoeia. 3rd ed. Strasbourg, France: Council of Europe, 2001;70-78.
    • (2001) Microbiological examination of nonsterile products , pp. 70-78
  • 7
    • 85056549182 scopus 로고    scopus 로고
    • 13th ed. Tokyo, Japan: The Society of Japanese Pharmacopoeia
    • The Japanese Pharmacopoeia. Microbial Limit Test. 13th ed. Tokyo, Japan: The Society of Japanese Pharmacopoeia, 1996;49-54.
    • (1996) Microbial Limit Test , pp. 49-54
  • 8
    • 0003228266 scopus 로고    scopus 로고
    • Contamination of non-sterile pharmaceuticals in hospital and community environments
    • Hugo WB, Russell AD, eds, 6th ed. Oxford, England: Blackwell Science, Chapter 19
    • Baird R. Contamination of non-sterile pharmaceuticals in hospital and community environments. In: Hugo WB, Russell AD, eds. Pharmaceutical Microbiology. 6th ed. Oxford, England: Blackwell Science, 1998:374-384. Chapter 19.
    • (1998) Pharmaceutical Microbiology , pp. 374-384
    • Baird, R.1
  • 15
    • 0015782794 scopus 로고
    • Etude de la contaminacion microbienne de diverses preparations pharmaceutiques
    • Desvignes A, Sebastien F, Benard J, Campion G. Etude de la contaminacion microbienne de diverses preparations pharmaceutiques. Ann Pharm Fr 1973; 31:775-785.
    • (1973) Ann Pharm Fr , vol.31 , pp. 775-785
    • Desvignes, A.1    Sebastien, F.2    Benard, J.3    Campion, G.4
  • 16
    • 0015047027 scopus 로고
    • Controllo della contaminazione microbica in preparati farmaceutici orally e topici col metodo delle membrane filtranti
    • Coppi G, Genova R. Controllo della contaminazione microbica in preparati farmaceutici orally e topici col metodo delle membrane filtranti. Farmaco 1970; 26:224-229.
    • (1970) Farmaco , vol.26 , pp. 224-229
    • Coppi, G.1    Genova, R.2
  • 17
    • 85056538670 scopus 로고    scopus 로고
    • Evaluation of preservative effectiveness in pharmaceutical products: The use of a wild strain of Pseudomonas cepacia
    • Zani F, Minutello A, Maggi L, Santi P, Mazza P. Evaluation of preservative effectiveness in pharmaceutical products: The use of a wild strain of Pseudomonas cepacia. J Appl Microbiol 1997; 43:208-212.
    • (1997) J Appl Microbiol , vol.43 , pp. 208-212
    • Zani, F.1    Minutello, A.2    Maggi, L.3    Santi, P.4    Mazza, P.5
  • 18
    • 0023796926 scopus 로고
    • Comparison of rapid NFT and API 20E with conventional methods for identification of gram-negative nonfermentative bacilli from pharmaceutical and cosmetics
    • Palmieri MJ, Carito SL, Meyer J. Comparison of rapid NFT and API 20E with conventional methods for identification of gram-negative nonfermentative bacilli from pharmaceutical and cosmetics. Appl Environ Microbiol 1988; 54:2838-3241.
    • (1988) Appl Environ Microbiol , vol.54 , pp. 2838-3241
    • Palmieri, M.J.1    Carito, S.L.2    Meyer, J.3
  • 19
    • 0028791076 scopus 로고
    • Microbiological quality of pharmaceutical raw materials
    • De La Rosa MC, Medina MR, Vivar C. Microbiological quality of pharmaceutical raw materials. Pharm Acta Helv 1995; 70:227-232.
    • (1995) Pharm Acta Helv , vol.70 , pp. 227-232
    • De La Rosa, M.C.1    Medina, M.R.2    Vivar, C.3
  • 20
    • 0024549560 scopus 로고
    • Microbial contamination of cosmetics and personal care items in Egypt-shaving creams and shampoos
    • Abdelaziz AA, Ashour MSE, Hefnai H, El-Tayeb OM. Microbial contamination of cosmetics and personal care items in Egypt-shaving creams and shampoos. J Clin Pharmacol Ther 1989; 14:29-34.
    • (1989) J Clin Pharmacol Ther , vol.14 , pp. 29-34
    • Abdelaziz, A.A.1    Ashour, M.S.E.2    Hefnai, H.3    El-Tayeb, O.M.4
  • 22
    • 0017074654 scopus 로고
    • Pseudomonas aeruginosa infections associated with use of contaminated medicaments
    • Baird R, Shooter RA. Pseudomonas aeruginosa infections associated with use of contaminated medicaments. Br Med J 1976; 2:349-350.
    • (1976) Br Med J , vol.2 , pp. 349-350
    • Baird, R.1    Shooter, R.A.2
  • 23
    • 0023615782 scopus 로고
    • A comparison of two incubation temperatures for the isolation of gram negative contaminants from raw materials and nonsterile pharmaceuticals
    • Ferguson A, Patel A, Bair RM. A comparison of two incubation temperatures for the isolation of gram negative contaminants from raw materials and nonsterile pharmaceuticals. J Clin Pharmacol Ther 1987; 12:249-254.
    • (1987) J Clin Pharmacol Ther , vol.12 , pp. 249-254
    • Ferguson, A.1    Patel, A.2    Bair, R.M.3
  • 24
    • 0015313775 scopus 로고
    • Etude de la contamination microbienne des sirops pharmaceutiques
    • Lambin MS, Desvignes A, Kiger JL, Azaria M. Etude de la contamination microbienne des sirops pharmaceutiques. Ann Pharm Fr 1972; 30:161-168.
    • (1972) Ann Pharm Fr , vol.30 , pp. 161-168
    • Lambin, M.S.1    Desvignes, A.2    Kiger, J.L.3    Azaria, M.4
  • 25
    • 0028321795 scopus 로고
    • Microbial contamination and preservative efficacy of topical creams
    • Na’was T, Alkofahi A. Microbial contamination and preservative efficacy of topical creams. J Clin Pharmacol Ther 1994; 19:41-46.
    • (1994) J Clin Pharmacol Ther , vol.19 , pp. 41-46
    • Na’was, T.1    Alkofahi, A.2
  • 26
    • 0039521245 scopus 로고    scopus 로고
    • Microbial contamination of antiseptics and disinfectants
    • Oie S, Kamiya A. Microbial contamination of antiseptics and disinfectants. AmJ Infect Control 1996; 24:389-395.
    • (1996) AmJ Infect Control , vol.24 , pp. 389-395
    • Oie, S.1    Kamiya, A.2
  • 27
    • 0015608737 scopus 로고
    • Microbial contamination of topical ointments
    • Wargo EJ. Microbial contamination of topical ointments. Am J Hosp Pharm 1973; 30:332-335.
    • (1973) Am J Hosp Pharm , vol.30 , pp. 332-335
    • Wargo, E.J.1
  • 28
    • 0029258142 scopus 로고
    • The danger of infections of the hospitalized patients with the microorganisms present in preparations and in the hospital environment
    • Zembrzuska-Sadkowska E. The danger of infections of the hospitalized patients with the microorganisms present in preparations and in the hospital environment. Acta Pol Pharm 1995; 52:173-178.
    • (1995) Acta Pol Pharm , vol.52 , pp. 173-178
    • Zembrzuska-Sadkowska, E.1
  • 29
    • 0029064036 scopus 로고
    • The increasing significance of outbreaks of Acinetobacter spp.: The need for control and new agents
    • Bergogne-Berezin E. The increasing significance of outbreaks of Acinetobacter spp.: The need for control and new agents. J Hosp Infect 1995; (suppl):441-452.
    • (1995) J Hosp Infect , pp. 441-452
    • Bergogne-Berezin, E.1
  • 31
    • 0022394024 scopus 로고
    • Factors associated with Pseudomonas pickettii intrinsic contamination of commercial respiratory therapy solutions marketed as sterile
    • Anderson RL, Bland LE, Favero MS, McNeil BJ, Davis DC, Mackel DC, Gravelle CR. Factors associated with Pseudomonas pickettii intrinsic contamination of commercial 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.E.2    Favero, M.S.3    McNeil, B.J.4    Davis, D.C.5    Mackel, D.C.6    Gravelle, C.R.7
  • 32
    • 0017146653 scopus 로고
    • Flavobacterium meningosepticum in the hospital environment
    • Coyle-Gilchrist MM, Crewe P, Roberts G. Flavobacterium meningosepticum in the hospital environment. J Clin Pathol 1976; 29:824-826.
    • (1976) J Clin Pathol , vol.29 , pp. 824-826
    • Coyle-Gilchrist, M.M.1    Crewe, P.2    Roberts, G.3
  • 33
    • 0022350781 scopus 로고
    • Bacteremias due to Citrobacter diversus and Citrobacter freundii Incidence, risk factors, and clinical outcome
    • Drelichman V, Band JD. Bacteremias due to Citrobacter diversus and Citrobacter freundii. Incidence, risk factors, and clinical outcome. Arch Intern Med 1985; 145:1808-1810.
    • (1985) Arch Intern Med , vol.145 , pp. 1808-1810
    • Drelichman, V.1    Band, J.D.2
  • 35
    • 0025981856 scopus 로고
    • Serious infections involving the CDC group Ve bacteria Chryseomonas luteola and Flavimonas oryzihabitans
    • Hawkins RE, Moriarty RA, Lewis DE, Oldfield EC. Serious infections involving the CDC group Ve bacteria Chryseomonas luteola and Flavimonas oryzihabitans. Rev Infect Dis 1991; 13:257-260.
    • (1991) Rev Infect Dis , vol.13 , pp. 257-260
    • Hawkins, R.E.1    Moriarty, R.A.2    Lewis, D.E.3    Oldfield, E.C.4
  • 36
    • 0031957967 scopus 로고    scopus 로고
    • Nosocomial infections caused by Sphingomonas paucimobilis: Clinical features and microbiological characteristics
    • Hsueh PR, Teng LJ, Yang PC, Chen YC, Pan HJ, Ho SW, Luh KT. Nosocomial infections caused by Sphingomonas paucimobilis: Clinical features and microbiological characteristics. Clin Infect Dis 1998; 26:676-681.
    • (1998) Clin Infect Dis , vol.26 , pp. 676-681
    • Hsueh, P.R.1    Teng, L.J.2    Yang, P.C.3    Chen, Y.C.4    Pan, H.J.5    Ho, S.W.6    Luh, K.T.7
  • 38
    • 0031136588 scopus 로고    scopus 로고
    • Risk factors associated with isolation of Stenotrophomonas (Xanthomonas) malthophilia in clinical specimens
    • VanCouwenberghe CJ, Farver TB, Cohen SH. Risk factors associated with isolation of Stenotrophomonas (Xanthomonas) malthophilia in clinical specimens. Infect Control Hosp Epidemiol 1997; 18:316-321.
    • (1997) Infect Control Hosp Epidemiol , vol.18 , pp. 316-321
    • VanCouwenberghe, C.J.1    Farver, T.B.2    Cohen, S.H.3
  • 39
    • 0034982979 scopus 로고    scopus 로고
    • Setting threshold limits for the significance of objectionable microorganisms in oral pharmaceutical products
    • Manu-Tawiah W, Brescia BA, Montgomery ER. Setting threshold limits for the significance of objectionable microorganisms in oral pharmaceutical products. PDA J Pharm Sci Technol 2001; 55:171-175.
    • (2001) PDA J Pharm Sci Technol , vol.55 , pp. 171-175
    • Manu-Tawiah, W.1    Brescia, B.A.2    Montgomery, E.R.3
  • 40
    • 0034927058 scopus 로고    scopus 로고
    • The role of USP in the assessment of microbiological quality of pharmaceuticals
    • Dabbah R, Knapp J, Sutton S. The role of USP in the assessment of microbiological quality of pharmaceuticals. Pharm Technol 2001; 25:54-60.
    • (2001) Pharm Technol , vol.25 , pp. 54-60
    • Dabbah, R.1    Knapp, J.2    Sutton, S.3
  • 41
    • 0006920414 scopus 로고
    • The clinical significance of the presence of microorganisms in pharmaceutical and cosmetic preparations
    • Parker MT. The clinical significance of the presence of microorganisms in pharmaceutical and cosmetic preparations. J Soc Cosmet Chem 1972; 23:415-426.
    • (1972) J Soc Cosmet Chem , vol.23 , pp. 415-426
    • Parker, M.T.1
  • 43
    • 85056553866 scopus 로고    scopus 로고
    • Microbiological attributes of nonsterile pharmaceutical products
    • Rockville, Maryland: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Microbiological attributes of nonsterile pharmaceutical products. In: U.S. Pharmacopoeia. Vol. 25. Rockville, Maryland: United States Pharmacopeial Convention, 2002;2205-2206.
    • (2002) U.S. Pharmacopoeia , vol.25 , pp. 2205-2206
  • 44
    • 84865347476 scopus 로고    scopus 로고
    • Microbiological quality of pharmaceutical preparations
    • 3rd ed. Strasbourg, France:Council of Europe
    • European Pharmacopoeial Convention. Microbiological quality of pharmaceutical preparations. In: European Pharmacopoeia. 3rd ed. Strasbourg, France:Council of Europe, 2001;294-295.
    • (2001) European Pharmacopoeia , pp. 294-295
  • 45
    • 85056559359 scopus 로고    scopus 로고
    • U.S. Pharmacopoeia, United States Pharmacopeial Convention. Rockville, Maryland
    • United States Pharmacopeial Convention. Validation of microbial recovery from pharmacopeial articles. U.S. Pharmacopoeia, United States Pharmacopeial Convention. Rockville, Maryland, 2000; 25:2259-22261.
    • (2000) Validation of microbial recovery from pharmacopeial articles , vol.25 , pp. 2259-22261
  • 46
    • 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. Pharmacop Forum 2002; 28:2034-2041.
    • (2002) Pharmacop Forum , vol.28 , pp. 2034-2041
    • Cundell, A.M.1
  • 47
    • 85056509759 scopus 로고    scopus 로고
    • Pharmacopeial Reviews. Microbial enumeration tests
    • Anonymous. Pharmacopeial Reviews. Microbial enumeration tests. Pharmacop Forum 1999; 25:7761-7773.
    • (1999) Pharmacop Forum , vol.25 , pp. 7761-7773
  • 48
    • 2942733758 scopus 로고    scopus 로고
    • Pharmacopeial Reviews. Microbiological procedures for the absence of objectionable microorganisms
    • Anonymous. Pharmacopeial Reviews. Microbiological procedures for the absence of objectionable microorganisms. Pharmacop Forum 1999; 25:7774-7784.
    • (1999) Pharmacop Forum , vol.25 , pp. 7774-7784
  • 49
    • 2942754404 scopus 로고    scopus 로고
    • Pharmacopeial Reviews. Microbiological attributes of non-sterile pharmacopeial articles
    • Anonymous. Pharmacopeial Reviews. Microbiological attributes of non-sterile pharmacopeial articles. Pharmacop Forum 1999; 25:7785-7791.
    • (1999) Pharmacop Forum , vol.25 , pp. 7785-7791
  • 50
    • 0011284513 scopus 로고    scopus 로고
    • Microbiological evaluation of clean rooms and other controlled environments
    • Rockville, Maryland: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Microbiological evaluation of clean rooms and other controlled environments. In: U.S. Pharmacopoeia. Vol. 25. Rockville, Maryland: United States Pharmacopeial Convention, 2002;2206-2212.
    • (2002) U.S. Pharmacopoeia , vol.25 , pp. 2206-2212
  • 51
    • 85056508840 scopus 로고    scopus 로고
    • Microbial limits tests-nutritional supplements
    • Rockville, Maryland: United States Pharmacopeial Convention
    • United States Pharmacopeial Convention. Microbial limits tests-nutritional supplements. In U.S. Pharmacopoeia. Rockville, Maryland: United States Pharmacopeial Convention, 2003;2659-2663.
    • (2003) U.S. Pharmacopoeia , pp. 2659-2663


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.