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Volumn 52, Issue 4, 1998, Pages 159-164

Industrial manufacture of parenteral products in The Netherlands. A survey of eight years of media fills and sterility testing

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DETERMINATION; DRUG INDUSTRY; DRUG STERILITY; GOOD LABORATORY PRACTICE; NETHERLANDS; REVIEW; TOTAL QUALITY MANAGEMENT;

EID: 0031784086     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (16)

References (20)
  • 1
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    • Marcel Dekker, Inc. New York/Basel
    • M. J. Akers, Parenteral Qualin Control, Marcel Dekker, Inc. New York/Basel, 1985, pp. 3-5.
    • (1985) Parenteral Qualin Control , pp. 3-5
    • Akers, M.J.1
  • 2
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    • The United States Pharmacopeial Convention Rockville MD
    • United States Pharmacopeia. XVIII. The United States Pharmacopeial Convention Rockville MD, 1970, p. 855.
    • (1970) United States Pharmacopeia , vol.18 , pp. 855
  • 3
    • 3543083060 scopus 로고
    • A new sterility test for antibiotics: An application of the membrane filter technique
    • S. Holdowsky, "A new sterility test for antibiotics: An application of the membrane filter technique," Antibiotics & Chemotherapy, 7(2), 49-54 (1957).
    • (1957) Antibiotics & Chemotherapy , vol.7 , Issue.2 , pp. 49-54
    • Holdowsky, S.1
  • 4
    • 3543141508 scopus 로고
    • The United States Pharmacopeial Convention Rockville MD
    • United States Pharmacopeia, XVIII, The United States Pharmacopeial Convention Rockville MD, 1970, p. 853.
    • (1970) United States Pharmacopeia , vol.18 , pp. 853
  • 5
    • 0019564794 scopus 로고
    • Comparison of two methods for detecting microbial contamination in intraveneous fluids
    • L. M. Posey, R. E. Nutt, and P. D. Thomson "Comparison of two methods for detecting microbial contamination in intraveneous fluids," American J. Hospital Pharm., 38(5), 659-662 (1981).
    • (1981) American J. Hospital Pharm. , vol.38 , Issue.5 , pp. 659-662
    • Posey, L.M.1    Nutt, R.E.2    Thomson, P.D.3
  • 6
    • 0020545422 scopus 로고
    • A comparison of a disposable membrane filtration system with a direct inoculation system for the sterility testing of veterinary biologics
    • G. G. Christianson and T. A. Koski, "A comparison of a disposable membrane filtration system with a direct inoculation system for the sterility testing of veterinary biologics," J. Biological Slandarization, 11(2), 83-89 (1983).
    • (1983) J. Biological Slandarization , vol.11 , Issue.2 , pp. 83-89
    • Christianson, G.G.1    Koski, T.A.2
  • 7
    • 0019442928 scopus 로고
    • An effective alternative for testing antibiotics sterility
    • M. Picket and W. Litski, "An effective alternative for testing antibiotics sterility," Pharm. Technol., 5(5), 63-68 (1981).
    • (1981) Pharm. Technol. , vol.5 , Issue.5 , pp. 63-68
    • Picket, M.1    Litski, W.2
  • 8
    • 3543134523 scopus 로고
    • Evaluation of a closed system for sterility testing of parenterals
    • B. L. Green and W. Litski, "Evaluation of a closed system for sterility testing of parenterals," Pharm. Technol., 3(11), 72-77 (1979).
    • (1979) Pharm. Technol. , vol.3 , Issue.11 , pp. 72-77
    • Green, B.L.1    Litski, W.2
  • 9
    • 3543060866 scopus 로고
    • Praktische Erfahrungen mit einem Einweg-Sterilitäts-Testsystem
    • K. H. Meyer, "Praktische Erfahrungen mit einem Einweg-Sterilitäts-Testsystem," Pharmazeutische Industrie, 44(4), 404-410 (1982).
    • (1982) Pharmazeutische Industrie , vol.44 , Issue.4 , pp. 404-410
    • Meyer, K.H.1
  • 10
    • 3543084223 scopus 로고
    • The United States Pharmacopeial Convention, Rockville MD
    • United States Pharmacopeia, XXIII, The United States Pharmacopeial Convention, Rockville MD, 1995, p. 1980.
    • (1995) United States Pharmacopeia , vol.23 , pp. 1980
  • 15
    • 0026776566 scopus 로고
    • Die Bedeutung der Bebrütungszeit bei der Prüfung auf Sterilität
    • Chr. Besajew, "Die Bedeutung der Bebrütungszeit bei der Prüfung auf Sterilität," Pharmazeutische Industrie, 54(6), 539-542 (1992).
    • (1992) Pharmazeutische Industrie , vol.54 , Issue.6 , pp. 539-542
    • Besajew, Chr.1
  • 16
    • 3543126279 scopus 로고
    • Harmonisation of sterility tests
    • Anonymous, "Harmonisation of sterility tests," Pharmeuropa 7(2), 256-264 (1995).
    • (1995) Pharmeuropa , vol.7 , Issue.2 , pp. 256-264
  • 18
    • 0029929170 scopus 로고    scopus 로고
    • The Glaxo Wellcome barrier isolation filling line
    • N. Noble, D. Rouse, and G. Wyrick, "The Glaxo Wellcome barrier isolation filling line," Pharm. Engineering, 16(4), 8-16 (1996).
    • (1996) Pharm. Engineering , vol.16 , Issue.4 , pp. 8-16
    • Noble, N.1    Rouse, D.2    Wyrick, G.3
  • 19
    • 0030141144 scopus 로고    scopus 로고
    • The ISO draft international standard-aseptic processing of health care products
    • M. S. Korczynski, "The ISO draft international standard-aseptic processing of health care products," PDA J. Pharm. Sci. Technol., 50(3), 189-195 (1996).
    • (1996) PDA J. Pharm. Sci. Technol. , vol.50 , Issue.3 , pp. 189-195
    • Korczynski, M.S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.