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Volumn 62, Issue 6, 2008, Pages 429-444

Why and how to implement a rapid sterility test

Author keywords

Chemunex; Comparability protocol; Drug master file; Method validation; Most probable number; Rapid detection instrument; Rapid sterility test; Scan RDI; Viability method

Indexed keywords

AGENTS ACTING ON THE EYE;

EID: 59349115372     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (8)

References (14)
  • 1
    • 11144313371 scopus 로고
    • Tests for the sterility of pharmaceutical preparations
    • Bryce, D. M. Tests for the sterility of pharmaceutical preparations. J. Pharm. Pharmacol. 1956, 8, 561.
    • (1956) J. Pharm. Pharmacol , vol.8 , pp. 561
    • Bryce, D.M.1
  • 3
    • 0014610494 scopus 로고
    • The sterility testing of pharmaceuticals
    • Bowman, F. W. The sterility testing of pharmaceuticals. J. Pharm. Sci. 1969, 58 (11), 1301-1308.
    • (1969) J. Pharm. Sci , vol.58 , Issue.11 , pp. 1301-1308
    • Bowman, F.W.1
  • 5
    • 30544437244 scopus 로고    scopus 로고
    • Roadmap to approval: Use of an automated sterility test method as a lot release test for Carticel, autologous cultured chondrocytes
    • Kielpinski, G.; Prinzi, S.; Duguid, J.; Moulin, G. Roadmap to approval: use of an automated sterility test method as a lot release test for Carticel, autologous cultured chondrocytes. Cytotherapy 2005, 7 (6), 531-541.
    • (2005) Cytotherapy , vol.7 , Issue.6 , pp. 531-541
    • Kielpinski, G.1    Prinzi, S.2    Duguid, J.3    Moulin, G.4
  • 7
    • 59349086902 scopus 로고    scopus 로고
    • US Department of Health and Human Services; FDA; CDER; Center for Veterinary Medicine; Office of Regulatory Affairs. Guidance for Industry: PAT, A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. September 2004. Available at
    • US Department of Health and Human Services; FDA; CDER; Center for Veterinary Medicine; Office of Regulatory Affairs. Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. September 2004. Available at www.fda.gov/cder/OPS/PAT.htm.
  • 9
    • 0033927612 scopus 로고    scopus 로고
    • PDA. Technical Report 33: Evaluation, validation, and implementation of new microbiological methods. PDA J. Pharm. Sci. Technol. 2000, 54 (3) Supplement, 1-50.
    • PDA. Technical Report 33: Evaluation, validation, and implementation of new microbiological methods. PDA J. Pharm. Sci. Technol. 2000, 54 (3) Supplement, 1-50.
  • 11
    • 0000555764 scopus 로고    scopus 로고
    • Solid phase laser scanning cytometry: A new two-hour method for the enumeration of microorganisms in pharmaceutical waters
    • Jones, D. L.; Brailsford, M. A.; Droucourt, J.-L. Solid phase laser scanning cytometry: A new two-hour method for the enumeration of microorganisms in pharmaceutical waters. Pharmacopeial Forum 1999, 25 (1), 7626-7645.
    • (1999) Pharmacopeial Forum , vol.25 , Issue.1 , pp. 7626-7645
    • Jones, D.L.1    Brailsford, M.A.2    Droucourt, J.-L.3
  • 12
    • 0036326168 scopus 로고    scopus 로고
    • Validation of the Scan RDI for routine microbiological analysis of process water
    • Costanzo, S. P.; Borazzani, R.N.; McCormick, P. J. Validation of the Scan RDI for routine microbiological analysis of process water. PDA J. Pharm. Sci. Technol. 2002, 56 (4), 206-219.
    • (2002) PDA J. Pharm. Sci. Technol , vol.56 , Issue.4 , pp. 206-219
    • Costanzo, S.P.1    Borazzani, R.N.2    McCormick, P.J.3
  • 13
    • 59349119694 scopus 로고    scopus 로고
    • 25 Chapter 〈1223〉
    • USP, Rockville, MD: United States Pharmacopeial Convention
    • USP 25 Chapter 〈1223〉. Validation of Alternative Microbiological Methods. Rockville, MD: United States Pharmacopeial Convention.
    • Validation of Alternative Microbiological Methods
  • 14
    • 59349104435 scopus 로고    scopus 로고
    • EP 5.5. Alternative Methods for Control of Microbiological Quality. European Pharmacoepeia, July 2006, 50106, 4131-4142.
    • EP 5.5. Alternative Methods for Control of Microbiological Quality. European Pharmacoepeia, July 2006, 50106, 4131-4142.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.