메뉴 건너뛰기




Volumn 51, Issue 4, 2010, Pages 133-138

Environmental monitoring programme in the cell therapy facility of a research centre: Preliminary investigation

Author keywords

Cell therapy; Environmental monitoring; Good Manufacturing Practice (GMP)

Indexed keywords

AIR POLLUTION; AIRBORNE PARTICLE; ARTICLE; BACTERIAL LOAD; CELL THERAPY; COLONY FORMING UNIT; CONTROLLED STUDY; ENVIRONMENTAL MONITORING; LABORATORY; MEDICAL EDUCATION; MICROBIAL CONTAMINATION; NONHUMAN; REFERENCE VALUE; BACTERIAL COUNT; FUNGUS; GOOD MANUFACTURING PRACTICE; QUALITY CONTROL; SURFACE PROPERTY;

EID: 79953844517     PISSN: 11212233     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (18)

References (32)
  • 1
    • 0142094685 scopus 로고    scopus 로고
    • Current regulatory issues in cell and tissue therapy
    • DOI 10.1080/14653240310002324
    • Burger SR. Current regulatory issues in cell and tissue therapy. Cytotherapy 2003;5:289-98. (Pubitemid 37264995)
    • (2003) Cytotherapy , vol.5 , Issue.4 , pp. 289-298
    • Burger, S.R.1
  • 2
    • 79953857982 scopus 로고    scopus 로고
    • Medicinal Products for human and veterinary use 1998
    • European Commission Guide to Good Manufacturing Practices
    • European Commission Guide to Good Manufacturing Practices. Medicinal Products for human and veterinary use 1998 EudraLex vol. 4.
    • EudraLex , vol.4
  • 3
    • 79953877166 scopus 로고    scopus 로고
    • European Union Directive 2003/94/EC of 8 October 2003
    • European Union Directive 2003/94/EC of 8 October 2003.
  • 4
    • 79953893736 scopus 로고    scopus 로고
    • European Union Directive 2004/23/EC of the European Parliament and the Council of March 31 2004
    • European Union Directive 2004/23/EC of the European Parliament and the Council of March 31 2004.
  • 5
    • 79953873064 scopus 로고    scopus 로고
    • European Union Directive 2005/28/EC of 8 April 2005
    • European Union Directive 2005/28/EC of 8 April 2005.
  • 6
    • 79953845962 scopus 로고    scopus 로고
    • European Union Regulation 2004/726/EC of the European Parliament and of the Council of 31 March 2004
    • European Union Regulation 2004/726/EC of the European Parliament and of the Council of 31 March 2004.
  • 7
    • 79953886176 scopus 로고    scopus 로고
    • European Union Regulation 2007/1394/EC of the European Parliament and of the Council of 13 November 2007
    • European Union Regulation 2007/1394/EC of the European Parliament and of the Council of 13 November 2007.
  • 8
    • 0030690986 scopus 로고    scopus 로고
    • Good manufacturing practice production of human stem cells for somatic cell and gene therapy
    • Bosse R, Singhofer-Wowra M, Rosenthal F, et al. Good manufacturing practice production of human stem cells for somatic cell and gene therapy. Stem Cells 1997;15:275-80.
    • (1997) Stem Cells , vol.15 , pp. 275-280
    • Bosse, R.1    Singhofer-Wowra, M.2    Rosenthal, F.3
  • 9
    • 0029564216 scopus 로고
    • Quality assurance and good manufacturing practices for processing hematopoietic progenitor cells
    • McCullough J. Quality assurance and good manufacturing practices for processing hematopoietic progenitor cells. J Hematother 1995;4:493-501. (Pubitemid 26020552)
    • (1995) Journal of Hematotherapy , vol.4 , Issue.6 , pp. 493-501
    • McCullough, J.1
  • 10
    • 0346118840 scopus 로고    scopus 로고
    • Quality issues in stem cell and immunotherapy laboratories
    • DOI 10.1111/j.1365-3148.2003.00469.x
    • Smith L, Lowdell MW. Quality issues in stem cell and immunotherapy laboratories. Transfus Med 2003;13:417-423. (Pubitemid 37549039)
    • (2003) Transfusion Medicine , vol.13 , Issue.6 , pp. 417-423
    • Smith, L.1    Lowdell, M.W.2
  • 11
    • 0033801775 scopus 로고    scopus 로고
    • Production of stem-cell transplants according to good manufacturing practice
    • Bosse R, Kulmburg P, Von Kalle C, et al. Production of stem-cell transplants according to good manufacturing practice. Ann Hematol 2000;79:469-76.
    • (2000) Ann Hematol , vol.79 , pp. 469-476
    • Bosse, R.1    Kulmburg, P.2    Von Kalle, C.3
  • 14
    • 79953862150 scopus 로고    scopus 로고
    • Legislative Decree 211 Implementation of Directive 2001/20/EC, Rome
    • Legislative Decree 211 Implementation of Directive 2001/20/EC, Rome.
  • 17
    • 79953865150 scopus 로고    scopus 로고
    • European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
    • European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001.
  • 21
    • 0030817969 scopus 로고    scopus 로고
    • Moving towards a (microbiological) environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: A hypothesis, a practical programme, and some results
    • Hertroys R, Van Vught PA, Van De Donk HJ. Moving towards a microbiological environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: a hypothesis. PDA J Pharm Sci Technol 1997;51:52-59. (Pubitemid 27443534)
    • (1997) PDA Journal of Pharmaceutical Science and Technology , vol.51 , Issue.1 , pp. 52-59
    • Hertroys, R.1    Van Vught, P.A.M.2    Van De, D.H.J.M.3
  • 22
    • 0033936102 scopus 로고    scopus 로고
    • Design and operation of a current good manufacturing practices cell-engineering laboratory
    • Burger SR. Design and operation of a current good manufacturing practices cell-engineering laboratory. Cytotherapy 2000;2:111-122. (Pubitemid 30449428)
    • (2000) Cytotherapy , vol.2 , Issue.2 , pp. 111-122
    • Burger, S.R.1
  • 23
    • 33947633109 scopus 로고    scopus 로고
    • Environmental microbial contamination in a stem cell bank
    • DOI 10.1111/j.1472-765X.2006.02095.x
    • Cobo F, Concha A. Environmental microbial contamination in a stem cell bank. Lett Appl Microbiol. 2007;44:379-86. (Pubitemid 46496379)
    • (2007) Letters in Applied Microbiology , vol.44 , Issue.4 , pp. 379-386
    • Cobo, F.1    Concha, A.2
  • 24
    • 33644669140 scopus 로고    scopus 로고
    • Biological risk in the operatine room: Microbiological monitoring of the environment and analysis of the associated variables
    • Liguori G, Spagnoli G, Agozzino E, et al. Biological risk in the operatine room: microbiological monitoring of the environment and analysis of the associated variables. Annali di Igiene 2005;17:385-400.
    • (2005) Annali di Igiene , vol.17 , pp. 385-400
    • Liguori, G.1    Spagnoli, G.2    Agozzino, E.3
  • 25
    • 0343569987 scopus 로고    scopus 로고
    • Airborne viable particles and total number of airborne particles: Comparative studies of active air sampling
    • Ljungqvist B, Reinmuller B. Airborne viable particles and total number of airborne particles: comparative studies of active air sampling. PDA J Pharm Sci Technol 2000;54:112-6. (Pubitemid 30321140)
    • (2000) PDA Journal of Pharmaceutical Science and Technology , vol.54 , Issue.2 , pp. 112-116
    • Ljungqvist, B.1    Reinmuller, B.2
  • 28
    • 33644533550 scopus 로고    scopus 로고
    • Comparison of results of ATP bioluminescence and traditional hygiene swabbing methods for the determination of surface cleanliness at a hospital kitchen
    • DOI 10.1016/j.ijheh.2005.09.007, PII S1438463905001227
    • Aycicek H, Oguz U, Karci K. Comparison of results of ATP bioluminescence and traditional hygiene swabbing methods for the determination of surface cleanliness at a hospital kitchen. Int J Hyg Environ Health 2006;209:203-6. (Pubitemid 43292309)
    • (2006) International Journal of Hygiene and Environmental Health , vol.209 , Issue.2 , pp. 203-206
    • Aycicek, H.1    Oguz, U.2    Karci, K.3
  • 29
    • 0016537779 scopus 로고
    • Evaluation of bacteriological transport systems
    • Ederer GM, Christian DL. Evaluation of bacteriological transport systems. Am J Med Technol 1975;41:299-306.
    • (1975) Am J Med Technol , vol.41 , pp. 299-306
    • Ederer, G.M.1    Christian, D.L.2
  • 30
    • 79953891778 scopus 로고    scopus 로고
    • European Pharmacopoeia. Maisonneuve SA, Sainte Ruffine
    • European Pharmacopoeia. Sterility 2004. Maisonneuve SA, Sainte Ruffine.
    • (2004) Sterility
  • 31
    • 79953877165 scopus 로고    scopus 로고
    • General Chapter 71 2004 Sterility tests. USP 27-NF 22
    • United States Pharmacopoeia. Rockville, Maryland
    • United States Pharmacopoeia. General Chapter 71 2004 Sterility tests. USP 27-NF 22. In: US Pharmacopoeial convention. Rockville, Maryland, 2004, pp. 2157-2162.
    • (2004) US Pharmacopoeial Convention , pp. 2157-2162


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.