Bacterial contamination of ex vivo processed PBPC products under clean room conditions

Transfusion

Volumn 43, Issue 11, 2003, Pages 1587-1595

  Ritter, Markus ^a   Schwedler, Joachim ^b   Beyer, Jörg ^b   Movassaghi, Kamran ^b   Mutters, Reinier ^b   Neubauer, Andreas ^b   Schwella, Nimrod ^b  

^a PHILIPPS UNIVERSITY MARBURG   (Germany)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADOLESCENT; ADULT; AGED; ALLOGRAFT; ARTICLE; AUTOTRANSPLANTATION; BACTERIAL COLONIZATION; BACTERIUM CONTAMINATION; BACTERIUM CULTURE; CENTRAL VENOUS CATHETER; CHILD; FEMALE; GOOD MANUFACTURING PRACTICE; HUMAN; HUMAN CELL; IMMUNE DEFICIENCY; INFECTION RISK; LEUKAPHERESIS; MAJOR CLINICAL STUDY; MALE; MICROBIAL GROWTH; NONHUMAN; POLYMORPHONUCLEAR CELL;

BACTERIA; BACTERIOLOGICAL TECHNIQUES; BLOOD CELLS; CELL SEPARATION; ENVIRONMENT, CONTROLLED; HUMANS; LEUKAPHERESIS; STEM CELLS; TIME FACTORS;

EID: 0242608338     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.2003.00573.x     Document Type: Article

References (23)

1. Attarian H, Bensinger WI, Buckner CD, et al. Microbial contamination of peripheral blood stem cell collections. Bone Marrow Transplant 1996;17:699-702.
2. Jestice HK, Farrington M, Hunt C, et al. Bacterial contamination of peripheral blood progenitor cells for transplantation. Transfus Med 1996;6:103-10.
3. Webb IJ, Coral FS, Andersen JW, et al. Sources and sequelae of bacterial contamination of hematopoietic stem cell components: implications for the safety of hematotherapy and graft engineering. Transfusion 1996;36:782-8.
4. Espinosa MT, Fox R, Greger RJ, et al. Microbiologic contamination of peripheral blood progenitor cells collected for hematopoietic cell transplantation. Transfusion 1996;36:789-93.
5. Schwella N, Zimmermann R, Heuft HG, et al. Microbiologic contamination of peripheral blood stem cell autografts. Vox Sang 1994;67:32-5.
6. Perez P, Salmi LR, Follea G, et al. Determinants of transfusion-associated bacterial contamination: results of the French BACTHEM Case-Control Study. Transfusion 2001;41:862-72.
7. Schwella N, Rick O, Heuft HG, et al. Bacterial contamination of autologous bone marrow: reinfusion of culture-positive grafts does not result in clinical sequelae during the posttransplantation course. Vox Sang 1998;74:88-94.
8. German drug act of the Federal Republic of Germany, 10th amending law. Fed Law Gazette 2000 Jul;4:1002.
9. Guide to the Good Manufacturing Practice. Vol. 4. Drugs for human beings and animals (Internet). Brussels: European Commission; 1999. Available from: http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm
10. Annex I to the European Union (EU)-GMP-guidelines to production of sterile drugs. Brussels: European Union; 1999. Available from: http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/revan1vol4_2.pdf
11. Ritter M, Mutters R, Schwella N, et al. Preparation of blood stem cell concentrates under clean room conditions A with background conditions B. Pharm Ind 2002;64:601-6.
12. Ritter M, Mutters R, Schwella N, et al. Preparation of blood stem cell concentrates under clean room conditions A with background conditions B. Pharm Ind 2002;64:701-7.
13. Fundamentals of an environmental monitoring program. Technical Report No. 13. Revised. Parenteral Drug Association. PDA J Pharmaceut Sci Technol 2001;55:1-35.
14. Cassens U, Ahlke C, Garritsen H, et al. Processing of peripheral blood progenitor cell components in improved clean areas does not reduce the rate of microbial contamination. Transfusion 2002;42:10-7.
15. Perez P, Bruneau C, Chassaigne M, et al. Multivariate analysis of determinants of bacterial contamination of whole-blood donations. Vox Sang 2002;82:55-60.
16. Lee CK, Ho PL, Chan NK, et al. Impact of donor arm skin disinfection on the bacterial contamination rate of platelet concentrates. Vox Sang 2002;83:204-8.
17. Gibson H, Norris W. Skin fragments removed by injection needles. Lancet 1958;2:983-5.
18. de Korte D, Marcelis JH, Verhoeven AJ, et al. Diversion of first blood volume results in a reduction of bacterial contamination for whole-blood collections. Vox Sang 2002;83:13-6.
19. Bruneau C, Perez P, Chassaigne M, et al. Efficacy of a new collection procedure for preventing bacterial contamination of whole-blood donations. Transfusion 2001;41:74-81.
20. Ziegler R, Johnscher I, Martus P, et al. Controlled clinical laboratory comparison of two supplemented aerobic and anaerobic media used in automated blood culture systems to detect bloodstream infections. J Clin Microbiol 1998;36:657-61.
21. Jorgensen JH, Mirrett S, McDonald LC, et al. Controlled clinical laboratory comparison of BACTEC plus aerobic/F resin medium with BacT/Alert aerobic FAN medium for detection of bacteremia and fungemia. J Clin Microbiol 1997;35:53-8.
22. Welby PL, Zusag TM, Storch GA. Comparison of the Bactec Peds Plus pediatric blood culture vial with Roche pediatric Septi-Chek for blood cultures from pediatric patients. J Clin Microbiol 1992;30:1361-2.
23. Weinstein MP, Mirrett S, Wilson ML, et al. Controlled evaluation of 5 versus 10 milliliters of blood cultured in aerobic BacT/Alert blood culture bottles. J Clin Microbiol 1994;32:2103-6.