General safety guidances in stem cell bank installations

Cytotherapy

Volumn 8, Issue 1, 2006, Pages 47-56

  Cobo, Fernando ^a   Cabrera, C ^a   Catalina, P ^a   Concha, A ^a  

^a HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ALLERGENICITY; ARTICLE; CELL CULTURE; CONTROL STRATEGY; ECOTOXICITY; HEALTH CARE FACILITY; HEALTH PROGRAM; HUMAN; INFECTION RISK; MATERIALS HANDLING; MEDICAL RESEARCH; OCCUPATIONAL CARCINOGENESIS; OCCUPATIONAL HAZARD; OCCUPATIONAL HEALTH; OCCUPATIONAL SAFETY; PATHOGENICITY; PRACTICE GUIDELINE; PROTECTIVE CLOTHING; QUALITY CONTROL; REGENERATIVE MEDICINE; RISK ASSESSMENT; RISK FACTOR; STAFF TRAINING; STEM CELL BANK; TOXICITY;

GUIDELINES; HUMANS; SAFETY; SPECIMEN HANDLING; STEM CELLS; TISSUE BANKS;

EID: 33344474370     PISSN: 14653249     EISSN: None     Source Type: Journal    
DOI: 10.1080/14653240500505485     Document Type: Article

References (42)

1. National Institute of Health. Recommendations for the safe handling of cytotoxic drugs. Publication No. 92-2621. BethesdaMD, USA: National Institute of Health, Division of Safety, 1992.
2. Erickson, GA and Bolin, SR and Laundgraf, JD. (1991) Viral contamination of fetal bovine serum used for tissue culture: Risks and concerns Dev Biol Stand, 75, pp. 173 - 5.
3. Luka, J. (1988) Activation of Epstein-Barr virus in latently infected cell lines J Virol Methods, 21, pp. 223 - 7.
4. National Institute of Health. Guidelines for the laboratory use of chemical carcinogens. Publication No. 81-2385. USA: National Institute of Health, 1981.
5. National Institute of Health. Guidelines for research involving recombinant DNA molecules. Washington GPO, Federal Register 66 FR 1146. BethesdaMD, USA: National Institute of Health, 2001.
6. EEC. Directive of the protection of workers from the risks related to exposure to biological agents at work. European Commission Directive 90/ 679/EEC. EEC, Brussels, Belgium, 1990.
7. EEC. Indicative limit values. European Commission Directive 91/332/EEC. EEC, 1991.
8. EEC. The contained use of genetically modified microorganisms. Council Directive 98/81/EEC. EEC, 1998.
9. Jones, BPC.(1998) Laboratory practice. In Safety cell and tissue culture. (pp. 64 - 86). Dordrecht the Netherlands: Kluwer Academic Publishers.
10. CDC/NIH. Biosafety in microbiological and biomedical laboratories. In:RIchmondJY, McKinneyRW, eds, 4th edition. HHS Publication No. (CDC). US Department of Health and Human Services, Public Health Service, Centers for Disease Control and National Institute of Health.WashingtonDC: Government Printing Office, 1999:93-8395.
11. CDC/NIH. Primary containment for biohazards: Selection, installation and use of biological safety cabinets. In:RIchmondJY, McKinneyRW, editors. Department of Health and Human Services, Public Health Services, Centers for Disease Control and National Institute of Health. WashingtonDC: Government Printing Office, 2nd Edition, September 2000. pp 6-13.
12. Kennedy, DA and Collins, CH. (2000) Microbiological safety cabinets: selection, installation, testing and use Brit J Biomed Sci, 57, pp. 330 - 7.
13. Sewell, DL. (1995) Laboratory associated infections and biosafety Clin Microbiol Rev, 8, pp. 389 - 405.
14. UK MSBT. Guidance on the microbiological safety of human organs. Tissues and cells used in transplantation. UK: Advisory Committee on the Microbiological Safety of Blood and Tissues for Transplantation, London, England, 2000.
15. Takeuchi, H and Kobayashi, R and Hasegawa, M and (1996) Detection of latent infection by Epstein-Barr virus in peripheral blood cells of healthy individuals and in non-neoplastic tonsillar tissue from patients by reverse transcription-polymerase chain reaction J Virol Methods, 58, pp. 81 - 9.
16. Cassinotti, P and Burtonboy, G and Fopp, M and (1997) Evidence for persistence of human parvovirus B19 DNA in bone marrow J Med Virol, 53, pp. 229 - 32.
17. Fanci, R and De Santis, R and Zakrzewska, K and (2004) Presence of TT virus DNA in bone marrow cells from hematologic patients New Microbiol, 27, pp. 113 - 17.
18. US Food and Drugs Administration. CFR (Code of Federal Regulations) section 1271 Subpart C-suitability determination for donors of human cellular and tissue based products, proposed rule 64 FR 189. RockvilleMD: US Food and Drugs Administration, 30 September1999.
19. US Food and Drugs Administration. CFR (Code of Federal Regulations). Title 21, volume 8. Part 1271, Human cells, tissues, and cellular and tissue-based products. RockvilleMD: US Food and Drugs Administration, April 1 2003.
20. Nicklas, W and Kraft, V and Meyer, B. (1993) Contamination of transplantable tumors, cell lines, and monoclonal antibodies with rodent viruses Lab Anim Sci, 43, pp. 296 - 300.
21. Mahy, BW and Dykewicz, C and Fisher-Hoch, S and (1991) Virus zoonoses and their potential for contamination of cell cultures Dev Biol Stand, 75, pp. 183 - 9.
22. European Medicines Evaluation Agency. Note for guidance on quality of biotechnological products: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. CPMP/ICH/295/ 95. LondonUK: European Medicines Evaluation Agency, 1997. http://www.eudra.org/emea.htmlMay 15, 2005.
23. Wolfe, ND and Heneine, W and Carr, JK and (2005) Emergence of unique primate T-lymphotropic viruses among central African bushmeat hunters Proc Natl Acad Sci USA, 102, pp. 7994 - 9.
24. Srinivasan, A and Burton, EC and Kuehnert, MJ and (2005) Transmission of rabies virus from an organ donor to four transplant recipients N Engl J Med, 352, pp. 1103 - 11.
25. National Committee for Clinical Laboratory Standards. Protection of laboratory workers from infectious diseases transmission by blood, body fluids and tissue. Tentative Guidelines M29-T2, 11, no. 14. National Committee for Clinical Laboratory Standards Wayne, PA, USA, 1991.
26. National Institute of Health. Guidelines for Research Involving Recombinant DNA molecules. Federal Register 59 FR 34496. Washington GPOFederal Register, Washington, DC, USA, 1998.
27. Advisory Committee on Dangerous Pathogens.(1995) Categorisation of biological agents according to hazard and categories of containment 4th edition. Sudbury: HSE Books.
28. British Standard Institution. Biotechnology: Performance criteria for microbiological safety cabinets. BS EN 12469. LondonUK: British Standards Institution, 2000.
29. Tedder, RS and Zuckerman, MA and Goldstone, AH and (1995) Hepatitis B transmission from contaminated cryopreservation tank Lancet, 1346, pp. 137 - 140.
30. Directive 2004/23/CE of the European parliament and the council of March 31st, relating to the establishment of quality and safety norms to donation, to obtain, to assess, to processation, to preservation, to storage and to distribution of human cell and tissues.European Parliament Council. European Union Official Diary, Brussels, Belgium.
31. Department of Health and Human Services. Additional requirements for facilities transferring or receiving select agents. Rule 42 CFR, part 72, Federal Register, Washington, DC, USA, 1997.
32. Fleming, DO.(1995) Laboratory biosafety practices. In Laboratory safety: principles and practices2nd edition. (pp. 203 - 18). Washington DC: American Society for Microbiology.
33. Collins, CH.(1993) Laboratory-acquired infections: History, incidence, causes, and prevention 3rd edition. Oxford: Butterworth-Heinemann Ltd.
34. Hanel, E, Jr and Halbert, MM.(1986) Pipetting. In Laboratory safety: principles and practices. (pp. 204 - 14). Washington DC: American Society for Microbiology.
35. Kruse, RH and Puckett, WH and Richardson, JH. (1991) Biological safety cabinetry Clin Microbiol Rev, 4, pp. 207 - 41.
36. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens: Final rule. U.S Department of Public Health. Washington, DC, USA. Federal Register56, 1991:64003-182.
37. Richardson, JH and Gershon, RRM.(1994) Safety in the clinical microbiology laboratory. In Clinical and pathogenic microbiology2nd edition. (pp. 37 - 45). St Louis MO: Mosby-Year Book Inc.
38. Jagger, J and Detmer, DE and Cohen, ML and (1992) Reducing blood and body fluid exposures among clinical laboratory workers Clin Lab Manag Rev, 6, pp. 415 - 24.
39. Nettleman, MD and Fredrickson, M and Good, NL and (1994) Tuberculosis control strategies: The cost of particulate respirators Ann Intern Med, 121, pp. 37 - 40.
40. Strain, BA and Groschel, DHM.(1995) Laboratory safety and infections waste management. In Manual of clinical microbiology6th edition. (pp. 75 - 85). Washington DC: American Society for Microbiology.
41. Vesley, D and Laver, J.(1995) Decontamination, sterilization, disinfection and antisepsis. In Laboratory safety: Principles and practices2nd edition. (pp. 219 - 37). Washington DC: American Society for Microbiology.
42. National Committee for Clinical Laboratory Standards. Clinical laboratory waste management. Approved document GP5-A. VillanovaPA: National Committee for Clinical Laboratory Standards, 1993.