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Cell and Tissue Banking

, Volume 14, Issue 4, pp 571–578 | Cite as

Cleanrooms and tissue banking how happy I could be with either GMP or GTP?

  • J. Klykens
  • J.-P. Pirnay
  • G. Verbeken
  • O. Giet
  • E. Baudoux
  • R. Jashari
  • A. Vanderkelen
  • N. Ectors
Original Paper

Abstract

The regulatory framework of tissue banking introduces a number of requirements for monitoring cleanrooms for processing tissue or cell grafts. Although a number of requirements were clearly defined, some requirements are open for interpretation. This study aims to contribute to the interpretation of GMP or GTP guidelines for tissue banking. Based on the experience of the participating centers, the results of the monitoring program were evaluated to determine the feasibility of a cleanroom in tissue banking and the monitoring program. Also the microbial efficacy of a laminar airflow cabinet and an incubator in a cleanroom environment was evaluated. This study indicated that a monitoring program of a cleanroom at rest in combination with (final) product testing is a feasible approach. Although no statistical significance (0.90 < p < 0.95) was found there is a strong indication that a Grade D environment is not the ideal background environment for a Grade A obtained through a laminar airflow cabinet. The microbial contamination of an incubator in a cleanroom is limited but requires closed containers for tissue and cell products.

Keywords

Clean room Tissue banking Laminar airflow cabinet Incubator GMP GTP Microbial Particle Monitoring Controlled environment 

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Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • J. Klykens
    • 1
  • J.-P. Pirnay
    • 2
  • G. Verbeken
    • 2
  • O. Giet
    • 3
  • E. Baudoux
    • 3
  • R. Jashari
    • 4
  • A. Vanderkelen
    • 2
    • 4
  • N. Ectors
    • 1
  1. 1.Cell and Tissue BanksUniversity Hospitals LeuvenLeuvenBelgium
  2. 2.Cell and Tissue BanksQueen Astrid Military HospitalBrusselsBelgium
  3. 3.Cell and Tissue BanksUniversity Hospital LiègeLiègeBelgium
  4. 4.European Homograft BankBrusselsBelgium

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