Document Detail


Cleanrooms and tissue banking how happy I could be with either GMP or GTP?
MedLine Citation:
PMID:  23288450     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
J Klykens; J-P Pirnay; G Verbeken; O Giet; E Baudoux; R Jashari; A Vanderkelen; N Ectors
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-4
Journal Detail:
Title:  Cell and tissue banking     Volume:  -     ISSN:  1573-6814     ISO Abbreviation:  Cell Tissue Bank     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100965121     Medline TA:  Cell Tissue Bank     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Cell and Tissue Banks, University Hospitals Leuven, UZ Gasthuisberg, Herestraat, 49, 3000, Leuven, Belgium, johan.klykens@uzleuven.be.
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