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Evaluation and utility of new CE marked containers (CELLFLEX- MacoPharma) for bone bank

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Abstract

In order to guarantee the required level of quality for our Bone & Tissue Banking, we evaluated a new CE marked container (CELLFLEX MacoPharma), for packing, transport, processing and storage of bones fortherapeutic use. The use of CE marked containers is mandatory for organ and tissue containers (Medical Device Directive 93/42).

We carried out a three-phase study:

(1)Evaluation, (2)Implementation, (3)Audit

The product was evaluated for the following criteria:

Dash mechanical resistance, Dash air tightness, Dash fragility, Dash capacity.

No damage was observed after the storage period, even after immersion in liquid nitrogen. No breakages were observed after provoked impact tests (pots dropped onto the floor). The pot capacity evaluation showed that the inner pot volume (∼500 ml) permits adequate storage of tendons and the majority of bone allografts.

In conclusion, this evaluation has shown that the CELLFLEX kit is suitable for long duration preservation of bone allografts even at very low temperature conditions (vapour phase nitrogen). Its format and structure permit preservation of most bone allografts.

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References

  • AEBT 2001. Esta ´ndares de la Asociacio ´n Española de Bancos de Tejidos.

  • EATB 2003. General Standars for Tissue Banking. European Association of Tissue Banks.

  • Farrington M., Tedder R., Kibbler C., Wreghitt T., Gould K. and Tremlett C. H. 1999. Pre-transplantation testing:who, when and why. J. Hosp. Infect. 43S:243–252.

    Article  Google Scholar 

  • Kearney J. N. 1998. Quality issues in skin banking:a review. Burns 24:299–305.

    Article  PubMed  CAS  Google Scholar 

  • Klen R. 1976. Tissue banking in Czechoslovakia. Transplant Proc. 8:49–51.

    PubMed  CAS  Google Scholar 

  • Komender J. 1974. The activity and research programme of the tissue bank in Warsaw. Acta Chir. Plast. 16:122–123.

    PubMed  CAS  Google Scholar 

  • Von Versen R. 1999. Musculoskeletal tissue banking in Europe –regulations and quality assurance. Ann. Chir. Gynaecol. 88: 215–220.

    PubMed  CAS  Google Scholar 

Download references

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Authors and Affiliations

  1. Centro Regional de Transfusion Sanguínea, Avda. San Alberto Magno s/n, Córdoba, 14004, Spain

    R. Villalba, G. Fornés, R. Dueñas, A. García, A. Ariza & J.L. Gómez-Villagrán

Authors
  1. R. Villalba
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  2. G. Fornés
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  3. R. Dueñas
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  4. A. García
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  5. A. Ariza
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  6. J.L. Gómez-Villagrán
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Villalba, R., Fornés, G., Dueñas, R. et al. Evaluation and utility of new CE marked containers (CELLFLEX- MacoPharma) for bone bank. Cell Tissue Banking 5, 267–269 (2004). https://doi.org/10.1007/s10561-004-1090-3

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  • DOI: https://doi.org/10.1007/s10561-004-1090-3

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