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

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 for therapeutic 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 (approximately 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.

journal_name

Cell Tissue Bank

journal_title

Cell and tissue banking

authors

Villalba R,Fornés G,Dueñas R,García A,Ariza A,Gómez-Villagrán JL

doi

10.1007/s10561-004-1090-3

keywords:

subject

Has Abstract

pub_date

2004-01-01 00:00:00

pages

267-9

issue

4

eissn

1389-9333

issn

1573-6814

pii

DO00001090

journal_volume

5

pub_type

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