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.

Development of a validation protocol to determine the ability of screw-top containers to be watertight and to withstand impact damage from accidental dropping

“…This leak test involved removal of the tamper evident seal and re-closing of the lids but still the containers did not leak. Villalba et al (2004) tested MacoPharma CELLFLEX kits for their ability to withstand prolonged storage at temperatures of À808C and below and found that the containers could withstand the temperatures without deformation but that they were not air-tight, particularly in liquid nitrogen. They did not evaluate at other temperatures.…”

“…Few studies have reported on validations of tissue storage containers, Villalba et al (2004) noted that no standard test existed for this type of container. The methods used in this validation will be used in future NBS-TS validation tests of screw-top tissue containers.…”

“…of Health Code of Practice 2004) and internationally (European Association for Tissue Banking, Standards 2006) and containers are required to be CE marked (European Union, Medical Device Directive 93/42/EEC). Double containers must be used for tissue which is going to be frozen (Red Book, 2005, Villalba et al 2004). The container should be large enough to hold the tissue, it should be watertight, it should be able to withstand low temperatures (if applicable) and it should be able to withstand accidental dropping (Villalba et al 2004).…”

Technology in the Study of Production of Islamic Financial Institution Services at Bank Muamalat

“…There have been quite a lot of discussions related to services, but previous studies also had a different focus, one of the results being financial ratios(Alexandros A. Papantoniou 2022) in the form of CAR, ROA and ROA before and after Branchless Banking which were significantly different, while FDR was not significantly different. In-depth understanding of the value chain will provide a competitive advantage to improve performance and profits(R. Villalba et al 2004). To produce productive competition between Islamic Banks and Conventional Banks, banking regulations(Alina Tatarenko 2006) are needed specifically for Islamic Banking so that it is able to carry out its duties without having to follow the conventional system.…”