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Validation of orthopedic allograft preparation process: a new application of media fill test
Cell and Tissue Banking ( IF 1.5 ) Pub Date : 2023-09-20 , DOI: 10.1007/s10561-023-10107-y
Andrea Ossato 1 , Carlo Gasperoni 2 , Michela Stella 2 , Giulia Montagner 3 , Diletta Trojan 3 , Giuseppe Giovagnoni 4 , Michele Giannini 4 , Francesca Realdon 4 , Valeria Mezzadrelli 1 , Nicola Realdon 1 , Teresa Zuppini 4 , Roberto Tessari 4
Affiliation  

Musculoskeletal allografts represent an important practice in orthopedic surgeries and the demand for them has been growing. For this reason, in order to reduce clinical risk and to more efficiently manage the increase of allograft usage and also to optimize timing of the surgeries, the thawing and washing processes with aseptic technique were centralized in the department of Hospital Pharmacy. This study describe the design and execution of an adapted Media Fill Test (MFT) to demonstrate aseptic thawing and washing of allografts. For this specific and innovative setting, to better simulate the actual processing steps, a surrogate system was developed to simulate the tendon allograft. The aseptic technique of four operators was assessed and an initial performance validation and the first revalidation were described. All MFT were completed successfully, with no observation of turbidity. The readapted MFT shown in this study can provide insight into this innovative and growing field to other health professionals who want to implement this service.



中文翻译:

骨科同种异体移植物制备过程的验证:介质填充测试的新应用

肌肉骨骼同种异体移植是骨科手术的重要实践,对其的需求一直在增长。因此,为了降低临床风险、更有效地管理同种异体移植物使用的增加以及优化手术时机,采用无菌技术的解冻和清洗过程集中在医院药剂科。本研究描述了适应性培养基填充测试 (MFT) 的设计和执行,以演示同种异体移植物的无菌解冻和清洗。对于这种特定的创新设置,为了更好地模拟实际处理步骤,开发了替代系统来模拟同种异体肌腱。对四名操作员的无菌技术进行了评估,并描述了初始性能验证和第一次重新验证。所有 MFT 均成功完成,未观察到浑浊。本研究中显示的重新调整的 MFT 可以让其他想要实施这项服务的卫生专业人员深入了解这个创新和不断发展的领域。

更新日期:2023-09-21
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