Research and Development, Canadian Blood Services, and The University of British Columbia Centre for Blood Research, Vancouver, British Columbia, Canada.
Transfusion. 2010 Oct;50(10):2240-8. doi: 10.1111/j.1537-2995.2010.02709.x. Epub 2010 Aug 16.
In high-volume processing environments, manual breakage of in-line closures can result in repetitive strain injury (RSI). Furthermore, these closures may be incorrectly opened causing shear-induced hemolysis. To overcome the variability of in-line closure use and minimize RSI, Fresenius Kabi developed a new in-line closure, the CompoFlow, with mechanical openers.
The consistency of the performance of the CompoFlow closure device was assessed, as was its effect on component quality. A total of 188 RBC units using CompoFlow blood bag systems and 43 using the standard bag systems were produced using the buffy coat manufacturing method. Twenty-six CompoFlow platelet (PLT) concentrates and 10 control concentrates were prepared from pools of four buffy coats. RBCs were assessed on Days 1, 21, and 42 for cellular variables and hemolysis. PLTs were assessed on Days 1, 3, and 7 for morphology, CD62P expression, glucose, lactate, and pH. A total of 308 closures were excised after processing and the apertures were measured using digital image analysis.
The use of the CompoFlow device significantly improved the mean extraction time with 0.46±0.11sec/mL for the CompoFlow units and 0.52±0.13sec/mL for the control units. The CompoFlow closures showed a highly reproducible aperture after opening (coefficient of variation, 15%) and the device always remained opened. PLT and RBC products showed acceptable storage variables with no differences between CompoFlow and control.
The CompoFlow closure devices improved the level of process control and processing time of blood component production with no negative effects on product quality.
在大容量处理环境中，手动打破在线封闭可能导致重复性劳损（RSI）。此外，这些封闭物可能会被错误地打开，导致剪切诱导的溶血。为了克服在线封闭使用的可变性并最小化 RSI，费森尤斯凯柏开发了一种带有机械开启器的新型在线封闭 CompoFlow。
评估了 CompoFlow 封闭装置的性能一致性及其对组件质量的影响。使用 CompoFlow 血袋系统生产了 188 个 RBC 单位，使用标准袋系统生产了 43 个 RBC 单位，均采用白细胞制造方法。从四个白细胞层制备了 26 个 CompoFlow 血小板（PLT）浓缩物和 10 个对照浓缩物。在第 1、21 和 42 天评估 RBC 的细胞变量和溶血。在第 1、3 和 7 天评估 PLT 的形态、CD62P 表达、葡萄糖、乳酸和 pH。处理后共切除 308 个封闭件，并使用数字图像分析测量孔径。
使用 CompoFlow 装置可显著提高平均提取时间，CompoFlow 单位为 0.46±0.11sec/mL，对照单位为 0.52±0.13sec/mL。CompoFlow 封闭件在打开后具有高度可重复的孔径（变异系数为 15%），且装置始终保持打开状态。PLT 和 RBC 产品的储存变量可接受，CompoFlow 和对照之间无差异。
CompoFlow 封闭装置提高了血液成分生产过程控制水平和处理时间，且对产品质量无负面影响。
