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APPLICATION OF KRACTOGRAPHY IN PHARMACEUTICAL INDUSTRY

机译：断层照相术在医药工业中的应用

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Fractographic investigations were conducted on a glass syringe complaint specimen with breakage at its cone end. The aim of the investigation was to determine whether failure occurred due to mechanical overload or due to unusual damage which led to breakage at moderate mechanical loadings. For this purpose, controlled cone-strength investigations and fracture-mirror size analysis were conducted on the fracture surfaces of reference syringe specimens. From this, an empirical constant of the cone-strength force versus the fracture-mirror size ("syringe mirror constant") was deduced. With these results a comparison of the mirror-mist radii of the reference specimens with the complaint specimen was possible. From Orr's equation it is known that low mechanical loadings create large mirror-mist radii, and vice versa. As the mirror-mist radii of the complaint sample are much greater than for the reference samples, it is deduced that the breakage force for the complaint sample must have been much smaller than the specification level for this syringe. This conclusion is supported by the fact that severe damage is observed in the vicinity of the fracture origin of the complaint sample. It is thus concluded that failure occurred due to damage which was introduced somewhere during hot forming of the glass, syringe assembly, filling, or packaging. This result acquits the syringe operator (e.g., patient or health care staff) from responsibility and shifts it to contributors of the value added chain (e.g., syringe manufacturer, pharmaceutical company, contract fillers or labelers).
机译：对玻璃注射器投诉标本进行了分形研究，标本的圆锥形端部有破损。研究的目的是确定故障是由于机械过载还是由于异常损坏而导致的，这些异常损坏导致在中等机械负载下破裂。为此，在参考注射器标本的断裂表面上进行了受控的锥强度研究和断裂镜尺寸分析。由此得出锥强度与断裂镜尺寸的经验常数（“针镜常数”）。利用这些结果，可以比较参考样本的镜雾半径和主诉样本的镜雾半径。从Orr方程中可以看出，低机械载荷会产生较大的镜雾半径，反之亦然。由于投诉样品的镜面半径远大于参考样品的镜面半径，因此可以推断出投诉样品的断裂力必须比该注射器的规格水平小得多。这一结论得到以下事实的支持：在投诉样品的骨折起点附近观察到严重损坏。因此得出的结论是，由于玻璃热成型，注射器组装，填充或包装过程中某处引入的损坏而导致发生故障。该结果使注射器操作员（例如，患者或医护人员）免于承担责任，并将其转移到增值链的贡献者（例如，注射器制造商，制药公司，合同灌装商或贴标签商）。

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