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USP1790里提到对于可见异物的检出概率的影响因素有几点,主要有产品粘度、灌装量、容器尺寸,容器形状和透明度,所以应该需要对这些受影响的因素进行评估,以确定同一规格不同产品做一次Knapp测试是否可行。USP原文如下:Upon 100% inspection, visible extrinsic and intrinsic particles should be reliably removed. Particle motion aids in detection, and stationary particles (due to neutral buoyancy or fill viscosity) are difficult to detect, exhibiting a significantly reduced PoD. The test method allows inherent particles to be accepted if the product appearance specification allows inherent particle types. PoD for all particles is dependent on the container characteristics (e.g., size, fill level, shape, and transparency), inspection conditions (lighting and duration), preparation characteristics (color and clarity), and particle characteristics (size, shape, color, and density). |
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