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Threshold study shows fiber color does not affect particle detectability in visual inspection, suggesting new training focus.
Visual inspection in pharmaceutical manufacturing and quality control ensures that products are "practically/essentially free" visible particles. The process relies on solid training and robust qualification programs for operators. Visual inspection is probabilistic, hence it is highly important to understand well the factors that define detectability of particles. Examples of such important factors are particle size, particle behaviour, primary packaging characteristics and properties of the product. This study aimed to assess the impact of one such factor - color - on the detectability threshold of fibrillar particles. Three types of colored fibers - two achromatic (black and white) and one chromatic (red), were used in a threshold study under compendial visual inspection conditions. The surprising and unexpected findings of the study demonstrate that contrary to conventional wisdom, fiber color does not appear to impact detectability.
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Fedorowicz et al. (2025) studied this question.
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