WHY visual inspect of parenteral ? Clinic risk of visible particulates

YOU shall got the automatic visual inspection machine 

Welcome to attend Shandong Hawkeye Global Innitial launch of new ideas of Automatic visual inspection (AI)

Address: Yantai, Shandong .China

.......Visual detection of a particulate is a probabilistic process that depends on, among other things, the product and the

size and shape of the particulate (see United States Pharmacopeia General Chapter <1790> Visual Inspection of

Injections). Therefore, threshold studies should be conducted to determine the size of visible particulates that can be

reproducibly detected by trained personnel with near normal visual acuity. For more information about threshold

studies, see section IV in this guidance.

3 USP references in this guidance refer to USP 42–NF 37.

4 In general, subvisible particulates are those that cannot be seen with the naked eye. See USP General Chapters

<788> Particulate Matter in Injections and <787> Subvisible Particulate Matter in Therapeutic Protein Injections

for information about subvisible particulates control.

5 See, e.g., USP General Chapter <788>. .....

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The clinical manifestations of adverse events caused by particulate contamination vary and may

122 depend on the route of administration (e.g., intravascular, intravisceral, intramuscular), patient

123 population, and nature or class of the particulates themselves (e.g., physical size or shape,

124 quantity, chemical reactivity to certain cells or tissues, immunogenicity, infectivity,

125 carcinogenicity). Particulates in intravascular or intravisceral injections generally can cause more

126 adverse events than those in subcutaneous or intramuscular injections. According to published

127 case reports (Langille 2014; Doessegger et al. 2012), serious adverse events involving injectable

128 products contaminated with visible particulates have included:

129

•At the systemic level, infection and venous and arterial emboli (thrombotic or ...........