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This technical report details the methodologies and criteria employed for the comprehensive CCI assessment on the West SmartDose® 10 cartridge assembly and piston, in accordance with the recommendations of USP <1207>.
This study involved microbial ingress testing and determination of a limit of detection, on CCSs that had undergone filling, packing, and shipping simulation. All samples tested for microbial ingress successfully showed no microbial growth. For limit of detection testing, 100 percent of samples with a 75-µm defect showed microbial growth, while 87 percent of the samples with a 5-µm defect showed growth.
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