container closure integrity of smartdose 3.5 injector
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TR 2018190: Container Closure Integrity Assessment of the SmartDose® 3.5 Injector

Summary of CCI testing in alignment with USP<1207> on the Smart Dose 3.5 Injector including a Crystal Zenith (CZ) cartridge and Daikyo D21-6-1 Flurotec laminated piston.
Testing included high voltage leak detection (HVLD) and methylene blue dye testing. Samples were filled using a modified Bausch+Stroebel flexible filler, KCP 5060. All samples met acceptance criteria.
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