TR 2013/150: NovaPure 1mL Long 4023/50 Gray Plunger Container Closure Integrity Assessment

This report summarizes dye ingress and dynamic leak test results to assess CCI of Novapure 1 mL long plungers

Using Quality by Design (QbD) philosophy and principles, West developed a new FluroTec® barrier film laminated 1mL Long NovaPure® plunger, which was industrialized with a quality target product profile (QTPP) for container closure integrity (CCI) performance, and low dimensional part-to-part.

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