Functional Testing Summary Of Daikyo Crystal Zenith® Nested Vials With ISO Exterior Dimensions

The technical report summarizes the functional testing of Daikyo Crystal Zenith (CZ) nested vials designed to meet the exterior dimensions of glass standard ISO 8362-1. The vials are delivered sterile and ready to use and are designed for cold temperature storage. The report focuses on the characterization testing of the primary container closure system.

The functional testing of the vials included various tests to ensure their performance. Container closure integrity (CCI) testing was conducted at room temperature using helium flow. Low temperature conditioning over time and drop testing were also performed. The testing was conducted according to document-controlled test methods and standards.

The tests included Fragmentation, Penetration Force, Self Seal Capacity, and Spike Retention, as per USP<381> and USP<382> standards. Residual Seal Force (RSF) was also tested using an Instron Material Testing System. Additionally, an ink/label migration study was conducted to determine potential leaching from labels into the vials. Visual inspection was also performed to check for cracks or breakage.

The functional testing of the Daikyo Crystal Zenith nested vials has demonstrated that they meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions. The vials comply with USP<381> and USP<382> testing targets and pass additional tests. Further testing is pending for longer time points.