WHAT XEPICS DOES
A full portfolio of quality assurance solutions
• HeadSpace Analysis HSA
• Visual Inspection VI
• Container Closure Integrity Test CCIT
Equipment range
• Laboratory, In Process Control IPC
• Semi Automated
• Fully Automated
• Combination Systems
Product type
• Liquid
• Powder
• Lyophilized
HEADSPACE ANALYSIS
Non-destructive Non invasive monitoring of headspace gases
Applications
• Glass Packages ( molded, clear, amber)
• Plastic Packages optically non transparent to a NIR laser radiation
• Sterile parenteral products as O 2 sensitive Lyo under modified atmosphere or vacuum
Target: ensuring sterility and stability of product/package
• Confirm Container Closure Integrity
• Keep under control the primary packaging process (filling stoppering)
VISUAL INSPECTION
100% VI mandatory practice for injectable manufacturers to guarantee quality and patient safety
Applications:
• Package systems empty filled Vials, Bottles, Ampoules, Pre Filled Syringes, Cartridges
• Defects to be detected Foreign Contaminants ( Fibers), Cosmetic, Defective Caps and Closures, Fill Level, Product out of Specifications, Cracks
• Products Liquid, Powder, Lyophilized
Equipment:
• Laboratory (class A, B, C, D)
• Semi automated ( back‐to‐back inspection arrangement to double the inspection capacity feasible)
• Fully automated 200 and 400 containers per minute) combination with HSA and HVLD
CONTAINER CLOSURE INTEGRITY TEST
High Voltage Leak Detection (HVLD)
It exploits the electrical conductivity of the packaged liquid product in an electrically insulated container.
A high frequency voltage potential is applied to the package by means of two electrodes and the discharge current is measured.
If cracks or pinholes are present on the package surface, the circuit capacitance is decreased while the current flow between the electrodes is increased.
Applications:
• Package systems filled Vials, Bottles, Ampoules, Pre Filled Syringes, Cartridges, Blow Fill Seal BFS
• Products Liquid, conductive
• Material Glass and plastic
Equipment:
• Laboratory
• Fully automated 200 and 400 containers per minute)
• Combination with HSA and VI