VOLTA High Voltage Leak Detection in Vials and Ampoules

VOLTA is a non-destructive benchtop instrument that uses high voltage discharge (HVLD) to analyse the integrity of containers/packaging filled with liquid. If a defect is detected in the container/packaging, VOLTA detects a sudden drop in resistivity and determines the failure of the integrity test. The instrument has extremely high sensitivity, less than 1 micron, and the sample holder adapts to different types of containers/packaging. The QESSE VOLTA is an excellent solution for detecting microcracks or pores that can compromise the sterility of packaging. It can be used to test:

• Vials
• Pre Filled Syringes
• Cartridges
• BFS containers
• IV Bags
• and others

The measuring principle: High voltage leak detection method exploits the electrical conductivity of a container made of non-conductive material filled with liquid. The high voltage is applied to the container by electrodes, and the signal is measured. If cracks or pinholes are present on the container wall, the system detects the change of impedance.

• Test Method: HVLD HIGH VOLTAGE LEAK DETECTION
• Type: Nondestructive
• Regulatory Standards:
  • USP <1207> Package Integrity Evaluation – Sterile Products
  • EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1, Manufacturer of Sterile Medicinal Products
• Results: Deterministic PASS/FAIL
• Limit: Adjustable limit values for PASS/FAIL
• Type: HVLD μE – micro Energy (typical below 100 mJ released to sample)
• HMI: 12” Touch Screen Windows base, by Siemens®
• PLC: Siemens®
• Test Sensitivity: Below 1 micron
• Sample: No sample preparation or conditioning before the test
• Recipe: Up to 15 different recipes
• Operation: One touch button with green/red indication of PASS/FAIL
• Software: CFR 21 PART 11 Compliant
• Data Storage: Unlimited
• Data: Data Export via USB or PC connection
• Network: RJ 45 Ethernet – OPC UA
• Dimensions: 380W x 600 L X 480 H [mm]
• Weight: 40Kg
• Power: 100-240 VAC; 50/60Hz
• Compliance: EMC 2014/30/UE, CE marked

• Non-destructive leak detection in containers.
• Detection of pores and micropores in vials, ampoules, and other types of containers.

USP <1207>
ASTM F2338-09
ASTM F2338-24
CFR21 part 11

Consult