VOLTA

High Voltage Leak Detection

VOLTA is a nondestructive High Voltage Leak Detection (HVLD) bench top unit for package integrity testing of liquid filled containers.

In case of defect in the container with liquid inside, a clear drop of resistivity is detected by VOLTA and it causes a fail response. The instrument has a high sensitivity, below 1 micron, and the sample support can be customized based on different containers.

The QESSE VOLTA is the excellent solution for reliable detection of microcracks or pinholes affecting the sterility of containers. 

It can be used to test:

·        Vials

·        Pre Filled Syringes

·        Cartridges

·        BFS containers

·        IV Bags

·        and other

DOWNLOAD BROCHURE

Listed in the USP 1207 as a deterministic method, QESSE VOLTA is the ideal solution for Container Closure Integrity Testing.

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.

Specifications

  • 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