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VOLTA High Voltage Leak Detection

VOLTA High Voltage Leak Detection
Product Description

QESSE HVLD is a nondestructive High Voltage Leak detection tabletop unit for package integrity testing on liquid filled containers (Vials, Pre Filled Syringes, Cartridges, BFS, IV Bags, etc.). Listed in the USP 1207 as deterministic method, allows to perform quantitative measurement of electrical current on the sample. It provides an indirect determination of leak presence and leak location as shown by a drop in test sample electrical resistivity, with a resultant increase in signal reading above a predetermined limit. The instrument has a high sensitivity, below 1 micron, and the sample support can be customized based on different containers. It is CFR 21 PART 11 compliant.

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Nordtest srl

  • IT
  • 2024
    On CPHI since
  • 3
    Certificates
  • 1 - 24
    Employees
Company types
Machinery and Equipment Supplier/Manufacturer
Primary activities
Laboratory, Analytical, Biotechnology Equipment
Packaging & drug delivery
Packaging materials
View company profile
Categories
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Specifications
  • Details
    • 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

  • Selling Points
    Packaging
  • Supplied from
    Italy
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Nordtest srl

  • IT
  • 2024
    On CPHI since
  • 3
    Certificates
  • 1 - 24
    Employees
Company types
Machinery and Equipment Supplier/Manufacturer
Primary activities
Laboratory, Analytical, Biotechnology Equipment
Packaging & drug delivery
Packaging materials
View company profile

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