High Voltage Leak Tester for Ampoules and Bottles
Integrity testing of pharmaceutical packages, e.g. plastic containers, has always been an important phase of the manufacturing process.
Current FDA guidelines require validation for container closure integrity tests. EU GMP guidelines stipulate "Plastic ampoules should be subject to 100% integrity testing".
For smaller quantities, rommelag® offers a simple vacuum test chamber for integrity testing. Once the vacuum chamber has been loaded manually, a two-step vacuum cycle is performed. Subsequent to unloading, the ampoules are inspected visually by personnel.
rommelag®'s high voltage leak detector represents a testing method at high capacity, without risk of contamination of product and does not require human intervention. This HVLD leak detector operates based on the high voltage test method and the electrical conductivity of the fill product packaged in a non-conductive plastic ampoule. It is designed for fully-automatic in-line leak testing.
If any leak is present, the discharge current will flow through the pinhole into the container and the detection of this current will automatically cause the container to be rejected.
The machines consist of the following basic components: Ampoule feeding systems to the leak detector, transport system with product holders, switch for ampoule separation, inspection electrode(s), ampoule discharge system, machine guards, ozone exhaust system, electrical panel with all electrical inspection devices, PLC and color monitor.
Both testing methods are non-destructive procedures.
Production of leak detectors is also subject to the process in accordance with our quality control management system to DIN EN ISO 9001:2000 standard.