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.
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 colour monitor. The testing methods is a non-destructive procedures.
rommelag's high voltage leak detector type HVLD 924 has a capacity up to 6,000 single containers per hour. The technical specifications are in the chart below.
Technical Data HVLD type 924:
| || With one (1) test station || With two (2) test stations |
| Width: || 3,000 mm || 3,000 mm |
| Length: || 3,000 mm || 3,000 mm |
| Height: || 2,300 mm || 2,300 mm |
| Weight: || 1,500 kg ||2,000 kg |
| Capacity: || up to 6,000 ampoule blocks per hour |
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