Advances in Deterministic Parenteral Container Closure Integrity

Time: 2:40 pm

Date: 1 May 2019

1-may-2019 14:40 1-may-2019 Europe/London Advances in Deterministic Parenteral Container Closure Integrity

This presentation outlines the challenges facing parenteral Container Closure Integrity (CCI) and recent developments in specific methods listed in USP 1207. The presentation will specifically explain the theory and application of the MicroCurrent HVLD, a next generation technology aimed at inspecting the integrity of a wide class of parenteral products and container formats. High voltage… Read more »

Making Pharmaceuticals

Synopsis

This presentation outlines the challenges facing parenteral Container Closure Integrity (CCI) and recent developments in specific methods listed in USP 1207. The presentation will specifically explain the theory and application of the MicroCurrent HVLD, a next generation technology aimed at inspecting the integrity of a wide class of parenteral products and container formats. High voltage leak detection is included in USP 1207 as a deterministic test methodology. The presentation will cover practical implementations, and present hard data in the use of High Voltage Leak Detection for parenteral products.

The MicroCurrent HVLD technology uses unique voltage and current characteristics to inspect parenteral products with a wide range of product characteristics. Traditional HVLD has proven to be an effective solution for parenteral class products, with the MicroCurrent HVLD increasing the range of liquids that can be tested, and improving the overall safety of the high voltage solution. The nature of MicroCurrent HVLD allows for testing packages containing liquids with extremely low conductivity, such as sterile water (WFI). MicroCurrent HVLD reduces voltage exposure of the product to less than 5% when testing with comparable HVLD solutions, greatly reducing the voltage exposure to the product and environment.

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