Bottle Leak Testing Machine
Choosing the right bottle leak testing machine is key when developing and packaging drugs into plastic containers as the smallest contamination can affect the integrity of the tablets, capsules, powder or liquid that are being stored inside.
The Sepha Multi-Q is a non-destructive and deterministic CCIT solution that can identify gross holes and micro leaks down to 5 micron in a range of plastic bottles.
Depending on the content of the container, the system can work in combination with vacuum and pressure decay test methods, making it the ideal solution for stability testing, clinical trials, or in-process quality control testing.
The Sepha Multi-Q can be used for testing cap screw bottles (including child resistant closures), droppers, ointment jars, vials etc. in different shapes and sizes. Once it has been established the container has sufficient gas headspace, our expert teams of engineers will design tooling and a method in line with the desired sensitivity requirements.
We have an extensive tooling library for standardised container sizes and can develop custom tooling for more complex bottles to ensure the container fits the test chamber with a tight tolerance. This is important as it reduces the head space within the vacuum chamber, resulting in a more accurate and robust test method.
More information on the bottle leak testing machine including 21 CFR Part 11 capability, USP 1207 and FDA approved ASTM F2338-09 standard test method is available via the link below.