The Leak Test Samples (LTS) are designed and manufactured to provide a reference sample for leak testing equipment. This is required to meet the compendial requirements for performing Container Integrity Testing of parenterals, as per USP, EP and JP.
The main characteristic of the Leak Test Samples is that they contain a 10 micron pinhole in one of three possible positions. The 10 micron pinhole diameter was chosen since it is the diameter that can be readily detected when using the blue dye test – the compendial reference method.
Pinholes created have the following characteristics:
- Drilled using ultra-precision laser technology;
- Each sample is verified by flow measurement
- optionally Scanning Electron Microscopy can be applied to demonstrate correlation between flow of the pressure-decay and the diameter of the pinhole.
Each Leak Test Sample is delivered:
- In a carton box, preventing breakage under normal conditions
- With a datasheet of measured flow – and theorethical indication of pinhole diameter
Since high-precision laser drilling is used we can produce virtually any pinhole size. Due to fluctuations in glass or plastic thickness and composition it might not be possible to repeatedly produce samples with exactly the same pinhole diameter.
The LTS’s are manufactured with extreme care. We request our customers to provide us with the containers they expect us the produce samples from. It is also at customer’s discretion to choose a nominal pinhole diameter.
In principal any container type (ampoules, vials, syringes, cartridges or carpoules) and any container material (glass or plastic) can be transformed into a Leak Test Sample. Please send us only empty containers or placebo’s. Handling of containers containing Active Substances may result in additional cost.
The datasheet of either sample will contain a flow measurement .