Leak Detction

---

Container integrity is one of the major concerns when it comes to patient's safety. Invisible leakages like cracks of microscopic dimensions or pinholes in the container weaken the mechanical properties and put sterility of product at risk. Container like ampoules and vials are mostly have to be checked for closure defects, cracks and scratches. There are variety of methods used within the pharmaceutical industry for the detection of pinholes, cracks and defective seals in various pharmaceutical packaging. Based on the guidance document of container closure integrity, the clear direction towards more reliable test methodology and techniques to test for physiochemical package integrity characteristics. Well-validated, adequately sensitive physical test method are permitted and preferred, such as High Voltage Leak Detection(HVLD), Pressure Decay Leak Detection(PDLD) and Headspace Gas Analysis(HGA) etc.

There are variety of methods used within the pharmaceutical industry for the detection of pinholes, cracks and defective seals in various pharmaceutical packaging.

Based on the guidance document of container closure integrity, the clear direction towards more reliable test methodology and techniques to test for physiochemical package integrity characteristics.

Well-validated, adequately sensitive physical test method are permitted and preferred, such as High Voltage Leak Detection(HVLD), Pressure Decay Leak Detection(PDLD) and Headspace Gas Analysis(HGA) etc.