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In order to determine the possibility of making this change we have had samples tested from various batches of sterile vials one of which was six years old, another five years old.
The sterile glass vials were tested for sterility, endotoxins and internal pressure.
The results show that 100% of the samples tested were found to be sterile, apyrogenic and had retained an internal under pressure in line with the specification.
The type of components used in the VNS10 sterile glass vials assembly are widely used in the pharmaceutical industry and compatibility of the components with each other has hence been demonstrated in a variety of applications.
Based on the results and empirical evidence the expiry date for the VNS10 sterile vials has been extended from two to three years and this will take effect for all new manufactured batches.
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