Do yo routinely test for the silicone oil in your DP when filled in siliconised prefilled syringes? If so, what analytical method do you use?
Siegfried SchmittLevel 1
silicone oil for siliconised prefilled syringes testing
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The quantification of silicone oil is required as qualification test, not in routine. On routine level, Pharmacopoeias recommend the syringibility test, in which, through a dynamometric system, the initial force to move the stopper (Break off force) and to move it along the glass barrel (glide force) is calculated. These forces are compared to the force of patient during injection (normally not more 16N) and are a clear evidence of siliconization quantity and homogeneous distribution.
Thank you very much for your reply Elisabetta