The Layer Explorer (LE) device determines the thickness and homogeneity of silicone oil layers for spray-on pre-filled syringes as well as baked-on cartridges and vials.
The robust Layer Explorer device determines the silicone oil layer quality parameters with ultra-high accuracy and reproducibility. The LE is notably successful in measuring baked-on silicone layers down to 20 nm thickness.
The Layer Explorer in just 10 years, has become the gold standard of siliconization testing of pre-filled syringes. The system has been successfully validated by more than 30 international pharmaceutical and medical device manufacturers.
Several studies have shown that the inhomogeneous distribution of silicone oil in pre-filled syringes can promote the release of silicone oil droplets into the formulation. They can now be classified by the updated USP chapters USP <1790> and USP <1787> as intrinsic particles. Silicone oil droplets could induce aggregation of the proteins to form formulation-inherent protein particles.
Homogeneous distribution of silicone is a critical factor for the function of a pre-filled syringe and even more critical of an auto-injector cartridge. Holes in the silicone layer will result in a higher force displacement. The spring of an auto-injector could be insufficiently strong and the plunger could stop, causing a malfunction of the injection device. Control over the siliconization before filling can save precious product and minimize the chance of stability issues.
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Tell good containers from bad containers before filling in your precious product. Syringe manufacturers ensure their product quality and establish quality parameters with their customers. In pharmaceutical manufacturing primary
packaging control delivers the valuable parameters for stability and homogeneity of the lubrication layer in bulk manufactured cartridges and nested pre-filled syringes.
The high accuracy of the system is ensured by certified traceable standards (Federal Seal), ensuring compliance with GMP and for worldwide standardized measurement results.
Superior Validation Data:
99% reproduceability on the scan line ±3% intermediate precision between 2 operators on 2 different days.