Pre-fillable syringes are normally siliconized using a spray-on siliconization process. The average silicone oil layer thickness (350 nm) is normally sprayed into a syringe using a diving or static nozzle depending on the siliconization process.
Excess silicone oil in a syringe can lead to the formation of silicone droplets or protein aggregation in protein based drugs. These types of issues force valuable biopharmaceutical drug products to be discarded. On the other hand, inadequate or missing silicone content can lead to high displacement forces or high “break out” forces that could make it difficult to administer the drug. Therefore, a homogeneous distribution with minimal silicone oil is advantageous.
The Layer Explorer (LE) is used by more than 90% of all glass syringe manufacturers worldwide to control and validate pre-fillable syringe manufacturing processes. Silicone layers in syringes can behave very dynamically exhibiting redistribution over time due to gravity. To ensure silicone layer functionality in Pre-Filled Syringes (PFS) before filling, many pharmaceutical companies employ the LE. TheLE provides a precise and detailed measurement of the silicone oil layer in pre-filled syringes down to 50 nm. Such detailed data enables the user to assign an effective “acceptance criteria” to primary packaging material.
Quality control of pre-fillable syringes received from vendors, e. g. sterile clean ready-to-fill
Optimization of spray siliconization in pre-fillable syringes manufacturing.
Pre-fillable Syringe development from glass or other materials such as COC
Control of the stability of silicone layers in pre-fillable syringes and polymer syringes
Quality Control of pre-fillable syringes manufacturing
This is a scan of 10 lines with 200 data points each. Red areas show a layer thickness of more than 600 nm, blue areas about 100 nm. The syringe in the example above was stored in a flat position, and therefore the migration of silicone oil is clearly visible.
