Siliconization Control

Control over the siliconization and lubrication

Lubrication is a critical quality aspect, (CQA) in pre filled syringes and cartridges. By using rap.ID’s control over the silicone layer, you may be able to  avoid costly recalls, as well as customer complaints. The control over siliconization ensures your  development and primary packaging department gain an insight into your syringe, cartridge or vial coatings.

siliconization control Lubrication in pre filled syringes and cartridges

Fast and efficient investigations

rap.ID provides you with traceable and comparable data on thickness, distribution and volume (weight) of silicone in syringes or baked-on cartridges. You can detect inadequate

 

thickness, uneven distribution or excess silicone which can cause gliding force issues or stability failures due to agglomerations seeded by silicone droplets.

 

Gain quickly data on critical quality aspects

As observed in many examples, silicone oil once applied forms not a static, but a rather dynamic layer. Re-distribution of silicone by gravity can be clarified. Therefore the age of a syringe has a big impact on product quality as well as other storage conditions. rap.ID services include investigations on: 

        • Primary packaging control for supplier comparison and packaging optimization
        • Stability, thickness and distribution – allows you to monitor the stability of your product in regard of lubrication and interaction with the formulation
        • Bulk process siliconization (baked-on) quality control and formulation interaction – provide valuable information on auto-injector reclamations and for siliconization process improvement

 

Silicone heat maps down to 20 nm layer thickness

We provide you with the thickness of silicone oil layers greater than 20 nm, on up to hundreds of different spots on your syringe, accurate to ±10 nm. Use our experienced

contract testing service and benefit from a 10 year matured technology and the measurement of more than 10.000 syringes and cartridges. You receive a reliable report in regards of  the thickness of the silicone oil layer inside your syringe. This information helps you optimize the amount of silicone oil used in your product and provides you with the optimal parameters for siliconization.