We’re all aware of silicone quality concerns in primary containers. Drug product interactions can dewett silicone into solution over time – leading to subvisible particle issues, or worse yet device performance issues.
Reduce the risk with the latest generation of our Flex HD silicone inspection platforms. For the first time ever, you can easily see silicone with your own eyes.
The 100% non-destructive, quantitative analysis of our Flex HD is used to resolve silicone quality, quantity and distribution in nearly all primary containers for parenteral applications such as syringes, cartridges, and vials. Glass Containers | COC Container and Most Plastics – no issue!
Our Flex HD system is unique to the market as the system can be used on empty or filled containers. You’re empowered to closely monitor silicone mobility and dewetting into solution over time. Be it on stability or post stressing such as simulated distribution & handling (ASTM D4169, ISTA Series & ISO 11608).
No matter the application, the Flex HD can analyze sprayed on, baked on or crosslinked lubrication in seconds.
- 100% Non-Destructive Analysis of Silicone in Parenteral Containers
- Analyze filled or empty containers
- Easily Observe Lubricant Mobility
- Correlate Device Injection Performance to Distribution/Quantity
- Characterize Drug Product Particle Formation
- Set Supplier Specification to Reduce Risk
- Quantitative Results in Seconds!
ZebraSci’s experienced engineers are well versed in silicone quality issues. We can guide you to the best approach for monitoring silicone quality of an existing container or the strategy for selecting a new primary container. Contact us today to learn more about applications for Silicone Quality Inspection and our other solutions for ensuring primary container & device quality.