PRIMARY CONTAINER CHARACTERIZATION
One of the many variables that contribute to drug delivery device reliability is the primary container itself. With our experience with the containers and components from the world’s leading manufacturers, we can assist you with selecting the right components or optimizing your device to an existing container. Leverage our knowledge, experience and partnerships to be well informed for your next primary container decision.
ZebraSci pioneered the development of inspection equipment to analyze the lubricant coating quality within syringes, cartridges and other primary containers. Today, our FLEX systems can fully characterize the lubricant coating quality of primary containers, quantifying the lubricant oil distribution within product filled and empty syringes or cartridges. The data captured can then be correlated to injection force and be used to predict device reliability. This non-destructive evaluation can be further used to analyze lubricant mobility over time.
While developing inspection systems for lubricant distribution and siliconization in primary packaging used in medical devices, the engineers at ZebraSci determined that there are a number of additional factors that affect the force required to deliver the amount of drug from a primary container such as a syringe or cartridge. These critical parameters must be evaluated and characterized during the development of the drug delivery device system to ensure reliable and successful delivery of drug product to the end user.
CRITICAL CONTAINER CHARACTERIZATION:
- Container Critical Dimensions (sub 10 micron accuracy)
- Lubricant Distribution / Siliconization
- Needle Inner Diameter via Hydrodynamic Friction
- Container Barrel Inner Diameter
- Plunger Composition and Dimensions
- Container Piston/Plunger Positioning
- Break loose and Glide Force, simulating product in use
- MFI for sub-visible Particles
- Drug Product Viscosity
- Injection Time and Injection Depth
- Injection Velocity
TYPICAL CHARACTERIZATION PROGRAMS INCLUDE EVALUATION OF NUMEROUS VARIABLES:
Many variables contribute to drug delivery device reliability – be it injection success, dose accuracy or even patient adherence. The team at ZebraSci can assist you with all the pieces of the puzzle. Our test reports and data packages provide analysis of the all the measured variables, giving you confidence in your drug delivery device – anything from an of the shelf PFS to novel injector systems.
|Friction of Barrel||Primary Container Barrel Inside Diameter|
|Friction of Barrel||Primary Container Lubrication/Siliconization|
|Friction of Barrel||Needle Free Glide Force|
|Friction of Plunger||Plunger Outside Dimension|
|Drug Friction||Needle Inside Diameter|
|System Friction||Glide Force|
|Dimensions||Primary Container Exterior Dimensions (including syringe flange)|
|Drug Product Friction||Viscosity at different shear rates to observe non-Newtonian effects|
Contact ZebraSci today to learn more about our drug delivery and combination product development solutions.