The dimensional properties of any container or package system component plays a critical role in the overall qualification process. Component dimensional variability can impact the systems performance in any number of ways. The stack-up dimensions of a glass vial mouth / land seal and elastomeric stopper can influence the applied crimp force, directly impacting package integrity and leak potential. Inconsistent dimensions across screw-top containers and threaded closures provides another example of an integrity risk. Pre-filled syringe needle length, tip angle and diameter can alter the systems intended performance compromising patient use and safety. Many more examples exist. The ability to ensure dimensional accuracy and consistency on a lot to lot and component to component basis is critical.

To meet this critical demand, CS Analytical offers precise dimensional accuracy testing using advanced optical and digital measurement systems for a wide spectrum of container and package components to include:

  • Glass Bottles
  • Glass vials
  • Plastic Bottles
  • Elastomeric Closures
  • Elastomeric Plungers
  • Container Closure
  • Pre-Filled Syringes
  • Auto-Injectors
  • Medical Device Components
  • Needles
  • Needle Shields

Whether confirming dimensions from a client provided engineering specification sheets or creating a specification sheet for a newly produced lot of components, the CS Analytical digital measurement systems are fast – up to 99 dimensional points in less than 3 seconds -and highly accurate and precise – down 0.007 microns. The ability to take two dimensional measurements simultaneously across the X and Y axis enables a more robust approach when it comes to unique components qualification.

Whether you need whole lot verification, a critical dimensions measured on a small sample subset, or custom work performed as part of an investigation or package development process, our systems and technical staff have the experience and knowledge to assist with all dimensional testing requirements in a cGMP laboratory setting using validated systems.