Integrated Analytical And Functional Testing Support For Prefilled Syringes, Auto-injectors, Pen Injectors, And Related Combination Products

A combination product can pass one test and still fail another. Drug-contact materials, shipping stress, and device function all affect one another, yet they are often evaluated separately. This coordinated approach to prefilled syringes, auto-injectors, and pen injectors spans three areas: extractables and leachables studies covering silicone, elastomers, polymers, adhesives, and coatings; distribution and transit simulation, including pre- and post-distribution functional assessment and CCIT; and physical force testing such as break-loose and glide force, delivered volume, and needle guard lockout. It also shows where support fits across development, stability, method development, and shipping qualification.

Explore the testing scope to see how an integrated program could fit your path to market.