A pharmaceutical company with limited device prefilled cartridge or device experience approached ZebraSci to support the development of a generic product

PRIMARY CONTAINER & DEVICE SELECTION AND EVALUATION

Timeline

Development activities were completed in 14 months after contract was signed.

Benefit

Company successfully launched their first product in a prefilled pen with no prior pharmaceutical or device experience.

ZebraSci led the following development activities:

  • Primary container and device selection consultation
  • Container closure integrity testing
  • Primary container & device test method development, functional testing, and documentation
  • Silicone distribution & functional stability testing
  • Final product lot release testing & established market complaint management program
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ZebraSci performs a wide array of functional and CCI methods to support lot release activities on syringes, pens, auto-injectors and vials