Insulin Project III


Client: Eli Lilly
Florence, Italy
Pharmaceutical, Fill-Finish Facility

Project Highlights

Installation a new RABS Filling line and production equipment in a new sterile production area at Sesto Fiorentino. Project replicated in other Eli Lilly sites worldwide.

Services Summary

C&Q Lead for the Start-up, Commissioning and Qualification of Sesto project and participation into the global C&Q team for the strategy definition.

  • Define the Global CQV Strategy for the Global Insulin Cartridge Program.
  • C&Q schedule development and budget definition.
  • C&Q Project Management, Project control, deliverable metrics definition & tracking.
  • Definition and reviewing of C&Q Work Plan, User Requirements, SLIA, CLIA.
  • Technical revision for basic and detail design of the facility, utilities and services.
  • FAT witnessing and coordination of the Isolated Filling Line, Autoclaves, Washers.
  • Clean Utilities Generators.
  • Coordination, supervision, execution and revision of all the commissioning strategies, IQ-OQ-PQ protocol development, execution and review of RABS filling line and Formulation and CIP System skid.
  • Sterilization and Dehydrogenation validation strategy definition, execution and data analysis and assessment.
  • Assessment of the interaction between the construction area whit the adjacent production one. Segregation verification testing.
  • Air Flow Pattern Test analysis in the A and B area.
  • Strategy definition for cleaning validation.