Insulin Project III
Client: Eli Lilly
Location: Florence, Italy
Scope: Pharmaceutical, Fill-Finish Facility
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.
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.