Facility of the Year Award
Congratulations to Eli Lilly and Company for receiving the Facility of the Year Award from the International Society of Pharmaceutical Engineering (ISPE) in the category of Facility of the Future.
As described by ISPE “When considering an entry worthy of the Facility of the future award, the judges were looking for the application of technology and project delivery to create a step change in our industry’s operating model. Lilly’s process development, production platform commitment and deployment of three replicate operational continuous Oral Solid Dosage production facilities is a worthy winner.”
At the Indiana facility, Performance Validation (PV) provided validation engineering resources to aid in the development and execution of the testing for this equipment, and to provide a lifecycle approach for documentation, including requirements, specifications, system and component criticality assessments, and summaries using the company policies and procedures, to successfully release the equipment. Activities included:
- User Requirements and Design Specifications: collaborated with internal process engineering prior to testing to establish critical process parameter ranges and critical user requirements to achieve optimal performance of the equipment.
- Failure Modes and Effects Analysis (FEMA): Facilitated FMEA meetings for Process train equipment. Meetings included client subject matter experts from areas such as Process Engineering and Automation.
- Equipment Acceptance: interfaced with the vendor to complete factory turnover of the computer communication system software package prior site acceptance.
- Commissioning: developed, executed and compiled Commissioning Packages, which contained Receipt Verification, System Installation Verification, and Functional Testing.
- Qualification: developed and executed the qualification testing for critical process parameter ranges successfully through release for GMP use.
- Leveraged protocols that were utilized to qualify development equipment to streamline the document develop process and provide cost savings for the customer.
- Project Management: provided active leadership and communication throughout the duration of the project, helping the project team to identify and avoid potential bottlenecks.
Again congratulations to Eli Lilly and Company and all the supporting contractors who assisted in delivery of the project.