Combination Product Inspection Facility – Automated, Semi-Automated and Manual Inspection
A large Midwestern pharmaceutical company planned to build a new facility dedicated to inspection of finished cartridges and syringes for use in an injection pen (a combination product). This facility would centralize inspection processes and also provide new automated inspection capabilities in addition to semi-automated and manual inspection. This project was critical to eliminate an inspection bottleneck prior to device assembly and was critical to meet increasing product demand.
Performance Validation (PV) was selected for this project because of their strong performance on previous projects at this site as well as their prior experience with device assembly equipment. PV worked as an integral part of the project team throughout the project providing input at design meetings, supporting building construction and commissioning, and qualifying the inspection equipment. Performance Validation support included:
- Attendance at Factory Acceptance Testing (FATs) to ensure equipment met specifications prior to shipment and performed on-site testing to ensure machine performance. Following FATs, PV managed the issues punchlist to ensure all items were resolved in a timely and acceptable manner.
- Collaboration with the equipment design engineers, equipment owners and automation engineers to ensure complete and accurate testing was developed for each inspection line and station. PV supported execution and issue resolutions throughout all commissioning and qualification activities.
- Working closely with the client project manager to develop, maintain, and update the challenging timeline for project delivery. This included driving pre-approval, execution and closeout of hundreds of test cases over a 6 month period.
- To reduce the project timeline and cost, PV leveraged prior testing for similar semi-automated and manual inspection equipment to minimize document document development efforts.
The project delivered the inspection systems on time without compromising quality or performance. On final approval of the project deliverables, the new inspection systems were placed in service to inspect the backlog inventory of product.
The new inspection system eliminated the inventory backlog of components that provided an immediate increase in product output. Ongoing use of the inspection system has consistently met production expectations with respect to quantity of syringes/cartridges inspected and false reject rates for the first six months of use.
For additional information, contact:
Vice President & Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241