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:
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