Aseptic Fill/Finish Facility EPCMV
To meet the short- and long-term business objectives, IPS was commissioned by Pharmalucence to help consolidate the generic and contract manufacturing operations in 4 buildings into a single, state-of-the-art manufacturing facility to meet FDA and EU requirements. The new facility consists of aseptic core, inspection and secondary packaging, along with an increased capacity and capability for biologics.
This project received an honorable 2015 Facility of the Year Award (FOYA) recognition. The Judging Panel said “Pharmalucence is honored for accepting risk and succeeding in building a new facility that effectively addressed the market shortage for low margin legacy and generic radio pharmaceutical products. Through good planning and prioritization they met the challenge of balancing investment, appropriate compliance, efficient operations and business viability.”
IPS provided strategic master planning, site selection/utilization review, conceptual / detailed design, equipment selection/URS, and EPCMV services.
The facility supports increased capacity and capability to meet ongoing demand for current products. It provides the foundation for new product line additions and ensures the company is a key source for contract production of injectible drugs. IPS implemented lean project integration techniques to include all shareholders early in the project to target cost in order to meet client financial requirements. A risked based CQV approach was adopted for equipment and facility qualification, process validation, analytical method validation and cleaning validation and it resulted in a lean process along with reduced validation costs which was required by the project’s budget.
State-of-the-Art, cGMP Aseptic Fill/Finish Facility with very aggressive timeline
Driven by Lean Integration, Target Costing and $GMP delivery methods
Isolator vs. RABs Analysis
Taking advantage of stimulus funding, a phased approach was undertaken to invest in production infrastructure
Strategic procurement strategy and lean project delivery methodology resulted in significantly lower cost per square foot metrics