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Projects

Aseptic Fill-Finish Facility

Pharmalucence, Inc., Billerica, MA

Consolidated generic and contract manufacturing operations in four buildings into a facility consisting of aseptic core, inspection and secondary packaging, with increased capacity and capability for biologics.

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.

Client Name: Pharmalucence, Inc.
Region: AmericasCountry: United StatesOffice: Blue Bell, PA
Services: Engineering, Construction Management, Procurement, Commissioning, Qualification & Validation, Facility Master PlanningIndustries: Pharmaceutical, Aseptic
Size: 70,000sfAwards: 2015 ISPE Facility of the Year Award, Honorable Mention
Client Name: Pharmalucence, Inc.
Region: AmericasCountry: United StatesOffice: Blue Bell, PA
Services: Engineering, Construction Management, Procurement, Commissioning, Qualification & Validation, Facility Master PlanningIndustries: Pharmaceutical, Aseptic
Size: 70,000sfAwards: 2015 ISPE Facility of the Year Award, Honorable Mention

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