Location: Billerica, Massachusetts, USA
Aseptic Fill-Finish Facility
Pharmalucence, a Sun Pharma Company receives honorable mention for their execution and the entrepreneurial spirit demonstrated by the construction of their new aseptic filling facility in Billerica, Massachusetts.
Pharmalucence aseptically fills and finishes a portfolio of legacy and generic radio-pharmaceutical products, many of which are in market shortage. Their existing operations, housed in four separate rental facilities, were in critical need of modernization to address operational inefficiencies and dated facilities. They recognized that a significant change was needed to ensure the long term availability of their product supply and the viability of their business. Given limited financial resources their challenge was to effectively plan, prioritize and implement the upgrades needed for full regulatory compliance and product supply integrity all within a competitive business model.
Pharmalucence partnered with a full service engineering company, to develop a strategic business model and execution plan. Weighing options, they took the bold financial and technical step to consolidate their four existing operations into a single modern facility. They identified an existing facility large enough for their objectives and near enough to retain existing staff. Utilizing QbD principles they started the facility design with the project deliverables well defined in order to minimize costly delays and changes. RABS and isolators were fully compared and for their particular aseptic processing needs isolators proved the most cost effective solution.
Their project implementation plan took into account their existing lease obligations, product supply obligations and construction timelines. New areas were prepared and equipment transferred to correspond with the expiration of leases for economic efficiency. The completed facility is fitted with high quality finishes and an installed equipment base consistent with industry best practices. Their uses of risked based CQV help ensure a quick and effective operational start up.