Pharmalucence.ProductionPharmalucence is ISPE’s 2015 Facility of the Year Award Category Winner Honorable Mention 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.

Accomplishments

  •  The Pharmalucence Business and Facility Integration Project provides a business case to solve the legacy facility, legacy product, drug shortage problem: This project will have a major impact on the pharmaceutical industry by providing an economically viable approach to delivering cost sensitive drugs by manufacturing in a state-of- the-art facility utilizing cutting edge processes while meeting internationally harmonized regulatory compliance expectations. This project team was able to define and implement this low cost, compliant and reliable supply model solution for drug shortage prevention while the rest of the industry was just defining the root cause and prevention program.
  • The first project to use an innovative integrated facility ICH QRM design approach to QbD: This project utilized risk based analysis for all key design decisions from the point of inception. Facility integration based design decisions for technology and facility layout were all evaluated and documented against business, operational, technological and financial risk throughout the entire design process eliminating design changes and forming the basis for an integrated CQV process. This project design process is likely the first practical model of the QbD design process alluded to in the ICH Q8, 9, and 10 documents.
  • Synergistically merged facility and process technologies to meet the regulatory requirements for integration, separation and automation:  This project has utilized a fully integrated filling line that incorporates isolation technology, single-use product contact parts, automated lyophilizer loading and unloading, and 100% check-weighing. The design integrates the facility with the equipment with a modular panel system that allowed for accelerated installation, walkable ceiling to access the integrated isolator and the flexibility for the addition of a second future lyophilizer without disruption to the new lines’ production schedule.
  • Developed and implemented a new superior conceptual planning process based on predefined operating philosophies and processes: This project utilized a cutting edge design process that is based on an ICH Q9 risk based approach. The process defines and documents, in order, the business mission; project mission; business, operational and engineering objectives; all operational philosophies; products and product parameters; the manufacturing processes and then the traditional engineering design process begins. This process ensures you begin with the end in mind and results in fewer design changes and a significantly shorter design process.
  • Utilized a fully integrated, GMP based turnkey project delivery approach that prioritized schedule, outsourced capital risk and secured regulatory compliance: An integrated design-build-validate package was awarded to IPS. The lean, integrated approach allowed for an accelerated schedule that was required to meet rapidly ending leases. The $GMP contract limited Pharmalucence’s budget risk, and the design firm’s portfolio of regulatory approved barrier technology driven designs ensured minimal compliance risk.

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