FLEXIBILITY THROUGH AUTOMATION
Perhaps the most significant element of the plant's design is the high degree of automation, an approach driven by the need
for operational flexibility, and allowing for easy changeover on a batch-by-batch basis. The complex and sophisticated process
for identifying appropriate automation elements addressed the following:
- Distributed control system (DCS) software was developed with flexibility in mind—in small operating blocks associated with
unit operations rather than large recipes that would control the complete process.
- The programmable logic controller (PLC) associated with specific vendor skids were an important part of the automation solution.
- Definition of a user requirement specification (URS) before the software bid process, enabling a more tailored approach in
matching requirements with software solutions.
- An overall philosophy of seeking out value-added automation when selecting what and how to automate key functions.
- Use of the global automation solutions core modules from the Pfizer Global Manufacturing IT software library. These standard
units of automation code can be drawn down and used by any site, minimizing software development and testing efforts.
- A multistep approach in separating the functional and detailed design specification documents into a functional specification
and a detailed design specification (DDS). This enabled the process subject matter experts to develop process requirements
upfront; it also allowed the automation resources to ensure the functional requirements are met in the DDS and relayed on
to the software.
- Conducting a thorough Pfizer quality audit of the automation integrator quality systems, enabling use of their quality system
and resources. This means that the team can use supplier test methods and documentation without the need to develop project-specific
- Planning ahead for postproject system support by tapping a nearby Pfizer Ireland Pharmaceuticals Operations support group
for colleagues that could be assigned to key project positions and developed for ongoing support. (This group is a central
automation and information technology function that supports all Pfizer manufacturing sites in Ireland.)
BEST TEAM, BEST PRACTICES
The Shanbally project is a complex coordination of interdependent considerations that must balance a variety of inputs: strategic
considerations for Pfizer's biologics infrastructure; operational requirements needed for future clinical-scale production
work; and logistical elements that center on time, space, and budgetary constraints. To meet the challenge, Pfizer assembled
an approach based on best practices in facility planning, cross-functional team input, and company-wide initiatives in design
and operational excellence.
From the start, the new facility drew on multiple disciplines. The design and build process required global input from a project
team of individuals with specialized backgrounds. The project leverages the know-how of specialists in technical services
and production, quality and regulatory issues, laboratory operations, and engineering. Various subject matter experts from
corporate support groups and operating plants in the Pfizer network are also involved to provide input on key design disciplines
ranging from quality control laboratory size and design, to the specifics of downstream processing platform technology.
This core team of 10 people will work through design construction, commissioning, and qualification, and will stay through
the whole process, right up to the point where the plant is making its first batches. At every step, Pfizer needed the involvement
of people who understood the project processes and what is required to deliver an operating plant. Rounding out the project
team are seven key stakeholders, representing Pfizer Global Manufacturing, Pfizer Global Research & Development, Quality functions,
and appropriate Pfizer manufacturing plants.
Because the Shanbally plant will form a key component in the company's global biologics infrastructure, the design and build
process had to address a number of important Pfizer-wide operational excellence initiatives.
Among these is Right First Time (RFT), the company's program for encouraging colleagues to apply Six Sigma and other tools
to the task of understanding and improving key processes—with the goal of reducing process variations, making them stable,
and allowing for future optimization.
Together, RFT and Lean manufacturing were used for assessing the facility layout. For example, the laboratory area was evaluated
in depth to ensure its layout supported the test cell philosophy for efficiently carrying out future activities, requiring
optimization that affected availability of utilities, sinks, storage space, and instrument location. Process equipment was
designed with the use of process analytical technology (PAT) systems in mind.
Quality risk management tools were used to assess the facility design with regard to European Union (EU) and US regulatory
requirements. The team worked to ensure the plant design complies with requirements of the EU Annex 2 Guidance on Manufacture
of Biological Medicinal Products for Human Use and with all relevant FDA requirements. Shanbally also will meet the requirements
of the Irish Medicines Board. The project team concentrated on reviewing the 3D model to ensure it met the quality expectations
for the overall design.