Meeting the GAP III Program Requirements for a New QC and Research Lab at Bilthoven Biologicals
Recently, I successfully completed a major project in the leading role as senior consultant of Progress at Bilthoven Biologicals (BBio). The focus for my role in the project was on the commissioning and qualification of a new QC and research lab and associated equipment. However, I was involved from the early design phase on, where I had an evaluating role making sure BBio’s requirements were met from the start of the project.
Background
BBio is a company that originated from the Dutch Vaccine Institute, produces polio vaccine for (inter)national immunisation programs. As part of the World Health Organization (WHO) Polio Eradication Program, BBio must meet new standards set by the WHO for working with active polio virus. These requirements are outlined in the Global Action Plan Polio (GAP III and GAP IV) program.
Project overview
In setting up the new lab, BBio enlisted me as their representative for commission and qualification. The design, construction, commissioning and qualification of the lab was outsourced to an external party. My added value was to oversee the commissioning and qualification aspects of the project, taking into account aspects such as user needs, technology, and BBio’s commissioning and qualification standards. I also worked with users to specify the building, utilities and systems, using my expertise to ensure compliance with industry standards and best practices were adhered to. The lab is designed with ample space for all activities, including executive work, utilities, maintenance, aesthetics and safety considerations.
Project team
The project was carried out by a large team, including two BBio qualification engineers, QC and the research department, equipment suppliers and other third parties like me. Technical maintenance personnel and a team of designers were also closely involved.
Project phases
The following five project phases were defined:
- Phase 1: Conceptual design
- Phase 2: Basic design
- Phase 3: Detailed design
- Phase 4: Construction
- Phase 5: Qualification
Phase 1: Conceptual design
The first step in the design process was to establish functional requirements, rather than specifying what the end result should look like. Floor plans and equipment lists were prepared and conceptual designs of major utilities such as HVAC were drawn up. In this phase I was involved in the initial biosafety risk assessment. I drafted the first version of the Validation Project Plan and System impact assessment of the facility and listed equipment.
Phase 2: Basic design
The second phase involved working with an architect to ensure that the design met these requirements. This phase included evaluating the placement of key equipment and determining whether the facility design meets established criteria. My role was evaluative, aimed at assessing whether the proposed design meets the set criteria.
This assessment is particularly important in the qualification process, which involved determining whether the supplier’s proposal was sufficient.
Phase 3: Detailed design
Phase 3 follows the same evaluative approach as Phase 2, but operates at a different level of detail. Equipment and equipment suppliers were selected and detailed documentation was prepared, evaluated and approved for construction. In this phase we used Requirement Traceability Matrices for the evaluation of the detailed design. I updated the VPP to match the final design and conducted assessments for family and matrix approaches for certain qualification activities.
Phase 4: Construction
In phase 4, the focus shifted to the implementation of commission and qualification plans. Plans were reviewed to ensure they were in accordance with established specifications and anything that required qualification was addressed appropriately. I was responsible for this review process within BBio and ultimately approved the final commissioning and qualification protocols.
Phase 5: Qualification
Phase 5 involved execution and qualification, which was mainly carried out by contractors. My role was to attend and support the commissioning and qualification activities and to ensure that the results were reported according to BBio standards. As part of these reports, I have completed and approved Traceability Matrices, which trace user requirements back to design, commissioning and qualification testing.
Challenges
The main technical challenge was ensuring that the lab is completely contained, with negative pressure and multiple airlocks to prevent pathogens from escaping. While this can be difficult to accomplish in an operational lab, it is necessary to ensure the safety and security of those working in the facility and the safety of the lab’s external environment. However, the prospect of meeting the new standard is exciting and a testament to the continued commitment to advancing biocontainment .
My biggest challenge was keeping all parties aligned with their different perspectives on the common goal. Although everyone had the same end goal, the way to get there varied from person to person.
Result
Although there were some bumps in the road, I found the whole process of the project very diverse. I am grateful to be involved from the start in November 2018 as the project lasted about four years. I always kept the end goal in mind and was curious about the end result. The project was executed effectively and efficiently on time and under difficult conditions. BBio is very satisfied with a completely newly equipped and qualified up-to-date QC and research lab.
