by Kevin Chronley
Nitto Avecia is a premier research and contract manufacturer in the innovative oligonucleotide market. They developed a strategy to build a new 2-story, approximately 100,000sf cGMP manufacturing facility with a bulk solvent tank farm and space for office, lab, and cGMP manufacturing operations.
The project’s design and the need to procure long-lead innovative process skid systems unfolded in the summer of 2021, therefore driving the procurement, construction, and CQV to unfold during the peak of the supply chain crisis. Delivery of the finished facility was scheduled and achieved for May 2023. To achieve schedule and budget objectives, throughout the project execution A/Z developed and implemented creative and alternative strategies to mitigate impacts, including:
- Contract Strategy – Although a design-bid-build contract strategy had been implemented, A/Z promoted a collaborative and coordinated environment typically associated with Integrated Project Delivery, engaging the subcontractors in design-assist roles.
- Building Information Modeling (BIM) – BIM proved to be exceptionally valuable by simplifying the change dynamics and integration challenges of the phased approach, enabling numerous workarounds, and sorting out both supply chain alternatives and labor availability.
- Team Building – Nitto Avecia and A/Z enjoyed an extraordinary level of team-building and safety behavior incentives, such as monthly food truck events, hockey games, and award raffles, enhancing interaction and shared culture.
Although the extremes of the COVID supply chain crisis have passed, how A/Z overcame those supply chain challenges is as relevant as ever. The underlying financial objectives behind most capital improvement projects benefit from creative alternatives and workarounds; A/Z implemented several to support the project:
- Electrical Switchgear – A major challenge was last-minute extended delivery dates ranging from 6-12 months. Working collaboratively with Brattan Electric, A/Z installed a temporary 2,400kW system to facilitate a phased CQV.
- Phased CQV – The challenge was to selectively schedule and phase CQV, starting with UPS water, chilled water, and HVAC. Our strategy included safety coordination, team member development, and site controls to provide the CQV personnel with safe egress, isolation, and containment. These efforts ensured that utilities were made safe for CQV testing and inspections while construction continued. In addition, we implemented a preliminary phase of Site Acceptance Testing (SAT) technique whereby off-site SAT was used to facilitate preliminary IQ/OQ testing and inspection on defined systems and skids. This investment in preliminary testing bolstered operational confidence, resulting in a compressed commissioning and CQV phase.
- Prefabrication – Hart Design & Engineering assumed a design-assist role, providing procedures and workarounds even though the dynamic phasing didn’t allow for process design until the core and shell were well underway.
Ultimately, the project met the client’s budget, schedule, and CQV requirements and involved countless acts of collaboration, diligent technical expertise, and cGMP compliance. Some examples are highlighted within; however, the obvious lessons learned are that the success of a project is due to team members understanding their roles, active and focused participation, and relentless team support throughout the project’s execution.
Kevin Chronley
Kevin Chronley is president of A/Z Corporation.
