Life sciences manufacturing facilities integrate mission-critical process equipment that demands significant financial investment, detailed space programming and utility requirements design coordination, long lead times, and meticulous construction sequencing plans from all project stakeholders. Given these demands, each project requires unique strategies to ensure that process equipment is properly integrated into all aspects of the project from early concept through Commissioning, Qualification, and Validation (CQV). In this blog, we’ll explore several process equipment management strategies to build these facilities successfully.
Procurement Timing and Design Integration
The coordination of process equipment, as well as utility and spatial requirements within a life sciences facility, significantly impacts the design process. These requirements can take a year or longer to be fully defined after the issuance of the equipment order. Projects that proceed too far down the design development process without a clear understanding of the process equipment needs may incur changes that impact project success. To ensure the proper integration and coordination of the facility and process design, it is important to procure the process equipment as soon as the project is kicked off, ideally before the design process is underway. Depending on the owner’s contracting strategy, the process equipment is typically either directly procured and furnished by the owner or procured directly by the contractor with engagement/input in the procurement process from the owner and process engineering consultant. Either strategy can be implemented with positive results, but this must happen early in the project development process to enable the follow-on phases to be successful.
Sequencing, Logistics, and Schedule Integration
Process equipment for life sciences projects is typically larger, heavier, and more complex than facility equipment found in other sectors of the commercial construction industry. Once the basic parameters associated with the equipment are known, such as physical dimensions and weight, the project team should take an integrated approach to incorporating this equipment into the planning process. Some key questions include:
- Will there be any requirements for oversize or wide load permits? If so, what routes can handle this load from the port of entry to the job site?
- What 3D path will the equipment need to travel from the point of receipt on-site and inside the building (that is under construction) to get to its final destination?
- Given the size of the equipment or assumed shipping splits (if skidded), what are the roof, exterior and interior walls, or floor slab leave-outs required to achieve the path?
- What means and methods will be used to rig the equipment into place?
- Is the permanent building structure suitable for the temporary loading of the equipment along the rigging path per the proposed rigging methods? If not, what is the temporary shoring strategy, and how may that affect other trades’ work?
- What ‘no-fly’ zones are required until the equipment has been rigged into place?
- How will the selected path and its required leave-outs and no-fly zones affect other trades’ work, such as overhead MEP services and, potentially, startup activities, depending on project and equipment phasing?
Ultimately, the answers and the defined plan that results will improve the reliability of the site logistics, project phasing, and sequencing of other trades work. Multiple solutions to the questions above may exist, each with its benefits and drawbacks, and the team can quickly weigh the options with a lean decision tool, such as an A3 Lean thinking form or a Choosing by Advantage (CBA) matrix, with input from all impacted stakeholders on agreed-upon criteria. Additionally, early engagement from a rigging contractor to integrate their rigging plans can be a successful strategy to prevent negative impacts on cost, schedule, and safety risks.
Procurement Management Strategies for Process Equipment
Regardless of the entity holding the purchase order(s) for the process equipment, it is critical that the project team has transparent insight into the agreement and the design, procurement, fabrication, assembly, factory acceptance testing (FAT), site acceptance testing (SAT), and turnover package milestones contained therein. Unique payment requirements may also need to be accounted for in an appropriate cash flow projection.
Our recommended best practice is to integrate the full vendor schedules within one project-integrated, cloud-based P6 schedule, including deliverables owed by the project team to the vendor, so that all appropriate relationships within the schedule can be linked accordingly. This empowers the scheduling and operations teams to assess and escalate process equipment activities that may drive the project’s critical path and allow for proactive mitigation activities. This data should typically be updated biweekly with input from the vendors.
Depending on the project’s complexity, contract, and process equipment, the project team and/or owner may decide to include delay damage clauses within the purchase orders. These terms can serve as “teeth” to hold the vendor accountable for the schedule objectives. Typically, these damages will not be sufficient to offset the losses that an owner may incur due to schedule delays or quality issues with the process equipment. Rather than relying solely on these contract terms to influence the outcome, regular shop visits should be incorporated to build confidence and mitigate risk to the project, including third-party periodic or regular presence as an additional measure where necessary.
Site Rigging and Final Connections
Depending on particular equipment and its application, there may be site installation tolerance criteria of only a few millimeters for a final setting-in-place. One example is lyophilization chambers, which can weigh 60 tons or more and require an exacting tolerance. Therefore, it is critical to understand the vendor expectations for tolerance as early in the project as possible. This enables the team to set up the site, planning, and procurement with appropriate control, rigging strategies, and field confirmation after placement, including sign-off by the vendor before the final set and/or bolting down of the equipment. Equipment protection is also critical due to the work that typically occurs around it after being set.
Equipment Start-Up and Turnover
Numerous inspection and verification processes need to be implemented and accounted for concerning process equipment. Process equipment is subjected to FAT at the fabrication facility to confirm performance in alignment with project specifications. Once the equipment is delivered to the project, all upstream utilities are connected and commissioned, and the process equipment undergoes SAT to demonstrate compliance. Another complexity is the equipment must be provided with a highly detailed Vendor Turnover Package (VTOP) to document all components, products, and aspects of the equipment. The VTOP structure must be developed early in the project as this deliverable must be validated as complete before commencing CQV activities.
Construction is not complete without start-up first. Once walk-downs have verified that equipment installation is complete, then equipment can be energized. Vendor representation must be scheduled well in advance for the timely start-up of equipment. Team alignment on system boundaries and turnover documentation is essential for the timely turnover to CQV activities and subsequent operational readiness.
In summary, the unique characteristics and requirements of process equipment on life sciences projects present numerous challenges throughout the project lifecycle. If managed proactively and collaboratively, the project team can incorporate strategies that improve the project’s reliability in all aspects.
