Medical Manufacturing Facility Design Challenges

Building a modern medical manufacturing facility presents engineering and construction challenges due to the complex systems and equipment involved.

Complex MEP (Mechanical, Electrical, Plumbing) Needs

One of the biggest challenges was designing a space large enough to house a complex MEP system. In addition to standard HVAC equipment, lighting, electrical, and plumbing, the customer needed to incorporate specialty exhaust and ductwork systems, and intricate chemical delivery and waste systems.

Cleanroom Production Space & Hazardous Substance Storage

Boston Scientific required a cleanroom production space with a gowning area. Cleanroom design is complex because of the stringent guidelines surrounding temperature control, humidity control, airflow, and air particle count. Medical device manufacturing often uses gases, deionized water, and chemicals for production, each of which has specific system requirements. They also required dust collection, an essential component to capture particles generated by their specialty manufacturing process. Additionally, all systems for cleanroom function are housed elsewhere in the building and needed to be run to the production space.

Contamination Prevention & Disruption Avoidance

Cleanroom production spaces have stringent operating guidelines that impact procedures for any repair and maintenance on infrastructure. The FDA also enforces Current Good Manufacturing Practices (cGMP) to ensure adherence to regulations surrounding the design, monitoring, and control of manufacturing processes and facilities. The customer operates their Maple Grove campus 24/7 with three shifts daily. Disrupting medical device production for tasks as simple as lighting or filter changes would be costly due to production downtime.

The Solution

Building Information Modeling (BIM) was a critical tool in designing the complex MEP layout and creating spaces for all mechanical, electrical, and specialty services. Creating a multi-layer MEP design model took several months due to the complexity of the system and continual iterations of production layout. Mortenson, trade partners, and the design team paid special attention through the BIM process to allocate future expansion needs.

In addition to ensuring proper spacing for field installation, BIM allowed for:

• Prefabrication to aid an already tight schedule
• Certainty of outcome knowing all pieces would work together before arriving in the field
• Cost certainty due to reduced re-work resulting from inaccurate field measurements or unanticipated conflicts with other trades.

The design solution for providing a flexible space for MEP infrastructure and reducing maintenance impacts to production was a walkable cleanroom suspended ceiling. Fully containing MEP above the production space allows facilities staff to inspect and maintain equipment without entering the production area. The walkable ceiling is also easily re-configurable to meet the customer’s current and future needs for flexibility.

Unanticipated Challenge: Supply Chain Disruption

Due to global procurement challenges, the team had an opportunity to provide creative solutions to keep the project on schedule.

Material Procurement

Steel decking is one of many materials affected by shortages and long lead times. When the customer decided to handle ordering the steel decking themselves, they chose a European supplier. With the product shipping from overseas, the project team had to be diligent in tracking production and shipping, as transportation delays could disrupt their project sequence.

The material itself also presented challenges. In partnership with the design team, customer, and city inspectors, Mortenson led the comparison study efforts between the specified American product and European product to ensure that material tolerance, testing requirements, and structural integrity were comparable and acceptable for project use. With all parties collaborating, verifications that could have taken several months were assessed and approved with no major project delays.

Delayed Orders

When two 20’ tanks ordered by the customer were delayed in fabrication, the team had to respond quickly. The tanks needed to be installed before the storage area’s exterior walls. Construction delays were not an option due to the tight schedule, so the team built a temporary wall that could be broken down easily and rebuilt after the tanks arrived. Paying extremely close attention to procurement schedules proved critical in mitigating missed deadlines. Mortenson’s team remained in constant communication with suppliers to identify long lead time items several months in advance, providing sufficient time to switch suppliers and research alternative materials as needed.

Project Results

Mortenson kept the project on schedule despite multiple challenges and design iterations to meet the customers evolving needs. As a result, we delivered the project on time, and the customer remained on schedule with the internal processes required to prepare the space for production.