ADVANCED RADIOPHARMACEUTICALS CLEANROOM
Angstrom Technology Develops Advanced Radiopharmaceuticals Cleanroom Suite for Cutting-Edge Theranostics Company, BAMF Health
Radiopharmaceuticals are a group of pharmaceutical medicines that contain radioactive isotopes. Over the years, they’ve commonly been used as diagnostic agents to help doctors detect a variety of medical problems, but recently, they’ve also started to gain recognition as a viable form of treatment for serious diseases like cancer.
Since radiopharmaceuticals contain radioactive ingredients, the cleanrooms in which they’re produced are designed a little differently than traditional pharmaceutical cleanrooms. Additional, often complex, design considerations are needed in order to keep cleanroom operators protected while manufacturing the safest, most effective medicines possible.
This case study examines how Angstrom Technology, a leading expert in cleanroom design, manufacturing, and installation, was able to develop a turnkey cleanroom solution for Michigan State University’s College of Human Medicine and advanced radiopharmaceuticals and theranostics company Bold Advanced Medical Future (BAMF) Health.
Through this project, Angstrom’s work delivered the following:
- A 3,200 square foot, ISO 7 & 8 cleanroom suite with a number of unique features
- A proven high level of expertise in design-heavy cleanroom projects
- A rewarding client relationship that has the potential to result in more cleanroom projects
- A commitment to providing industry-leading health organizations with the resources they need to invent cutting-edge technologies and save lives
About Michigan State University
Michigan State University (MSU) has been working to advance the common good in uncommon ways for 167 years. As one of the top research universities in the world, MSU focuses its vast resources on creating solutions for some of the world’s most pressing challenges. MSU has the top-ranked nuclear physics graduate program and hosts the Facility for Rare Isotope Beams, which is one of the largest nuclear particle accelerators in the world.
One of the pillars of MSU’s strategic plan is to bring health, hope, and healing to those living in the state of Michigan and beyond by focusing on efforts to transform health through innovation.
To do so, MSU formed a public-private partnership (P3) to develop the Grand Rapids Innovation Park, which included the design, construction, and operation of the Doug Meijer Medical Innovation Building. The innovation park provides a platform for all parts of the health ecosystem to come together to solve common problems, capitalize on existing opportunities, create new companies, and innovate at scale.
Through a gift from Doug Meijer and the Meijer Family Foundation, MSU was able to purchase two cyclotrons, 18 hot cells, world-class imaging equipment, and pay for the cost of the buildout of BAMF Health’s radiopharmacy. MSU partnered with BAMF Health to drive the most value from the gift through the development of a lease agreement, as well as an operational agreement for the radiopharmacy space and the equipment within it.
About BAMF Health
BAMF Health is a key innovator in the global radiopharmaceuticals and theranostics industry. With a focus on AI-based precision medicine, molecular imaging, and theranostics, they’re working to create a cutting-edge technology that results in the most efficient, effective, and non-invasive therapeutics for life-threatening conditions like cancer, Alzheimer’s, Parkinson’s, cardiac disease, and more. Currently, they’re the only organization in the United States developing the technology and infrastructure necessary to enable this novel technology to flourish.
BAMF’s flagship facility and headquarters is housed within the Doug Meijer Medical Innovation Building, located in Grand Rapids, Michigan. In addition to housing its world-class radiopharmacy, it also features multiple diagnostic and therapeutic patient care areas. In order for BAMF to manufacture and distribute their radiopharmaceuticals in the safest way possible, the radiopharmacy required a three-part cleanroom suite to be installed — and that’s where Angstrom Technology’s expertise came into play.
Creating & Implementing a Complex Cleanroom Suite Design for an Innovative Health Care Client, Within a New Facility Under Construction
Before this project, the Angstrom team had extensive experience designing, manufacturing, and installing pharmaceutical cleanrooms. So, when we were presented with the rewarding opportunity to build BAMF’s cutting-edge radiopharmacy, we were all-in. Since it would be the only facility in the United States to house this novel, life-saving theranostics technology, we were excited to apply our skills and work collectively with associated teams to get the job done right.
Throughout the project, our design engineers were presented with a number of unique and complex design considerations. First of all, the cleanroom suite needed to contain 17 internal rooms, sectioned into three purposeful areas. Then, various unique features needed to be seamlessly integrated, including hot cells, compressed gas and vacuum, a material movement system, casework, furniture, fume hoods, a robust monitoring system, and more. From a design standpoint, accommodating each of these amenities for optimal process, personnel, and material flow was a heavy lift — one that took over six months to complete.
Once the design was finalized, engineering was coordinated, and permits were issued, installation could begin! The BAMF cleanroom suite was to be housed inside of the Doug Meijer Medical Innovation Building, a seven-story, 212,000 square foot building that resulted from a public-private partnership between Michigan State University and Health Innovation Partners (a joint venture between Rockford Construction, Walsh Construction/Walsh Investors, and Murphy Development Group). But that too came with some challenges.
The first challenge? This building was a new construction. The Angstrom team needed to install a cleanroom within a facility under construction — and we had to maintain clear, consistent communication with our partners at BAMF Health, who was intricately involved in the design of the space, and Walsh Construction in order to do it. On a large job site like this, there are many schedule modifications and safety precautions that can’t be predicted (weather conditions, build site adjustments, etc.), no matter how much we planned for it. We had to work strategically with all the partners, being efficient and accommodating through the duration of the cleanroom installation
The second challenge? Integrating hot cells into the modular cleanroom system, and essentially having them act as one of the cleanroom walls. Hot cells are shielded containment and operating chambers that protect cleanroom personnel from radioactive isotopes within the specialized medicines, and the ones implemented in BAMF’s facility were shipped in from Italy. With laminar air flow, airtight connections, protected dispensing systems, and more, their features make them highly effective tools in radiopharmacies. However, they also make for relatively large pieces of equipment, totaling around 4 feet wide and 12 feet tall, and we needed to accommodate 18 of them into a 3,200 square foot modular cleanroom — all while creating a structurally sound cleanroom, maintaining enough space for efficient workflow, providing access to the hot cells for material movement, and delivering an airtight suite.
A 3,200 Square Foot, ISO 7 & 8 Cleanroom Suite Custom-Designed to Effectively Accommodate Numerous Specialized Amenities
Amidst all the design and installation complexities mentioned, the Angstrom team was able to deliver an amazing finished product! With outstanding efforts from our team of design engineers, we fit all desired amenities within the space, paying close attention to process, personnel, and material flow. And with great communication between our in-house installation crew, general contractors, and various subcontractors, we ensured a smooth installation process within the new construction build.
As a result, the finished product delivered on the following specifications and features:
- A 3,200 square foot cleanroom suite that meets ISO 7 & 8 standards
- 17 internal rooms, sectioned off into three areas: Commercial Operations, Therapeutic Infusion, and Research and Development
- 10-foot internal ceiling height
- Seamless integration of 18 hot cells
- Various types of casework, furniture, and fume hoods
- Environmental control and monitoring systems in each room, all connected to the BMS
A One-of-a-Kind Facility that Offers a Controlled Space for BAMF to Innovate Life-Saving Technologies and Treatments
Angstrom helped BAMF accomplish its goal of designing, manufacturing, and installing a cutting-edge cleanroom suite to safely house various radiopharmaceuticals and theranostics services. The cleanroom suite is now fully functional, allowing BAMF to diagnose patients, treat patients, and manufacture medicines with uniform safety, efficacy, strength, and purity.
Going forward, BAMF will continue to use this flagship facility to create quicker, safer, less-invasive ways to target serious diseases. With their established culture of innovation, BAMF Health is prepared to continue setting the standard of care for the practice of theranostics in West Michigan, and possibly expanding into other states in the future.
As for our team at Angstrom, this project helped us diversify our cleanroom industry portfolio, proudly add to the Medical Mile within our growing home city of Grand Rapids, Michigan, and build the foundation for a strong relationship with BAMF. It was extremely rewarding to be involved in such an innovative, one-of-a-kind project for an important cause, and we’re honored to have been chosen as part of the team that brought it all together.