Used to diagnose and treat life-threatening diseases, radiopharmaceuticals make up a relatively new sector in the field of medicine. And, due to their radioactive nature, they need to be managed and manufactured a bit differently than traditional pharmaceuticals. This is why it’s critical (and required by public health standards and laws) that radiopharmaceutical drug production is done in a highly controlled cleanroom that’s equipped to store, prepare, fill, and pack radioactive materials safely. 

Below, we’ve created a guide to radiopharmaceutical cleanroom design — giving you an inside look at all the design considerations that go into creating one of these controlled, cutting-edge spaces. 

6 Key Radiopharmaceutical Cleanroom Design Components

Of course, all radiopharmaceutical cleanroom designs are a bit different. It depends on a variety of factors, such as the particular application happening within them, the space in which they’re built, etc. However, many of them have the same basic components and design considerations. We’ve listed six fairly common ones below:

1. Radiopharmaceutical Cleanroom Classification

The main component of any cleanroom is its ISO classification, and radiopharmaceutical cleanrooms are no different. In most cases, radiopharmaceutical cleanrooms are required to meet ISO Class 7-8 standards. However, they may also have designated areas or chambers that must meet even more stringent standards, like ISO Class 6 or higher. 

2. Radiopharmaceutical Cleanroom Type

In order to meet high levels of cleanliness and environmental control, radiopharmaceutical cleanrooms are most often built as HardWall structures. This type of cleanroom has the most control over contamination, temperature, humidity, pressure, and static. 

3. Radiopharmaceutical Cleanroom Size

Cleanroom size can greatly vary from one radiopharmaceutical cleanroom project to another. But in terms of effective radiopharmaceutical cleanroom design, the most important thing to consider is allowing enough space for all necessary equipment, as well as personnel and product flow. 

Radiopharmaceutical cleanrooms generally host multiple pieces of equipment, the most common being hot cells. Hot cells are shielded containment and operating chambers that protect cleanroom personnel from radioactive substances within the medicines. 

They’re usually around 4 feet wide and 12 feet tall, so allocating space for a few of them can be challenging — especially when you also need to accommodate space for efficient workflow surrounding them. That’s where a radiopharmaceutical cleanroom designer’s expertise really comes in handy. 

4. Radiopharmaceutical Cleanroom Pressure

Radiopharmaceutical cleanroom design can also get a bit complicated when it comes to pressurization and confirming there is a cascading effect; where the most stringent or highest classification cleanroom should have the highest positive pressure. When a facility has multiple cleanroom areas (which is typical in radiopharmaceutical applications), it’s critical to design pressure and air to flow a certain way so that particles and contaminants are unable to enter the most controlled space in the facility. 

In addition, radiopharmaceutical cleanrooms typically have fume hoods that are operating at ISO 5 and need to be exhausted to the exterior or out of the cleanroom suite.

5. Radiopharmaceutical Cleanroom Temperature & Humidity

In radiopharmaceutical cleanrooms, temperature and humidity are both important factors to keep under strict control and monitoring. Radiopharmaceuticals cannot be kept under extreme temperatures or humidity levels, otherwise they will become less effective, run the risk of microbial growth, or be unsafe for human consumption. Therefore, environmental control and monitoring systems are built into many radiopharmaceutical cleanrooms’ designs. 

6. Additional Equipment & Technologies for Radiopharmaceutical Cleanrooms

Finally, radiopharmaceutical cleanroom operations call for a variety of unique pieces of equipment and technology. These devices could include (but aren’t limited to) some of the following:

  • Hot cells
  • Isolators
  • Elaborate casework
  • Fume hoods
  • Environmental control and monitoring systems (which can be connected to the building management system, or BMS)
  • Biosafety cabinets
  • Sterile work tables and surfaces
  • Cyclotron storage
  • Gowning rooms

Hoping to design and install a radiopharmaceutical cleanroom in your facility? Let us know! At Angstrom Technology, our team can help you build a modular cleanroom that’s perfect for your project needs. To get started working with us, contact us online

Interested in learning more about one of our latest radiopharmaceutical cleanroom projects at Angstrom? Check out our Advanced Radiopharmaceuticals Cleanroom Project page or our recent case study.