Radiopharmaceutical Cleanroom FAQs
Interested in learning about the radiopharmaceutical industry and radiopharmaceutical cleanrooms? As an experienced radiopharmaceutical cleanroom manufacturer, we’re here to answer any questions you have about the design or installation of these innovative spaces.
To get you started, we’ve listed 10 of our most frequently asked questions about radiopharmaceutical cleanrooms, along with their answers, below.
1. What Are Radiopharmaceuticals?
Radiopharmaceuticals are a group of pharmaceutical drugs that contain radioactive isotopes. In the past, they’ve mainly been used as diagnostic agents that help doctors identify a number of medical problems.
However, they’ve recently gained recognition for being viable forms of treatment for life-threatening conditions like cancer. For those cases, the radiopharmaceutical drug is absorbed into the cancerous area, then destroys any affected tissue. Many patients have found radiopharmaceuticals to be a less-invasive, less-painful alternative to other chemotherapy and radiation techniques.
2. What Risks Are Associated With Handling Radiopharmaceuticals?
In traditional pharmaceutical applications, the main goal is to protect sensitive products from being harmed by contaminants. However, in radiopharmaceutical applications, there are two goals: to protect the products and to protect the people handling them.
Why? Radiopharmaceuticals contain radioactive isotopes, which can be harmful to human health after lengthy or frequent exposures. Too much radiation exposure has been known to cause the following health conditions: skin burns, acute radiation syndrome, cancer, cardiovascular disease, reproductive issues, and more.
3. What Is a Radiopharmaceutical Cleanroom?
As the name suggests, a radiopharmaceutical cleanroom is a controlled cleanroom environment in which radiopharmaceuticals are tested, produced, packaged, or distributed. Radiopharmaceutical cleanrooms are not the same as traditional pharmaceutical cleanrooms, as they have unique control, cleanliness, and process requirements in order to ensure patient and operator safety. They also house different types of cleanroom furniture and equipment.
All this said, it’s important to be aware of any unique design considerations radiopharmaceutical cleanrooms require.
4. What ISO Classification Do Radiopharmaceutical Cleanrooms Require?
In most cases, radiopharmaceutical cleanrooms are required to meet ISO Class 7-8 standards. However, they may also feature some designated areas or chambers that meet even more stringent standards, such as ISO Class 6 or above.
5. What Other Quality Standards Do Radiopharmaceutical Cleanrooms Need to Meet?
ISO standards aren’t the only quality standards that radiopharmaceutical cleanrooms need to meet. In most cases, they also need to meet GMP standards and USP standards.
GMP stands for Good Manufacturing Practice, which is a quality management system enforced by the US Food and Drug Administration and used mainly by medical and pharmaceutical manufacturers. The main goal of these standards is to minimize the risks of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices.
USP stands for United States Pharmacopeia, which is “an independent, scientific nonprofit organization focused on building trust in the safe supply of safe, quality medicines.” USP is not a government entity, but works alongside government agencies and regulatory authorities around the world to safeguard the global supply of medicines and other consumable products. Their standards are legally recognized in the United States and are used in over 140 countries.
The main goals of these standards are to protect patient and worker safety while developing, packaging, distributing, and consuming medicines and dietary supplements. The USP standard that’s most pertinent to radiopharmaceutical applications is USP 825, which you can read more about in our previous blog post.
6. What Types of Equipment Do Radiopharmaceutical Cleanrooms Require?
Radiopharmaceutical cleanrooms require various types of equipment, some of which are completely different from those found in traditional pharmaceutical cleanrooms. A few common types of radiopharmaceutical equipment include:
- Hot cells
- 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
7. What Type of Cleanroom Is Best for Radiopharmaceutical Applications?
Radiopharmaceutical cleanrooms require a high level of environmental control in order for drugs to be safe and effective for patient use. Therefore, HardWall cleanrooms are generally the best option, as they can accommodate that high level of control against contamination, temperature, humidity, and more.
8. How Big Do Radiopharmaceutical Cleanrooms Need to Be?
Your radiopharmaceutical cleanroom can be any size your facility needs. However, when determining cleanroom size, it’s important to consider all the specialized furniture and equipment it needs to house. Things like hot cells and isolators aren’t small, so make sure your cleanroom can accommodate the amount that you need.
Another important consideration is that with modular cleanroom design, you always have room and opportunity for growth. If your facility chooses to expand in the future, modular design allows for quick and simple reconfigurations and additions — but that process is only quick and simple if it’s planned for ahead of time.
For almost all cleanroom projects, we recommend that facilities plan for this growth during the initial design phase. Considering what expansion will look like or could potentially be is an important step in eliminating additional costs or unwanted downtime within the cleanroom.
9. What Type of Pressure Do Radiopharmaceutical Cleanrooms Require?
More often than not, radiopharmaceutical cleanrooms are actually radiopharmaceutical cleanroom suites, which contain multiple different controlled rooms or zones. Within these cleanroom suites, cascading pressure is typically required.
Cascading pressure means the most stringent cleanroom zone has the highest level of pressure, and the least stringent cleanroom zone has the lowest level of pressure. This helps ensure that contamination and particles will not flow into the most critical or cleanest zone.
10. What Radiopharmaceutical Cleanroom Projects Has Angstrom Technology Completed?
In October 2021, Angstrom Technology completed a radiopharmaceutical cleanroom suite project for Michigan State University’s College of Human Medicine and Bold Advanced Medical Future (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.
The cleanroom facility is based in Grand Rapids, MI, and totals 3,200 square feet. Here are some of the details:
- 17 internal rooms, sectioned into three main areas: Commercial Operations, Therapeutic Infusion, and Research and Development
- HardWall cleanroom
- ISO 7 & 8
- 10’ internal ceiling height
- Environmental control and monitoring systems in each room, all connected to the BMS
- 18 hot cells
To learn more about this project, visit our Advanced Radiopharmaceuticals Cleanroom page.
Design & Build Your Radiopharmaceutical Cleanroom With the Experts at Angstrom Technology
With the recent development of advanced radiopharmaceutical treatments and therapies, radiopharmaceutical cleanrooms are on the rise. If you’re hoping to build one of your own, contact our team at Angstrom Technology. We can help answer your questions, guide you through the process, and install a cleanroom that meets your facility’s specifications.