Your Guide to Radiopharmaceutical Cleanroom Design

Your Guide to Radiopharmaceutical Cleanroom Design

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. 

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What Are Radiopharmaceuticals?

What Are Radiopharmaceuticals?

Here at Angstrom Technology, our experts have recently put the finishing touches on another exciting project: a radiopharmaceuticals cleanroom! 

Not sure what a radiopharmaceuticals cleanroom is, or what it entails? We’ll walk through the details below. 

What Are Radiopharmaceuticals?

Radiopharmaceuticals are a group of pharmaceutical drugs that contain radioactive isotopes. In most cases, they’re used as diagnostic agents that help doctors detect a variety of medical problems. After a patient is given a small amount of a radiopharmaceutical drug, it either passes through or is absorbed by the intended organ. Then, once the radioactivity is detected, special imaging equipment is used to take pictures that allow the doctor to study how the organ is functioning. 

In addition to that very cool application, radiopharmaceuticals are also gaining recognition and popularity as a viable form of therapy or treatment for certain types of cancer, among other life-threatening diseases. In those cases, the radiopharmaceutical drug is absorbed in the cancerous area and works to destroy any affected tissue. 

That said, radiopharmaceuticals (especially those used for therapeutic and treatment purposes) make up a relatively new sector within the medical and pharmaceutical industries. The number of radiopharmaceuticals in clinical use continues to grow rapidly, allowing the medical community to better understand different diseases, as well as the best treatments for them. 

Key Considerations for Radiopharmaceuticals Cleanrooms

Just like any other pharmaceutical or medical cleanroom project, radiopharmaceuticals cleanrooms require the same basic considerations to get started: 

  • Budget
  • Size
  • Type
  • ISO classification

However, they also present a unique challenge. In traditional pharmaceutical applications, the main purpose of a cleanroom is to protect drugs from any contaminants that could reduce their safety or effectiveness. While that’s still important in radiopharmaceutical applications, there’s another huge component to consider: the safety of cleanroom operators and facilities. 

Radiopharmaceutical drug production requires a highly controlled environment that’s properly equipped to store, prepare, fill, and pack radioactive materials safely. This often means implementing a number of specialized machines and technologies, including (but not limited to) access control systems, isolators, fume hoods, and hot cells. 

The bottom line is that, after everything is designed, constructed, and installed, all components should work together to ensure the safety of both the drugs being handled and the people handling them. 

Angstrom Technology’s Latest Radiopharmaceuticals Cleanroom Project

Our recent radiopharmaceuticals cleanroom project, completed in October 2021, was for an advanced radiopharmaceuticals research and development company with a focus on cancer treatment. Based in Grand Rapids, Michigan, this cleanroom totaled 3,200 square feet and held 17 internal rooms for various operations. Below are more details on the project: 

  • Cleanroom type: HardWall
  • ISO classification: ISO 7 & ISO 8
  • Internal ceiling height: 10’
  • Additional design features and technologies: extensive door and access control system, isolators, hot cells

To view the project video and featured images, visit our Advanced Radiopharmaceuticals Cleanroom Project page. 

If you’re interested in learning more about the unique cleanroom projects we’ve completed here at Angstrom Technology, check out our Projects page. Or, if you’re ready to get started on your own cleanroom project, get in touch with our team. We’re happy to guide you through our proven design, building, and installation processes, ensuring you a final result that accommodates the needs of your facility and application. 

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New Trends in Cleanroom Design

New Trends in Cleanroom Design

Now that the holidays are over and the new year has begun, you might finally be getting around to implementing a new cleanroom in your facility. If you’re designing a new cleanroom or updating your current one, here are the latest trends in cleanroom design that you should consider as you design your cleanroom space.

 

Sustainability

Sustainability is an important consideration for all of us, including corporations. Because cleanrooms use so much energy to maintain the desired environmental conditions, engaging in sustainable practices when possible is crucial. Not only do these sustainability efforts support the natural environment, they are also energy efficient, which can help you save on energy costs. Using energy efficient equipment and energy efficient LED lighting can aid in sustainability efforts, as can a modular cleanroom. Modular cleanrooms can be altered and right-sized as the needs of your company change, while reusing the modular components, and require less material than traditional construction. Additionally, modular cleanrooms can make use of the currently existing HVAC and ventilation systems in your space, rather than requiring separate systems.

 

Transparency

Now, more than ever, we’re aware of the value of transparency from leaders and companies. When it comes to your cleanroom, the primary concern will always be the integrity of the controlled environment within, and it may also be important to maintain privacy for the safety of intellectual property, but cleanrooms can benefit from some openness and visibility. Using transparent partitions in the place of opaque walls can provide some benefits, the biggest of which being that lab processes can be observed, whether by compliance regulators or supervisors within your organization, without disturbing cleanroom processes or the environment within.

 

Flexibility

Many organizations are resisting the use of specific dedicated spaces for certain tasks or operations, instead opting for more shared spaces and flexibility in order to reduce costs and under-utilized space. This means incorporating fixtures and furniture, such as lab benches and workstations, into your cleanroom that can accommodate a variety of tasks or processes, as well as modular cleanrooms that can be easily expanded, contracted, or reconfigured to maximize use of space.

 

As you’re working on your cleanroom design or redesign, consider the needs of your company and your cleanroom, as well as how the cleanroom can continue to meet those needs over time, with organizational and regulatory changes. Incorporating sustainability, transparency, and flexibility into your cleanroom design can make your cleanroom efficient and future-proof, not matter the changes to come.

Looking to design a new cleanroom? Get in touch with the cleanroom experts at Angstrom Technology.

Benefits of Cleanroom Pass-Through Chambers

Pass-through chambers are a commonly used cleanroom term, and they’re also an ideal addition to just about any cleanroom. They’re easy to install, they don’t draw much out of your budget, and they hold tons of benefits for the operation of your cleanroom. While there are all types of pass-through chambers, from basic transaction windows to industrial roll-up door pass-throughs, most cleanroom pass-throughs fall into the dual-door category. Because the removal of contaminants is any cleanroom’s top priority, most cleanroom pass-through chambers have two doors, one on the outside and one on the inside of the cleanroom. Those cleanrooms that must meet higher standards often install pass-throughs with additional features like an air shower or fire resistance, but the general construction and operation is the same.

What are the benefits of cleanroom pass-through chambers?

  • They allow your employees to transfer materials in and out of your cleanroom without contamination.
  • They make it easy for employees to pass materials into the cleanroom without having to gown. This also cuts down on the number of employees in your cleanroom at any one time.
  • They come in a variety of sizes and materials, ensuring you get the pass-through that meets the needs of your employees. Stainless steel options are corrosion-free, which extends the life of your pass-through, and helps keep your cleanroom clean.
  • Double door designs ensure cross contamination doesn’t happen. And heavy duty sealing lock features keep contaminants out of the chamber when it’s not in use.
  • Most pass-through chambers are customizable, allowing you to choose the option that best fits the needs of your cleanroom. Whether you need a fire safe option, one that’s chemical resistant, or a pass-through chamber that includes a blower with HEPA filtered air, you can choose the chamber that best suits your cleanroom needs, ensuring you benefit from a pass-through chamber, regardless of your cleanroom classification.

How do cleanroom pass-through chambers increase productivity?

The single greatest benefit of a cleanroom pass-through chamber is its ability to speed up your processes and increase employee productivity. Pass-through chambers eliminate the need for employees to properly gown to enter a cleanroom environment just to hand off a necessary item or sample. As you likely know, the gowning process can be time-consuming, and additionally, the more employees you have in a cleanroom, the greater the chance for contamination. When employees can simply place materials in the pass-through chamber, you save a great deal of time on both sides of the cleanroom. Best of all, pass-through chambers are easily installed, whether you have an existing cleanroom or you’ve just commissioned a new one.

Who uses pass-through chambers?

The benefits of pass-through chambers are clear. They boost productivity without sacrificing cleanliness. So, which cleanroom industries use pass-through chambers, and how?

Research Facilities

Because research facilities often study new and unpredictable chemicals and substances, they need pass-through chambers for safety more than for convenience. Because some chemicals can easily become volatile and cause fires, fire safe pass-throughs are commonly used in this application. These pass-through chambers can withstand fire exposure for up to 90 minutes, and their sturdy construction maintains frame shape that protects research labs from destruction. While these labs also often make use of air shower pass-throughs to decontaminate materials before they’re introduced to the lab, fire safe pass-throughs are the most common.

Medical and Pharmaceutical cleanrooms

Decontamination is the first priority of both medical and pharmaceutical cleanrooms. Because hospital laboratories often deal with highly contagious substances, it’s paramount that the environment remains sterile. In the same vein, pharmaceutical cleanrooms have to ensure there is absolutely no contamination in the manufacturing process that could alter their product. In both cases, these cleanrooms require pass-through chambers that keep samples, specimens, and other materials sterile as they’re brought into the cleanroom. These industries typically make use of a standard two door pass-through chamber that keeps outside contaminants from entering the cleanroom and ensures the materials remain sterile as they’re waiting to be brought in.

Electronic and technology manufacturing cleanrooms

Manufacturing facilities that put together the complex inner workings of technological devices like computers and smartphones require very strict cleanroom environments that filter out even the smallest particles of dust and other contaminants. Just one tiny particle settling on a single piece in the manufacturing environment could render a future hard drive useless. Many electronic and technology manufacturing cleanrooms opt for highly monitored pass-through windows in order to maintain the sterility necessary to produce quality electronic products while maintaining a high level of productivity.

 

Pass-through chambers are a highly useful component of any cleanroom. They help you ensure that you keep your processes moving, while maintaining the high standard of cleanliness within your cleanroom. If you’re installing a new cleanroom, or even if you’re considering adding a pass-through chamber to your existing cleanroom, be sure to give the experts at Angstrom Technology a call! We’ve been manufacturing top-of-the-line cleanrooms for years and would be more than happy to help you find the pass-through best for your operation. Call our office at 888-768-6900 or contact us online today!

What You Need to Know About Cleanroom Classifications

What You Need to Know About Cleanroom Classifications

If you’re installing a cleanroom within your company for the first time, all of the information associated with the process can be a bit overwhelming. There are a whole variety of new terms, you have to decide where to put your cleanroom, how big to make it, how to do it all on budget, and what’s worse: you have to figure out what standards to adhere to. Cleanroom classifications are one of the most confusing parts of cleanroom construction. If it’s your first time commissioning one, it can almost seem like dealers are speaking another language, and no one makes it quite clear what a cleanroom classification really means. We thought we’d take a minute to explain what goes into cleanroom classifications and standards, so you have a better idea of what you’re working with when you get to commissioning your cleanroom design. Here’s everything you need to know about cleanroom classifications, from deciding what standard to adhere to, to figuring out how to do it cost-effectively:

What’s your application?

The very first thing to know about cleanroom standards is which one is required for your application. Every industry has different requirements and needs, from electronics manufacturing to food preparation, and some are more strict than others. It’s important that you know exactly which classification is required of your industry, because if you install a cleanroom that’s designed to the wrong specifications, you’ll either be spending too much money on an overpowered cleanroom, or your product will suffer from the excess contamination. If you’ve been contracting with a private firm for a while, or if your industry is regulated by a government agency, it’s a good idea to check with them to see what classification you should design your cleanroom for. They’ll have documentation on the standards their labs function to, and should be able to give you plenty of information regarding what’s necessary, what’s recommended, and what you don’t need to worry about when designing your own cleanroom.

What’s a cleanroom classification?

Cleanrooms are classified by the number of contaminants that exist in a functioning cleanroom. Contamination is measured in parts per cubic meter.  Say, for example, that your cleanroom has to measure up to an ISO Class 6 level, which is rated at 35,200 parts per cubic meter. This means that within your cleanroom, you can have no more than 35,200 particles greater than .5 microns in size, per cubic meter of cleanroom space.  For reference in size, the typical measurement for the end of a piece of human hair can be anywhere from 60 to 100 microns in size. A particle that’s as small as .5 microns in size cannot be seen by the human eye, which is why we need high-quality filters to contain them.

ISO standards

The current accepted standards for cleanroom classifications are ISO (International Standards Organization) standards. This is the classification system most widely accepted internationally, and the U.S. just switched to this standard officially in 2001. It’s likely that while you’re doing research on your new cleanroom, you’ll come across a classification called the Federal Standard 209E, which was the previous accepted American standard for cleanrooms. These federal standards were officially cancelled in 2001, but many people in the industry still reference them. It’s just important to know that in today’s world, your cleanroom will have to measure up to a certain ISO standard, rather than a federal one.

There are nine ISO classes: Class 1 (the cleanest) to Class 9. The lower the ISO class rating, the cleaner the environment. ISO standards created three new classes that the Federal Standard did not address, making it the more comprehensive classification system. It’s best to refer to ISO whenever possible, because it’s internationally recognized and will limit any confusion. Here’s a better look at what each ISO Class looks like, as well as how they measure up to the old Federal Standards:

ISO 14644-1 Cleanroom Standards
Classmaximum particles / m3FED STD 209E

equivalent

≥0.1 µm≥0.2 µm≥0.3 µm≥0.5 µm≥1 µm≥5 µm
ISO 1102.371.020.350.0830.0029
ISO 210023.710.23.50.830.029
ISO 31,000237102358.30.29Class 1 Cleanroom
ISO 410,0002,3701,020352832.9Class 10 Cleanroom
ISO 5100,00023,70010,2003,52083229Class 100 Cleanroom
ISO 61.0×106237,000102,00035,2008,320293Class 1,000 Cleanroom
ISO 71.0×1072.37×1061,020,000352,00083,2002,930Class 10,000 Cleanroom
ISO 81.0×1082.37×1071.02×1073,520,000832,00029,300Class 100,000 Cleanroom
ISO 91.0×1092.37×1081.02×10835,200,0008,320,000293,000Room air

(µm denotes micron particle size)

*Chart courtesy of PortaFab

Know how standards apply to your cleanroom’s 3 different states

So now you know what classification your cleanroom has to adhere to, it’s important to understand how that is measured by inspectors. Basically, your cleanroom has three different states: As built, at rest, and operational. The first refers to how your cleanroom performs just after it’s built–without furniture, employees, equipment, or machinery. Cleanroom certifications for cleanliness given by manufacturers refer to this as built state. At rest is your cleanroom once you have all of your equipment moved in, but before your processes are up and running. At this point, the workers have yet to move in, but your supplies and machinery are likely creating a bit of contamination just sitting in your room.

The third state refers to your cleanroom once you’re finally running processes with employees. This is going to change the level of contamination within the cleanroom the most, as people tend to shed a multitude of particulate, and machinery can often cause disruptions in airflow and give off contaminating fumes. It’s important to understand that once you get everything working, you’re going to have more particulate circulating your cleanroom than what your cleanroom standard calls for. Keep this in mind as you begin designing your ideal cleanroom, and make adjustments to allow for the extra particulate that will inevitably contaminate your cleanroom once you get people and machines moving.  

Understand how a cleanroom works

Now that you know what the classifications are and how they’re measured, we’ll dive into how you get your cleanroom to meet those standards. To do that, it’s important to know how cleanrooms function. The great majority of cleanrooms exist on a positive pressure method. That means that air is pumped into the room through high-powered HEPA filters that remove the necessary contaminants. The air then flows down, and is pushed out through vents in the floor. The idea here is that any particles that exist in the cleanroom are forced out of the room by flowing air. Because positive pressure cleanrooms have higher air pressure than the rooms surrounding them, air flows from the cleanroom into the other rooms, which forces contaminated air from other rooms back, and away from the cleanroom.

In positive pressure clean rooms, air is constantly flowing out of the room. It’s good to know that negative pressure cleanrooms do exist, but they’re far less common. Negative pressure cleanrooms function exactly opposite of positive pressure cleanrooms, and are meant to contain dangerous contaminants like infectious diseases or hazardous substances. Air is pulled in from other rooms, is filtered within the cleanroom, and returns to the outside as clean, contaminant free air.

So how do you build a cleanroom that adheres to the proper classification?

In most cases, it all comes down to air. Most cleanrooms are structurally very similar: they feature return air grills, airtight walls, doors, and windows, and they basically function to keep clean air in, and contaminated air out. To achieve a cleaner class of cleanroom, it really all comes down to airflow. Any time you move down one class, you require about twice as much air. This is because the air is what does most of the work of ridding the space of contaminants. This is also the biggest cost associated with cleanrooms, because to get proper airflow in a cleaner class of cleanroom, you need more filters, more air return space, and generally just more air to be pumped into the space. The cleaner you need your environment to be, the greater the rate of air change.

ClassAverage Airflow VelocityAir Changes/HRRecommended
ISO Class 8Not applicable10-2020 to 40
ISO Class 7Not applicable30-7050 to 80
ISO Class 6Not applicable70-160100-180
ISO Class 5.2-.5 m/sec (40-90ft./min)Not applicable300-400
ISO CLass 4.3-.5 m/sec (60-90ft./min)Not applicable

*Chart courtesy of Simplex Isolation Systems

For lower classes of cleanrooms, ISO class 9 through class 6, cleanliness is based on the amount of air changes that happen each hour. Cleanrooms that have more stringent cleanliness requirements–Classes 5 through 1–measure the flow of air through the room in meters per second. So how fast is that air moving through the room, how is it getting out, and when the air leaves the room, is it taking contaminants with it?

This is where a cleanroom designer comes in handy. Even if you create the perfect cleanroom with top-of-the-line technology, improperly placed equipment and furniture can create dead spaces where particulates are blocked from the air flowing through the room. When this happens, more particles are sticking around in your cleanroom, messing up your processes, and potentially hurting your workflow and production abilities.

We hope this blog helps shed a bit of light on the confusing world of cleanroom classifications! If you have more questions about designing your new cleanroom to the necessary standards, be sure to get in touch with the experts at Angstrom. We’ve been designing and installing cleanrooms across the country for years now, and would be happy to help you out! Request a free quote online today, or give our office a call at 888-768-6900.

The RididWall Installation Process

Want to learn more about the Angstrom cleanroom installation process? Watch this short time-lapse video of our RigidWall system's implementation.