Your Guide to Radiopharmaceutical Cleanroom Design

Your Guide to Radiopharmaceutical Cleanroom Design

by | Mar 14, 2022 | Pharmaceutical Cleanrooms

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. 

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What to Expect from the Cleanroom Design Process

What to Expect from the Cleanroom Design Process

by | Mar 7, 2022 | Cleanroom Design

If your facility has decided to invest in a new cleanroom, it can easily become an overwhelming task. Not only is it difficult to find the information you need, but it’s also difficult to understand when you do find it, as it’s often written in highly technical jargon. 

Luckily, there are a lot of people out there willing to help you so you don’t have to take on the cleanroom design process alone, including the team at Angstrom Technology. Below, we’ve put together some information on what to expect from the cleanroom design process, and how working with a team of cleanroom design experts can help you better accomplish your goal.

10 Things to Consider During the Cleanroom Design Process

For starters, there are many components to consider before you even start preliminary cleanroom designs. You need to have a good understanding of what your application requires so that you know the basics of what you’re looking for from a cleanroom. 

Below are ten key considerations you’ll have to make at the start of the cleanroom design process. A cleanroom design and installation company can definitely help you figure out specifics, but they’re good things to be aware of before you even walk into the initial consultation. 

1. Cleanroom Classification

Of course, the most prominent characteristic of a cleanroom is that it’s clean. Every cleanroom has an ISO classification, which is based on the maximum number of allowed particles, air change rate, and airflow velocity within it. If you’re not sure what classification your cleanroom needs to meet, it’s best to look at what’s common within your industry. 

2. Cleanroom Size

Your cleanroom needs to have enough space to accommodate the equipment, personnel, materials, and any other additional features you need to include within it. Therefore, it’s important to accurately measure the dimensions of the space in which you plan to install your cleanroom. Make sure to account for any structural components that could affect the length, width, or height of the space. 

3. Cleanroom Location

The location in which your cleanroom is installed will affect your design process. For example, you’ll need to know whether you’ll be building a standalone cleanroom, or if you’ll be utilizing the existing building structure to support the cleanroom. In addition, you’ll need to be aware of and mindful about how much overhead clearance you have. For the majority of cleanroom applications, an overhead clearance of 12 feet is standard to ensure the fan filter units above can do their jobs effectively, and that you have the clearance for a ceiling plenum to recirculate air. 

This consideration may also provoke you to think about things like access to utilities, water sources, and power, how level your ground is, how to bring materials in and out of the facility, etc. 

4. Temperature & Humidity

Depending on your cleanroom application, you may or may not need temperature and humidity specifications. Most standard designs allow for 68°F with ± of 5°F and 60% relative humidity (RH). However, if your application requires something different or more stringent controls, you may need to include a more robust air handling unit, controls, and technologies within it. 

5. Static

Some cleanroom applications, such as electronics manufacturing, could be disrupted by higher levels of electrostatic discharge (ESD). If ESD could disrupt your production, damage your products, and/or cause harm to your cleanroom operators, you may need to consider installing a static elimination ceiling system to keep it under stricter control or standard operating procedures to protect personnel.

6. Lighting Levels & Color

If your cleanroom application deals with very small objects, you may need a brighter lighting option to effectively complete tasks. Or, if your cleanroom application and process are sensitive to lighting, you may need to account for different lighting fixtures.

7. Material & Personnel Flow

How will your personnel and products go about entering the cleanroom, exiting the cleanroom, and everything in between? The process flow within your cleanroom is an important factor to keep in mind, so you can ensure your designs allow for proper furniture and equipment placements, and enough space for material storage, personnel operations, etc. 

8. Wall Systems & Flooring Material

Cleanrooms are available with three different wall types: HardWall, SoftWall, and RigidWall. You should become familiar with each type, as well as any windows, viewing panels, pass-through chambers, or equipment you may need to install within them. 

Additionally, although it’s a frequently forgotten cleanroom component, there are three different flooring types: perforated raised flooring, seamless vinyl, and epoxy paint on concrete. 

9. Fire Protection & Rating

Depending on your application, your cleanroom must meet a certain fire rating. In particular industries, fire safety and defense are incredibly important, and it’s critical to take all precautionary measures needed to protect your property, products, and people. 

In fact, depending on the type and size of cleanroom you choose to install, your local municipality and their codes may play a significant role in whether or not you need a fire suppression or sprinkler system implemented as well. 

10. Additional Equipment & Furniture

Every cleanroom application requires unique equipment to get the job done efficiently, accurately, and safely. If you know the list of specific equipment and cleanroom furniture you need, it’s easier to account for them early on, avoiding any disruptions or pauses in the design process. 

Why Work with a Team of Cleanroom Design Experts?

It can be challenging to ensure all this information is appropriate and accurate on your own — and it’s just as difficult to bring it all to fruition! That’s why it’s beneficial to talk to a team of cleanroom design experts, letting them take the introductory information you provide them and run with it. 

Experienced cleanroom designers will be able to provide you with various cleanroom design options to get what you need, so that you can narrow them down to what will work best for you based on your facility’s goals and budget. They’ll educate you on different design aspects before you make a decision, so you can be sure you’re making the right one.

The bottom line? Cleanroom designers will guide you through each component you need to consider, provide informed recommendations that help take the stress out of decision-making, and streamline the design process so your cleanroom is constructed according to your project timeline. 

Choose Angstrom Technology For Your Cleanroom Design

Hoping to design and install a cleanroom within your facility? Let the experts at Angstrom Technology help! Our team is experienced in all aspects of cleanroom design, and we’ve successfully completed countless projects for clients in various industries. We’ll listen to your needs, guide you through each step of the process, and deliver a spectacular cleanroom that allows you to complete your work safely, efficiently, and effectively. To get started working with us, contact our team online. 

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Cleanroom Installation FAQs

Cleanroom Installation FAQs

by | Feb 25, 2022 | Cleanroom Installation

Looking for more information about the cleanroom installation process? You’re in the right place. Below, we’ve answered ten of our most frequently asked questions regarding cleanroom installation, so you can gain a better understanding of what the process involves. 

How Much Space Will My Cleanroom Need?

It depends. To determine the right size for your cleanroom, you’ll want to consider how much space you’ll need to adequately house your operations. Consider the appropriate amount of space for factors like equipment, workers, and walkways in which workers can move around. 

You’ll also want to keep vertical space in mind. In order to accommodate fan filter units which sit approximately 12-15” inches above the ceiling grid, and to make sure they can function correctly, you should allot for 24”-36” inches overhead clearance. This will ensure that there’s enough space for the filters to obtain air, and for your workers to carry out regular maintenance tasks. 

One other major factor to consider? Only use the space you absolutely need. If you install a cleanroom that’s bigger than what your application requires, you’ll just waste time and money. 

Are Modular Cleanrooms Easier to Install? 

Yes. Modular cleanrooms are built with prefabricated and pre-wired components that are precise and ready to install upon delivery. This generally makes the installation process much easier and quicker than that of traditionally built cleanrooms. 

How Much Does It Cost to Install a Cleanroom?

Cleanroom installation costs vary from project to project. In most situations, the cost depends on the following factors: 

However, there’s one way that you can drastically cut down your cleanroom installation costs, regardless of any of the factors listed above: build modular. Building with prefabricated, pre-wired components results in a much faster installation, reducing labor costs. 

Can I Install a Cleanroom in an Existing Space and/or Around Existing Equipment?

Yes and yes! It can be difficult to decide where to install your cleanroom, but the bright side of that is that you do have choices. Modular cleanrooms can be installed in most existing buildings as free-standing structures, or they can be tied into the existing building (this all depends on the footprint, obstructions within the facility, and structural integrity of the existing building). Modular cleanrooms are so versatile that they can even be installed around an existing piece of equipment within your facility if need be. 

Interested in seeing this in action? Check out our case study about the pharmaceutical packaging cleanroom we built around a large piece of existing equipment for Praxis, a West Michigan-based contract packaging company. 

Can I Use My Own HVAC System?

Yes, your cleanroom can be connected to your facility’s existing HVAC system — as long as it can handle the new load your cleanroom requires and guarantee it will meet the required temperature and humidity specifications without an issue. While integrating with your existing HVAC system is generally the most economical way to go, the majority of cleanrooms, no matter the ISO classification, will need more capacity and additional features than your existing system can handle. Therefore, it is best to have an independent, dedicated cleanroom HVAC system installed. 

Do I Have to Install My Cleanroom on My Own, Or Can Somebody Do It for Me?

You don’t need to install your own cleanroom. At Angstrom Technology, we employ a team of experienced cleanroom construction specialists that can come out, install your cleanroom for you, and ensure all the details are right. That way, you’ll suffer minimal disruption to your work day and operations while we get the job done for you. 

How Long Does the Cleanroom Installation Process Take?

Although the modular cleanroom installation process can vary based on the size and complexity of your design, it’s usually very quick. Prefabricated modular components are made for a high level of efficiency, reducing between 25-75% of labor time when compared to traditional cleanrooms. 

Once you’ve completed your cleanroom design and once all the prefabricated components have been delivered, the installation process usually only takes a few weeks, and some smaller cleanrooms can be installed in just days! 

When Can I Start Using My Cleanroom After It’s Installed?

Once installation is complete, there are a few things you need to do before you can start operating within it. First of all, you should ensure that all of your equipment, machines, and materials are in it, in the right spaces and are operating as intended. Then, you need to get your cleanroom air balanced, cleaned, certified, and validated so that you can ensure it’s meeting the conditions required by your ISO classification. After those steps, you should be ready to start operations!

How Can I Keep My Cleanroom in Good Condition Once It’s Installed? 

The best way to keep your cleanroom in good condition post-installation is to keep up with regular cleanings and maintenance tasks. Not only do most cleanrooms require daily cleanings, but they also require frequent filter inspections and replacements. You can find a more detailed list of maintenance tasks here. 

Can I Expand My Cleanroom in the Future?

Yes. Modular cleanrooms are extremely versatile, so they can easily be downsized, expanded, and reconfigured whenever you need. No matter what the changing needs of your facility may be, a modular cleanroom can keep up with them and offer a long-lasting investment. 

Have more questions about installing a cleanroom in your space? Give the experts at Angstrom Technology a call! We’d be happy to walk through your specific requirements and help design and build the best cleanroom for you.

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All About Medical Packaging Cleanrooms

All About Medical Packaging Cleanrooms

by | Feb 23, 2022 | Medical Laboratory Cleanrooms

There are a lot of steps that go into the safe research, testing, and production of medical products — but the process doesn’t stop there! Once medical products are tested and manufactured, they need to be packaged and distributed safely as well. 

That’s where medical packaging cleanrooms come in. Below, we’ll discuss these spaces in further detail, giving information about what they are, what requirements they have, and what projects Angstrom Technology has been working on lately. 

What Is a Medical Packaging Cleanroom?

As its name suggests, a medical packaging cleanroom is a controlled, filtered space dedicated to the packaging of sensitive medical materials and products. However, this is a pretty broad term given the number of medical materials and products available. 

As we’ve covered in our previous blog, there are three main types of medical cleanrooms: those for medical research, those for medical devices, and those for pharmaceuticals. Therefore, medical packaging cleanrooms are usually built to accommodate medical device packaging, pharmaceutical packaging, or both. 

What Requirements Does a Medical Packaging Cleanroom Need to Meet?

Depending on the specific type of medical product that needs packaging, one medical packaging cleanroom may have different requirements than the next. But there are still some things they all have in common. Below are a few common considerations for medical packaging cleanroom requirements:

Size

In many cases, medical packaging applications involve large pieces of equipment like packaging lines and conveyor belts. Therefore, medical packaging cleanrooms tend to be relatively larger than cleanrooms in other industries, in terms of both floor space and height. 

ISO Classification

Medical packaging cleanrooms require a good level of filtration and cleanliness, but they usually don’t need to meet the most stringent ISO standards. Since they’re mainly focused on the packaging of the product, rather than the actual production or testing of it, they’ll usually fall into ISO Class 7 or 8 range. 

Additional Design Features

When it comes to medical packaging cleanrooms, the additional design features and technologies needed vary from company to company and application to application. However, most include gowning rooms, a material airlock, and at least one area for parts storage. 

Angstrom Technology’s Recent Medical Packaging Cleanroom Projects

At Angstrom Technology, we’ve completed a number of cleanroom projects within the medical industry — but recently we’ve been excited to share some of our unique medical packaging projects! Completed within the past couple of years, these projects have ensured consistently controlled operations for our clients and have even resulted in some long-term relationships and additional projects. 

Medical Packaging Cleanroom 

In 2021, Angstrom completed a huge, 32,000 square foot cleanroom project for a medical packaging company in West Michigan — in just four months! The cleanroom is now able to fit numerous large pieces of medical packaging equipment, as well as the large number of workers needed to operate them. It also features the following specifications and technologies: 

  • ISO Class 8
  • Seamless Construction
  • 24’ Suspended Walkable Ceilings
  • High-Speed Roll-Up Doors
  • Automated HEPA Controls & Pressure Sensors Linked to BMS through BACnet

To view featured videos and photos from this project, visit our Medical Packaging Cleanroom Project page. 

Pharmaceutical Packaging Cleanroom 

Back in 2019, Angstrom worked with Praxis, a Michigan-based, contract packaging company, to design, build, and install a 2,120 square foot cleanroom for their OTC and prescription pharmaceutical packaging applications. This project brought a unique challenge to our team because the cleanroom needed to be designed and installed around a large piece of existing equipment in the facility — and on a tight timeline. 

But by employing two expert crews to handle the job, Angstrom was able to deliver a quality cleanroom solution on time, eventually resulting in Praxis becoming a long-term customer and requesting two more identical pharmaceutical cleanroom projects. Specific cleanroom features and technologies are listed below: 

  • ISO Class 8
  • Gowning Room and Parts Storage Room (both ISO Class 8 as well)
  • 14’ Internal Ceiling Height
  • Epoxy Floor

To discover more details about this project, read our case study that was featured on Cleanroom Technology’s website. To view featured videos and photos from this project, visit our Pharmaceutical Packaging Cleanroom Project page. 

Hoping to install a medical packaging cleanroom in your facility? Contact Angstrom Technology! Our engineers have nailed down processes for design, building, and installation that are both efficient and effective. We’re excited to take on any challenges your cleanroom project may present. And, with an extensive portfolio of successful projects, we’ve proven our ability to achieve quality, consistent results. 

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What Are Radiopharmaceuticals?

What Are Radiopharmaceuticals?

by | Feb 21, 2022 | Pharmaceutical Cleanrooms

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 Life Sciences 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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