Cell and gene therapies are both forms of regenerative medicine. Cell therapy involves transferring live, intact cells into a patient to lessen or cure a disease. The cells may be from the patient (autologous) or from a donor (allogeneic). Gene therapy involves transferring genetic material into a patient to change how a single protein or group of proteins is produced by the cell. 

These are relatively new treatment options, but many healthcare professionals are optimistic about the safer, more targeted, less invasive way to treat serious illnesses. 

All that said, the various processes that go into developing cell and gene therapies require a controlled cleanroom environment. Tasks like cellular engineering and genetic engineering, growth, and purification all require stringent cleanliness standards, so that their results can be safe, effective, and repeatable. 

Something that can jeopardize that environmental control? The various types of equipment housed within the space. Below, we’ll talk about cell and gene therapy cleanroom equipment, what risks it can pose, and what steps you can take to mitigate those risks. 

Risks Associated with Cell & Gene Therapy Cleanroom Equipment

While designing a cell and gene therapy cleanroom, it’s important to consider the pieces of equipment that are required for your operations and how they may affect the surrounding cleanroom environment. Many pieces of cell and gene therapy equipment can emit heat and contaminants, which presents a bit of a challenge during the design process. Depending on the risk they carry, you may need to determine if this equipment should be located in a classified or external support area, or if other accommodations need to be made to ensure a high level of safety and control. 

Here are a few of the main risks associated with cell and gene therapy cleanroom equipment, along with considerations you should take to mitigate them: 

• Equipment material – Equipment should be manufactured using non-shedding materials that can withstand sanitation and decontamination practices, which could include exposure to vaporized hydrogen peroxide (VHP) and other biocides. Materials should also have low electrostatic properties in order to reduce particle adherence. 
• Equipment surface – All equipment surfaces should be smooth, with no joints, cracks, or crevices for contaminants to accumulate. Also, surfaces that come into contact with products and consumables should be non-absorbent and non-reactive. 
• Particle emission – Oddly enough, the equipment used to safely carry out cleanroom operations can be a contributor to particle emission as well. For these types of equipment, you may need to either find an external storage area, conduct additional sanitation procedures, or boost your filtration efforts. 
• Heat gain – Many pieces of cell and gene therapy cleanroom equipment can increase the temperature in cleanrooms, which means you may need to include additional cooling systems and account for the heat loads in the design. Also, when writing a user requirement specification (URS), you should include details for what equipment will be located in which area so that heat load calculations can be made easily. 
• Weight – For larger pieces of cell and gene therapy cleanroom equipment, weight needs to be considered. Make sure you have tables, workstations, and benches that meet the necessary load-bearing capacity to safely store and operate equipment. 

One final consideration you may make for cell and gene therapy cleanrooms is that they should be configured in closed-loop systems whenever possible. A closed-loop system is designed and operated in a way that doesn’t expose products to the surrounding room environment. This helps to ensure a further layer of protection against any of the equipment risks listed above. 

5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms

So what are these pieces of equipment? Well, while there are many different types of cleanroom equipment, there are a few that are most commonly used in cell and gene therapy applications. Here are just five of them, along with associated environmental hazards to be aware of. 

1. Biosafety Cabinets

Biosafety cabinets are enclosed workspaces that use laminar airflow to filter out fumes and contaminants. They help to protect cleanroom personnel and the surrounding environment from hazardous substances. There are three different biosafety cabinet classes that offer varying amounts of protection: 

• Class I – Provides protection for personnel and the surrounding environment, but not the product itself. 
• Class II – Provides protection for personnel, the surrounding environment, and the product itself. 
• Class III – Provides the highest level of protection for personnel, the surrounding environment, and the product itself. 

Although biosafety cabinets can provide great protection, they can also pose a few risks. When planning to install one in your cleanroom, it’s important to consider the following:

• Equipment surface
• Could a closed system be used?

2. Incubators

An incubator is a device that provides the optimal environment for growing and maintaining microbiological cultures and cell cultures. They regulate internal temperature, humidity, and carbon dioxide levels so that even the most sensitive of cultures are able to thrive — which is a critical part of the treatment process. 

The following environmental risks are associated with incubators:

• Equipment material
• Particle emission
• Heat gain
• Gas lines within cleanroom

3. Refrigerators

Refrigerators are used to store various cell and gene cultures in cold temperatures. These cultures and products need to be housed in continuously refrigerated conditions in order to be fully safe and effective upon reinjection. 

However, refrigerators pose the following environmental risks for cleanrooms: 

• Equipment material
• Heat gain

4. Freezers

Similar to refrigerators, freezers are used to store various cell and gene cultures in cold temperatures. They’re most often used when samples need to be stored for extended periods. It’s important that these freezers remain at their required temperature because dropping too low or rising too high could compromise the cultures’ viability. 

Freezers pose the same environmental risks for cleanrooms as refrigerators: 

• Equipment material
• Heat gain

5. Centrifuges

A centrifuge is a machine used to separate the various components of a fluid. In cell and gene therapy applications, it’s typically used to isolate strains of cells or DNA. Centrifuges are typically large in size and heavy in weight, often requiring a heavy-duty bench to sit upon. 

If you’re planning to install a centrifuge in your cell and gene therapy cleanroom, you should be aware of these potential hazards:

• Equipment material
• Heat gain
• Weight

Planning to install a cell and gene therapy in your facility? Angstrom Technology can help. We’ll ensure your cleanroom is outfitted with the right equipment and technologies — and it’s capable of mitigating any risks that come with them. To get started working with us, contact us today. 

The cleanroom component that plays the most integral role in a space’s cleanliness and performance is its filtration system, which consists of either ULPA or HEPA filters. Let’s discuss the differences between these two types of filters, so you have a better idea of which one may be best suited for your cell and gene therapy cleanroom. 

ULPA vs. HEPA Filters: What’s the Difference?

ULPA and HEPA filters both do great work catching tiny, airborne particles like bacteria, pollutants, and dust. They’re manufactured with similar technologies, but feature some differences in their filtration efficiency, airflow capacity, price, and lifespan. 

ULPA Filters

ULPA filter stands for Ultra-Low Particulate Air filter (ULPA). These filters are highly efficient and capable of meeting even the most stringent cleanliness requirements. Below are some of their standard specifications (which may or may not vary, depending on the exact size or brand of system you choose):  

• Filtration efficiency: 99.999% efficient at removing particles 0.12μm or larger 
• Airflow capacity: 20-50% lower than HEPA filters, due to denser filter
• Price: generally more expensive than HEPA filters, due to higher filtration efficiency
• Lifespan: estimated 5-8 years, depending on the surrounding environment

HEPA Filters

HEPA filter stands for High-Efficiency Particulate Air (HEPA). These filters are the most commonly used in cleanroom applications due to their quality filtration, cost-effectiveness, and longevity. Below are some of their standard specifications (which may or may not vary, depending on the exact size or brand of system you choose):  

• Filtration efficiency: 99.999% efficient at removing particles 0.3μm or larger 
• Airflow capacity: 20-50% higher than ULPA filters, due to less dense filter
• Price: generally more affordable than ULPA filters, due to lower filtration efficiency
• Lifespan: estimated 7-10 years, depending on the surrounding environment

Filtration Considerations for Cell & Gene Therapy Cleanrooms

Cell and gene therapies are practices that require a high level of control. In order to fulfill their purpose and work effectively to treat life-threatening diseases, there can be no disruption in their production process — which is why they’re usually concerned about removing smaller airborne particles between .1, .3, and .5 microns. Other cleanroom applications with less stringent requirements are typically only concerned about .5, 1, and 5 microns. This is the most important factor in determining which type of filter is best for cell and gene therapy cleanrooms. 

This also implies that most cell and gene therapy cleanrooms must meet stringent ISO standards, which are usually between ISO Class 5-7, but can be higher or lower depending on the application. For ISO 5, this means that they must have at least 240 air changes per hour, 35-70% ceiling coverage, 40-80 feet per minute of air velocity, and no more than 10,200 particles 0.3μm or larger in a cubic meter. The requirements are a little looser for ISO 7, which requires at least 60 air changes per hour, 15-20% ceiling coverage, 10-15 feet per minute of air velocity, and no more than 1,020,000 particles 0.3μm or larger in a cubic meter.

ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

So, which type of filter is right for your cell and gene therapy cleanroom? ULPA or HEPA? 

It depends on what specific tasks you’re hoping to accomplish within your cleanroom. Currently, in the world of cell and gene therapy, there are four main types of therapies:

• Cell therapy
• Gene-modified therapy
• Gene therapy
• Tissue-engineered products

Each of these therapies require a number of different sub-processes, which all require a different level of control. It’s best to determine which ISO standard your cleanroom needs to meet first and what size airborne particulates can be detrimental to your process, then choose your type of filter based on that.

But from a broad perspective, ULPA filters are generally recommended for cell and gene therapy processes, since they offer more stringent control over smaller airborne particles. HEPA filters can offer enough control for some cell and gene therapy applications, but aren’t the most commonly recommended. 

Cell and gene therapy are two fairly new, but steadily growing practices in the medical field. If you’re hoping to install a cell and gene therapy cleanroom in your facility, it’s important that you get the details right — and for that, you can trust Angstrom Technology. Our experts have experience designing, building, and servicing cell and gene therapy cleanrooms (check out our latest project!) across the globe, and we’d be happy to create a solution that meets your specific needs. Contact us online to get started. 

Cell and gene therapy are two fairly new practices within the medical field. However, they’ve recently become recognized as viable forms of treatment for various life-threatening conditions. As their popularity increases among healthcare providers worldwide, there’s been a greater push to research, develop and distribute these treatments — and in order to do that safely and effectively, cleanrooms are critical. 

Here’s a little more information about what cell and gene therapy cleanrooms are, as well as some considerations you may make before designing one of your own. 

What Is Cell and Gene Therapy? 

Cell and gene therapy are both forms of regenerative medicine. They involve extracting cells, protein, and/or genetic material (DNA) from a patient or donor, then altering the sample to provide highly personalized treatment, then reinjecting the sample into the patient. 

Although these are relatively new therapies, many healthcare providers are hopeful that they’ll offer longer-lasting effects than existing methods. They’ve also been found to be safer, more targeted, and less invasive. For patients with serious illnesses, the research and development of these therapies could be a matter of life and death.

Design Considerations for a Cell and Gene Therapy Cleanroom

Just like any other modular cleanroom, cell and gene therapy cleanrooms can be constructed as free-standing structures or supported by the existing building structure. However, the work done within them requires more complex production processes than previous medicinal applications. Things like cellular engineering, genetic engineering, growth, and purification all must be done in an even more controlled environment, so that results are sure to be safe, effective, and repeatable. 

That said, cell and gene therapy cleanrooms require some unique cleanroom design considerations, including (but not limited to) the ones listed below:

ISO Classification for Cell and Gene Therapy Cleanrooms

Most cell and gene therapy cleanrooms must meet stringent ISO standards, usually between ISO Class 5-7. For ISO 5 classification, this means that they must have at least 240 air changes per hour, 35-70% ceiling coverage, and to ensure no more than 3,520 particles 0.5μm or larger allowed per cubic meter. 

Additional Equipment and Technology for Cell and Gene Therapy Cleanrooms

Each cleanroom industry and application requires a variety of unique pieces of equipment and technology. Here are a few on the list that are often required for cell and gene therapy cleanrooms:

• Gowning rooms
• Hazardous material storage
• Laminar flow hoods, biosafety cabinets, fume hoods
• HEPA and ULPA filtration systems
• Standard, flow-through, LED strips, and other lighting options

Angstrom Technology’s Latest Cell and Gene Therapy Cleanroom Project

Want to see an example of a recent cell and gene therapy cleanroom project? Here’s some information on one built by our partners at Connect 2 Cleanrooms!

This project consisted of a full cleanroom suite that was housed within a two-story building with 33 internal rooms. It featured high levels of filtration and cleanliness, along with a variety of unique features, including:

• ISO 5 classification (equivalent to EU GMP Grade B)
• HEPA filtration 
• Fire-rated active pass-through chambers
• Vaporized hydrogen peroxide (VHP) cabinets
• Integrated medical gas systems
• Cryostorage

Read more about this project on our Cell & Gene Therapy Cleanroom Suite project page. 

Cell and gene therapy is a fast-growing industry! If you’re looking to install a cleanroom for your cell and gene therapy application, reach out to our team at Angstrom Technology. Our cleanroom design experts are happy to help you create the controlled space you need to continue researching, developing, and distributing these life-saving treatments. 

1. What Is a Modular Cleanroom?

A modular cleanroom is a cleanroom built of prefabricated components that are quickly and easily assembled to meet your specifications on-site. The prefabricated components are manufactured off-site, then delivered ready for installation, which allows for controlled conditions and improved quality and precision. 

Modular cleanrooms are able to meet any cleanliness and classification standards your application requires. They’re also easily reconfigured based on your facility’s changing needs.

2. Do I Need a Modular Cleanroom?

Modular cleanrooms are used in a variety of industries, for a variety of applications. If you need a space that is clean, safe, and virtually contaminant-free in order to successfully execute any of your processes, you’ll probably want to consider investing in one. It will keep your people, products, and property safe, so you can continue to run a profitable business. 

To provide some examples, here are a few of the industries that we commonly work with here at Angstrom Technology: aerospace & defense, agriculture, automotive, biotech, environmental testing, medical (hospital, medical device, research, marijuana), microbiology, pharmaceutical manufacturing, plastic injection molding, semiconductor. 

3. How Long Does a Modular Cleanroom Take to Design, Build, and Install?

Although the modular cleanroom design, build, and installation process can vary based on the size and complexity of your design, the process is usually very quick — especially when you compare it to that of traditionally built cleanrooms

Most often, framing, drywall, and painting are the worst trades in terms of efficiency. But with prefabricated modular construction systems, those are replaced with a high level of efficiency. In fact, prefabricated panels can result in a 25-75% schedule reduction compared to traditional construction.

At the start of the process, it may take a couple of weeks to consult with a designer about your application’s needs and create a design. After that, you’ll wait for a brief delivery period (6-8 weeks with Angstrom’s industry-setting standard). Once all components are delivered, your modular cleanroom can be installed in just a few weeks, depending on the size. 

4. How Much Does a Modular Cleanroom Cost?

The cost of a modular cleanroom is highly competitive to that of a traditionally constructed cleanroom — primarily due to the fast and simple design, build, and installation process. In addition, there’s a tremendous reduction in the costs of waste, unused materials, and lost items that are associated with traditional construction.

That said, modular cleanroom costs can vary tremendously from project to project. In most cases, the cost of a modular cleanroom is based on the following factors:

• Size
• Type (SoftWall, HardWall, RigidWall)
• Classification
• Design complexity
• Additional features

5. What Are the Benefits of Modular Cleanrooms?

Modular cleanrooms bring the same benefits as traditionally built cleanrooms — and more! In fact, when compared to their traditional counterparts, modular cleanrooms are generally:

• Quicker and easier to install, ensuring that you’re able to resume regular operations in no time. 
• More adaptable to your facility’s changing needs, as modular cleanrooms can be constructed and/or reconfigured to fit any space, even within an existing building. 
• More affordable, due to prefabricated components and a speedy installation process. 

6. What Should I Expect From the Modular Cleanroom Installation Process?

As mentioned in Question #2 above, the modular cleanroom installation process is quick — and, if you’d like to, you can save on labor costs and do it yourself! At Angstrom Technology, we’ll send you a detailed list of installation instructions to follow. 

However, if you’re worried about the technical details, we’re also happy to complete the installation process for you. We employ an experienced team of modular cleanroom construction specialists who will install your room for you, leaving you with minimal disruption to your workdays. We’ll get things done and pay close attention to the details so you don’t have to. 

7. How Do I Know Which Type of Cleanroom I Need?

There are three common types of cleanrooms: HardWall, SoftWall, and RigidWall. The type you need depends on what you plan to use it for. 

• HardWall cleanrooms are made of an aluminum frame and prefabricated solid panels. They suit most applications but are especially helpful for those with stringent cleanroom classification requirements. 
• SoftWall cleanrooms are made of an aluminum frame and vinyl curtains around the perimeter. They’re capable of meeting most cleanroom classifications, but not the most stringent — especially when it comes to temperature and humidity control. 
• RigidWall cleanrooms are made of an aluminum frame and clear, acrylic panels — giving them the durability and security of a HardWall cleanroom, plus the visibility of a SoftWall cleanroom. 

If you’re still unsure which type of cleanroom may best suit your application, it’s best to contact a cleanroom expert. They’ll listen to your needs and propose a solution that is sure to meet them. 

8. How Do I Know Which Cleanroom Classification I Need?

Your cleanroom is required to meet a certain ISO classification. ISO classification determines the degree of cleanliness, which is defined by the maximum amount of contamination allowed, by particle count and size. More stringent ISO classifications (i.e. Class 1-5) require higher filtration and air change rates. Less stringent ISO classifications (i.e. Class 6-9) are a little more lenient, working themselves all the way down to normal room air. 

For example, pharmaceutical cleanrooms require a stringent ISO classification because it’s a high priority to ensure products are kept safe so that, in turn, their consumers are kept safe. When even the smallest particle could affect the performance of a drug, there is no room for contamination or error. 

9. How Does Cleanroom Classification Affect Cost?

Generally, the more stringent your cleanroom classification, the more you’ll pay. This is because more stringent classifications require more filtration — and in order to achieve that, your cleanroom will need to accommodate more fan filter units and additional features like gowning rooms, air showers, etc.

10. Will My Modular Cleanroom Need Any Additional Features? 

Some modular cleanrooms just require the most basic components. However, modular cleanrooms that need to meet stringent classification requirements may require additional features and technologies to successfully avoid contamination. Things like airlocks, air showers, pass-through chambers, and gowning rooms are important considerations to keep sensitive applications free of harm. 

Have more questions about modular cleanrooms? Give the experts at Angstrom Technology a call! We’d be happy to walk through your specific needs and help to design, build, and install the best modular cleanroom for your facility.

Cleanroom classification is often one of the most confusing parts of designing and building a cleanroom. However, it’s also one of the most essential parts, so it’s important that you understand all the relevant information.  If you’re installing a cleanroom for the first time, you probably understand that every type of cleanroom requires a different classification, but you’re bound to have a number of other questions — and that’s okay! We’re here to help. Below, we’ll provide answers to some of the most common cleanroom classification questions we receive.

1. What are cleanroom classifications?

Cleanroom classifications regulate a cleanroom’s degree of cleanliness. They’re defined by the allowed amount of contamination, by particle count and size, as well as the air change rates necessary to maintain that.  There are a variety of classification types that regulate cleanroom cleanliness, but the main system was developed by the International Standards Organization (ISO). ISO classifications apply to all cleanroom industries and applications, and range from Class 1 (most clean) to Class 9 (least clean, regular room air). 

2. What cleanroom classification do I need?

It depends on your industry and application. The requirements will vary depending on the size of particles that need to be filtered, the sources of contamination present, and the recommended air change rates. If your industry is regulated by the government, you can check applicable regulations to see what cleanroom classification is required. If you work in a sector that isn’t regulated by the government and that doesn’t have an industry default, you’ll need to determine the appropriate classification for yourself, based on your application’s needs.  Below, we’ll explore recommended cleanroom classifications for a few popular industries. For a full list of industries and their cleanrooms classifications, visit our cleanroom industries page. 

What cleanroom classification is best for aerospace applications?

Aerospace applications require control over mechanical, thermal, chemical, and electrical properties within the cleanroom. In most cases, their cleanrooms need to meet at least a Class 7 ISO classification. However, in highly sensitive applications like spacecraft hardware, fine electronic, and optical device development, a more stringent classification is necessary.

What cleanroom classification is best for manufacturing applications?

There are various types of manufacturing processes, all with different needs in terms of humidity, contamination, pressure, and temperature control. However, most manufacturing cleanrooms tend to be required to meet ISO Classes 7 or 8. 

What cleanroom classification is best for medical applications? 

There are a few sub-categories that fall under the broad category of medical cleanrooms, including medical research, medical device, and pharmaceutical cleanrooms. All of these cleanrooms have some of the most stringent classifications in order to protect the safety of operators and consumers. 

• Medical research: ISO Class 5-7
• Medical device: ISO Class 5-8
• Pharmaceutical: ISO Class 5

What cleanroom classification is best for semiconductor applications?

Contamination is a large source of production issues and product failures in semiconductors and microelectronics, so it’s critical that the cleanrooms they’re manufactured and packaged in are filtered appropriately. In most cases, semiconductor cleanrooms will hold ISO Class 4-6 requirements. 

3. How often should I test my cleanroom to see if it’s meeting classification requirements?

ISO requires that air pressure difference and airflow be tested every 12 months for all classifications. For ISO Classes 6-9, particle tests must also be performed every 12 months, but for ISO Classes 1-5, those particle tests must be performed every six months.  The following tests are recommended for all ISO Classes, every 24 months:

• Installed filter leakage
• Containment filter leakage
• Recovery
• Airflow visualization

4. How often do I need to have my cleanroom inspected?

That depends on your cleanroom classification. The more stringent the classification, the more regular the inspections. Inspections may coincide with compliance testing, so they could occur every 6-12 months, depending on your specific requirements. 

5. How does cleanroom classification affect my budget?

In general, the more stringent your cleanroom classification, the greater the cost. Strict classifications require more air, energy, advanced technology, and equipment, so their prices reflect that. For a more detailed breakdown of the costs, you can check out our blog, “How Does Cleanroom Classification Affect Your Cleanroom Budget?”

6. Can I redesign my cleanroom to fit a different classification?

Yes. Every facility’s needs change over time. A cleanroom from Angstrom Technology can change right along with them. All of our cleanrooms are “backward compatible,” meaning their size can expand or decrease and their fan filter units can be added or removed to keep up with any changes in cleanroom classification requirements.  Have any questions about your cleanroom classification and how to reach it? Contact the experts at Angstrom Technology! We’re happy to walk through your specific requirements and help design and build the best cleanroom for your facility and application.