The Cleanroom Commissioning Process: Explained

The Cleanroom Commissioning Process: Explained

Before a cleanroom is determined safe and viable for use, it typically will undergo a commissioning process.

What’s that? We’re here to fill you in. 

What Is Cleanroom Commissioning & Why Is It Important?

Cleanroom commissioning is the practice of verifying that a cleanroom functions in alignment with its design intent and the user’s operational requirements. It’s a systematic process that involves thorough evaluation and documentation of designs, systems, and procedures. 

Cleanroom commissioning is important because it helps to ensure a cleanroom operates as it’s intended and that all stakeholder expectations are met. It also ensures that components, machinery, and equipment within the cleanroom are approved by regulatory authorities and function appropriately. 

Who Is Responsible for Cleanroom Commissioning?

Depending on the extensivity of the commissioning needed, commissioning can start at different points during the cleanroom build process. In most cases, it’s largely the responsibility of the customer/user to complete the commissioning process. The cleanroom provider can help provide necessary documentation, but is not involved much more than that. 

However, a reputable cleanroom provider can help make the commissioning process successful by listening closely to customer specifications and delivering a high-quality solution that meets them. 

5 Stages of the Cleanroom Commissioning Process

The cleanroom commissioning process can vary tremendously. It can be abbreviated and include just a few stages or types of commissioning, or it can be very in-depth and take longer than the entire cleanroom project. It’s all set forth by the customer, their specific commissioning requirements, and documentation needed for their project. 

To give you a general sense of what the commissioning process could look like, we’ll outline five of the most common stages below. 

1. Design

One step of the commissioning process happens before a cleanroom is constructed: design. The design stage is important because this is where project expectations are set. 

Here are a few examples of expectations that are established during the design stage:

  • Vision and requirements for the cleanroom
  • Project and design goals
  • Measurable performance criteria
  • Budget
  • Schedule

From there, a cleanroom provider steps in to create the preliminary cleanroom designs, keeping applicable standards, codes, and regulations in mind. Once drawn, stakeholders are given multiple chances to review and approve designs before installation begins. 

2. Installation Verification

For modular cleanrooms with prefabricated components, installation verification is a two-part process. It begins offsite in the controlled environment where various modular components are engineered and manufactured. Here, the following tasks are performed: 

  • Verification that materials and equipment meet the original design intent
  • Verification that materials and equipment meet industry standards
  • Factory acceptance testing

Then, once the modular components are manufactured, they’re shipped to the site where they’ll be installed. Onsite, a few more tasks are performed: 

  • Site acceptance testing
  • Verification that equipment and system start-up meet protocol requirements
  • Verification of the test and balance report
  • Assembly of the cleanroom in accordance with established protocols
  • Creation of cleanroom maintenance manuals

3. Operational Verification

Operational verification is completed during three separate installation stages:

  • As-built – The cleanroom structure, mechanical systems, and electrical systems are built, but the cleanroom is empty. There are no machines, equipment, or pieces of furniture in it yet.
  • At-rest – All cleanroom components are in place, but nothing is running. No operators have started and run process systems.
  • Operational: All cleanroom components are in place and operating with operators. 


Throughout each of these sub-stages, tests are run to verify that cleanroom equipment and systems are operating in accordance with the design intent and sequence of operations. Staff also receive some training on how to operate certain machinery and systems.

4. Functional Verification

The functional verification stage is similar to the operational verification stage, but it focuses more on how the cleanroom and its systems function together. The following verifications are completed: 

  • Verification that all cleanroom equipment and systems operate per design intent and sequence of operations when integrated with each other
  • Verification that all cleanroom equipment and systems fail as intended in the user’s established “failure cascade”

5. Post-Occupancy

Once the cleanroom has completed the first four stages, it’s ready to be used for its intended purpose. But the commissioning work isn’t entirely done. After the cleanroom is up and running, a few more tasks need to be completed by the user. 

  • Ongoing tests and maintenance (usually in alternate seasons)
  • End of warranty inspections
  • End of warranty interviews with cleanroom operators
  • Creation of a recommissioning plan

10 Types of Cleanroom Commissioning

There are many different “types” of cleanroom commissioning — or in other words, many different tests and verifications that can happen during the commissioning process. Most of these tests and verifications are completed during the operational verification stage, but some are also completed again during the functional verification and post-occupancy stages. 

Some of these commissioning tests and verifications are: 

Again, the commissioning process often differs from one cleanroom to the next and one end user to the next. So while some cleanrooms may only undergo one or two of these tests, others may require much more.

Ready to Start Your Cleanroom Project? Contact Angstrom Technology. 

Commissioning is an important process that ensures quality control within your cleanroom. While you’re responsible for completing the commissioning process, we’ll do our part by manufacturing, building, and installing a high-quality, per-spec cleanroom that sets you up for success. To learn more about our turnkey cleanroom design-build services, contact us online

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GMP vs. cGMP Standards for Cleanrooms

GMP vs. cGMP Standards for Cleanrooms

Understanding cleanroom quality standards can be tricky. There are various systems, all of which have different themes, criteria, guidelines, and regulations.

One distinction that can be particularly challenging is the difference between GMP and cGMP standards. These standard sets sound similar, and they both work to ensure safety, quality, and repeatability in cleanroom environments. However, there are some key differences between the two. 


Let’s take a closer look at GMP vs. cGMP standards below. 

GMP vs. cGMP Standards for Cleanrooms

We’ll first note that GMP and cGMP standards may differ, but neither is “better” or “more effective” than the other. Often, the two systems work hand in hand to ensure a cleanroom is operating at peak performance and is in continuous compliance. In fact, the terms are frequently used interchangeably, even though they technically shouldn’t be. 

Let’s dive into some definitions. 

What Are GMP Standards for Cleanrooms?

GMP stands for “Good Manufacturing Practices.” It’s a quality management system used mainly by medical and pharmaceutical manufacturers. Its main goal is to “minimize the risks of microbiological, particulate, and pyrogen contamination during preparation and sterilization of medicines or medical devices.”

GMP standards focus largely on production and quality control. When applied specifically to cleanrooms, they address issues like:

  • Sanitation and cleanliness
  • Record keeping and documentation
  • Personnel qualification
  • Process validation
  • Equipment verification

In the United States, GMP standards are created and enforced by the Food and Drug Administration (FDA). In other countries, they’re created and enforced by other regulatory agencies. But while GMP standards may have minor differences across the globe, their main goal is the same. 

Learn more about GMP standards for cleanrooms in this blog post

What Are cGMP Standards for Cleanrooms?

cGMP stands for “Current Good Manufacturing Practices.” It’s a quality management system incredibly similar to GMP but with small yet important differences. 

With cGMP standards, every production stage is done using GMP guidelines but in the most “current” manner available. In a broad sense, “current” means a cleanroom and its operators must employ technologies and systems that are up to date and comply with GMP requirements. 

While cGMP standards have rules and regulations, they’re still somewhat flexible. They allow each manufacturer to choose which controls, systems, and technologies to use and how they want to implement them — as long as they remain compliant. This enables manufacturers to take innovative approaches and to constantly work on improving their processes. 

Learn more about cGMP standards in this article from the FDA.

Other Differences Between GMP and cGMP Standards for Cleanrooms

Besides the main distinction of “current,” there are a few other differences to note between GMP and cGMP standards for cleanrooms. The most pertinent ones to many manufacturers are cost and requirements for certification and testing. 

Cost

cGMP cleanrooms use new, innovative systems and technologies. This often makes their overall manufacturing, installation, and operating costs higher than those of GMP cleanrooms. 

Of course, cleanroom costs can vary depending on the overall project size and scope. This is just a common trend we’ve noticed and something to consider while you’re determining a project budget. For many manufacturers, the additional cost is well worth it for modern systems.

Certification & Testing

In most cases, cGMP cleanrooms are subject to a longer, more rigorous certification process before they’re ready for operation. They also tend to undergo more frequent, thorough tests year after year to verify ongoing compliance. This is to ensure that all controls, technologies, and systems are current, operable, and compliant. 

Questions? Contact Angstrom Technology.

Have more questions about cGMP and GMP standards and how they may fit into your cleanroom manufacturing, installation, and operation processes? Contact our team at Angstrom Technology. We have adequate training and an extensive portfolio of cGMP and GMP cleanroom projects under our belt, and we’d be happy to help design and build yours. 

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Cell and Gene Therapy Cleanroom FAQs

Cell and Gene Therapy Cleanroom FAQs

Cell and gene therapies have become more recognized as viable forms of treatment for serious, life-threatening illnesses. However, there’s still quite a bit of information to learn about them — including the controlled environments in which they’re tested, produced, and administered. 

If you’re hoping to learn more about cell and gene therapy cleanrooms, you’ve come to the right place. 

10 Frequently Asked Questions About Cell and Gene Therapy Cleanrooms

Below is a list of 10 of our most frequently asked questions about cell and gene therapy cleanrooms, along with their respective answers. 

1. What Is Cell and Gene Therapy?

Cell and gene therapies are two forms of regenerative medicine. They both have similar goals of lessening or curing a serious illness or disease, but there are some differences in how they’re implemented. 

  • Cell therapy involves injecting live, intact cells into a patient to lessen or cure their illness. These cells may be from the patient themself (autologous) or from a donor (allogeneic). 
  • Gene therapy involves injecting genetic material into a patient to change how a single protein or group of proteins is produced by the cell, ultimately lessening or curing their illness. 

Cell and gene therapies are gaining recognition in the field of medicine as safer, more personalized, less invasive, and potentially more effective ways to treat life-threatening diseases. 

2. What Are the Unique Risks Associated with Cell and Gene Therapy?

Cell and gene therapies are highly sensitive applications – more so than many other medical or medicinal functions. The many processes that go into testing, producing, and applying them can be manipulated easily if not completed with extreme caution.

Think of tasks like cellular and genetic engineering, growth, and purification. It’s critical that the results of those tasks are safe, effective, and reproducible to ensure treatment viability and patient safety. 

3. What Is a Cell and Gene Therapy Cleanroom?

Since cell and gene therapy applications are so high-risk, a controlled operating environment is necessary. A specially designed cleanroom can offer specialized control, cleanliness, equipment, and whatever else is needed to ensure treatment viability and patient safety. 

Cell and gene therapy cleanrooms have unique features compared to other types of cleanrooms. Many of these unique features are described in the answers to the questions below. 

4. What ISO Classification Do Cell and Gene Therapy Cleanrooms Require?

Typically, cell and gene therapy cleanrooms need to meet ISO Class 5-7 standards. However, this can vary depending on what particular task is being performed and how much environmental control it requires.

ISO classification can change from cleanroom to cleanroom, or from one of a cleanroom’s zones to another, or within a designated work chamber inside of the cleanroom. It can change to a level of less or more control. 

5. What Other Quality Standards Do Cell and Gene Therapy Cleanrooms Need to Meet?

ISO standards aren’t the only set of quality standards that cell and gene therapy cleanrooms require. In many cases, they need to comply with GMP (or cGMP) standards as well. 

Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (cGMP) are two quality management systems that are enforced by the U.S. Food and Drug Administration. They’re used by medical and pharmaceutical manufacturers to help minimize the chances of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medical devices and medicines. 

We have a few blogs that provide more specifics on GMP standards. You can check them out through these links: 

6. What Types of Special Equipment Do Cell and Gene Therapy Cleanrooms Require?

All cleanrooms require specialized equipment to meet the demands of their particular industry and application. Cell and gene therapy cleanrooms are no different. Some of their unique pieces of equipment include: 

  • Biosafety cabinets: enclosed workspaces that utilize laminar airflow to filter out contaminants and fumes. 
  • Incubators: devices that create the ideal environment for growing and maintaining cell and gene cultures. 
  • Refrigerators: devices used to store cell and gene cultures in the cold temperatures they need to survive for short periods of time. 
  • Freezers: devices used to store cell and gene cultures in the freezing temperatures they need to survive for extended periods of time. 
  • Centrifuges: machines that isolate strains of DNA or cells from body fluid. 

You can learn more about these types of equipment, as well as the risks that are associated with them, in this blog article

7. What Type of Cleanroom Is Best for Cell and Gene Therapy Applications?

Since cell and gene therapy cleanrooms need a lot of environmental control, a HardWall cleanroom solution is usually the best option. They offer a level of control against contamination, temperature, humidity, and more that other types of cleanrooms just aren’t designed for. 

8. What Type of Pressure Is Needed In Cell and Gene Therapy Cleanrooms?

It’s common for cell and gene therapy cleanrooms to be designed and installed as cell and gene therapy cleanroom suites. This means that the larger cleanroom facility contains multiple separate cleanroom zones. 

Within these zones, a cascading (or differential) pressure effect is employed. This means that the most stringent cleanroom zone has the highest level of pressure, and that the least stringent cleanroom zone has the lowest level of pressure. This pressure design is highly intentional, so that contaminant particles cannot flow into the cleanest, most controlled cleanroom zone.

9. Are HEPA or ULPA Filters Best for Cell and Gene Therapy Cleanrooms?

ULPA and HEPA filters are both effective at removing airborne particles from the cleanroom environment. However, ULPA filters provide the best filtration for most cell and gene therapy processes

ULPA filters are 99.999% efficient at removing particles 0.12μm or larger, while HEPA filters are 99.999% efficient at removing particles .3μm or larger. ULPA filters’ ability to filter out those smaller particles gives them the upper hand. However, some cell and gene therapy cleanrooms do just fine with a HEPA filter. 

10. Can You Provide an Example of a Cell and Gene Therapy Cleanroom Project?

Sure thing! In 2021, our partners at Connect 2 Cleanrooms designed, built, and installed a gorgeous cleanroom suite for RoslinCT — a leading cell therapy contract development and manufacturing organization in the UK. 

The cell and gene therapy cleanroom suite was installed within a two-story building and included 33 internal rooms. It now operates with high performance and control on a day-to-day basis to help healthcare professionals test and manufacture life-saving treatments. 

Some special features of the cleanroom include: 

  • ISO 5 classification (equivalent to EU GMP Grade B)
  • HEPA filtration with 79no. air changes per hour
  • Vaporized hydrogen peroxide (VHP) cabinets
  • Integrated medical gas systems
  • Cryostorage
  • Fire-rated active pass-through chambers

To learn more about this project and see photos and video of the finished result, visit this project page

Have More Questions? Contact Angstrom Technology

If you have more questions about cell and gene therapy cleanrooms, or you’re ready to design and install one of your own, don’t hesitate to reach out. We’d be happy to provide you with the answers or solutions you need. Give us a call at (888) 768-6900 or contact us online.

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5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms

5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms

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. 

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ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

In the past couple of years, cell and gene therapies have been recognized as viable forms of treatment for life-threatening conditions, leaving many healthcare professionals excited about putting more effort into researching, developing, and distributing them. But in order to do so, they need a highly controlled environment — otherwise their results aren’t guaranteed to be safe, effective, or repeatable. 

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. 

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What Is a Cell and Gene Therapy Cleanroom?

What Is a Cell and Gene Therapy Cleanroom?

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 that our partners at Connect 2 Cleanrooms built in 2021!

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.