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

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. 


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. 

Post-and-Panel vs. Seamless Cleanroom Wall Systems

Post-and-Panel vs. Seamless Cleanroom Wall Systems

The materials you use to build your cleanroom have a lasting impact on its cleanliness, performance, durability, and appearance. Arguably the most important of these materials is the cleanroom wall system you choose. 

Let’s take a look at two of the most common types of cleanroom wall systems: post-and-panel and seamless. 

Post-and-Panel vs. Seamless Wall Systems: What’s the Difference?

First, some definitions. Learn more about what post-and-panel and seamless wall systems are, and how they differ below. 

What Is a Post-and-Panel Cleanroom Wall System?

A post-and-panel cleanroom wall system utilizes a series of non-progressive posts and panels that are joined together to create a modular enclosure. The posts and panels are “stitched” together with a corrugated roof deck that keeps them in place. 

The end result? A modular enclosure that’s self-supporting, reconfigurable, and isolated from its surrounding environment. It stands alone and is separate from the existing building structure. 

What Is a Seamless Cleanroom Wall System?

A seamless cleanroom wall system utilizes studless, flush wall or liner panels to create a modular enclosure. These wall panels can be either progressive or non-progressive but are tightly sealed so that no seams are exposed. They also have coving (a curved covering that connects a wall to a ceiling) on both horizontal and vertical intersections. 

A seamless cleanroom wall system can be tied into steel stud walls and/or the existing building structure that surrounds it. It also typically features a flush, walkable ceiling. Its seamless design allows for durable performance and sleek aesthetic appeal for the most stringent applications. 

Pros & Cons of Post-and-Panel Cleanroom Wall Systems

Now let’s take a look at some of the advantages and disadvantages of these cleanroom wall systems, specifically highlighting distinguishing factors between each type. We’ll start with post-and-panel. 

The main advantages of post-and-panel cleanroom wall systems are: 

  • They can be reconfigured easily. Due to their non-progressive nature, post-and-panel wall systems are the easiest type to reconfigure. The-two piece stud post allows removal and replacement of a wall panel without disturbing adjacent panels. They also accomodate quick and easy vertical installation of electrical, data, and communication lines in the raceways, which are accessible from the removable cover plate. If your facility is expecting growth or changes in the future, this is an important benefit to consider. 
  • They’re self-supporting. Post-and-panel wall systems can stand alone. The structural-grade, extruded aluminum acts as a structural column on spaces with long clear spans or load bearing roofs. The stud system will accommodate steel tube inserts for additional load bearing capability. They don’t need to be integrated into an existing building structure, giving you a bit more versatility with placement and layout. 

The main disadvantages of post-and-panel cleanroom wall systems are: 

  • They’re harder to clean. Because they’re not fully seamless (the panels will fit within studs creating an ⅛” protrussion or less) and have no coving integrated into their system, post-and-panel wall systems can be more difficult to clean. There are more seams and crevices where particles can accumulate. 
  • They’re not FM-approved. Post-and-panel wall systems are Class A non-combustible, but they’re not FM-approved. This may be a deal breaker for certain applications, depending on industry-specific requirements. 

Pros & Cons of Seamless Cleanroom Wall Systems

Now for some advantages and disadvantages of seamless cleanroom wall systems — which are basically the opposite of what we mentioned about their post-and-panel counterparts. 

To start, the main advantages of seamless cleanroom wall systems are: 

  • They’re easy to clean. Seamless wall systems have tight, chemically cold-welded uPVC seams and coves so there are no crevices for contaminants to build up in or air leakage. This makes them much easier to clean, wash down, and fumigate. For higher ISO classifications with stringent cleaning requirements, this is the best option.
  • They feature a floating flush ceiling. Their floating flush ceiling offers the same fine line seams and finishes as the modular wall system. The flush ceiling platform utilizes 5’ x 10’ ceiling panels and 5’ x 10’ hanger spacing, allowing the installation of FFUs and lights without changing the ceiling panel orientation. Interior wall panels are attached to the bottom surface of the ceiling panels and wall/ceiling covings can be run at any location making it integral to the cleanroom system. The walkable ceiling is capable of supporting a wide variety of mechanical systems and accommodating components and small equipment.
  • They’re FM-approved. Seamless wall systems are both Class A non-combustible and FM-approved, meaning they offer the considerable level of fire resistance that some cleanroom applications require. 

The main disadvantages of seamless cleanroom wall panels are:

  • They’re not as easy to reconfigure. While it’s definitely not an impossible task, reconfiguring a seamless cleanroom is a bit more difficult. This is especially true if it’s built with progressive wall panels where replacement is done through the use of rotating splines.
  • They can’t stand alone. Seamless cleanroom wall systems aren’t self-supporting. They must tie into the existing building structure, or you’ll have to build a steel superstructure for support.
  • They’re a bit more expensive. Since the system isn’t structurally sound on its own and must be supported by a steel superstructure or existing building, seamless cleanroom wall systems are generally the more costly option.  

What Type of Wall System Is Best for My Cleanroom?

Both post-and-panel and seamless cleanroom wall systems are great options that can meet varying specifications you need them to, so there’s not really a “wrong” answer to this question. A better way of looking at it is there might be one option that’s better for you than the other. That can vary for you based on a few factors, including:

Our recommendation is that before deciding anything, you should connect with a cleanroom specialist. They’ll be able to listen to your unique needs and recommend a solution that will work best for you. 

Start Your Cleanroom Design & Build Project with Angstrom Technology

Thinking about installing a new cleanroom in your facility? We can help! At Angstrom Technology, our cleanroom specialists have extensive experience designing, building, and installing cleanrooms with high-quality materials. 

From deciding which type of cleanroom wall system is best for your application to ensuring you have enough air filters and handling units to maintain a controlled environment, we’ll help you work through the details of your project. Then we’ll make your vision come to life! 

To get started working with us, give us a call at (888) 768-6900 or contact us online.

Dedicated vs. Integrated Cleanroom HVAC Design

Dedicated vs. Integrated Cleanroom HVAC Design

Environmental control is the staple of effective cleanroom design and performance. In order to ensure safe and controlled operations can take place, airborne particles of a certain size must be caught and removed from the cleanroom environment. 

However, there’s more to the equation than just air filtration. Regulating temperature and humidity within your cleanroom is also an important factor in maintaining a high level of environmental control and to protect customer products. A well-equipped and strategically configured HVAC system can get you there.

What Does an HVAC System Do?

HVAC systems are air handling units engineered for precise control over temperature and humidity within an enclosed space. They complement filtration systems like HEPA and ULPA filters which sit in your cleanroom’s ceiling grid. 

When it comes to choosing an HVAC system for your cleanroom, you have two options: dedicated or integrated. Below, we’ll discuss what each of these options means so you can make an informed decision about what will help your cleanroom reach peak performance. 

Dedicated vs. Integrated Cleanroom HVAC Design: What’s the Difference?

So what are dedicated and integrated HVAC systems? Their definitions have to do with how each one is designed and implemented within the cleanroom environment, and possibly within the larger facility as a whole. 

  • Dedicated cleanroom HVAC design is when an HVAC system is designed specifically for the cleanroom and utilizes its own system. It operates independently from the rest of your facility’s existing HVAC system.
  • Integrated cleanroom HVAC design is when the facility’s existing HVAC system is used to service, tie into, and maintain the cleanroom. It operates in utilizing the larger facility’s system.

After reading and understanding those descriptions, you may get a sense of the advantages and disadvantages related to each design choice. In the following sections, we break that down a little more clearly.  

Pros & Cons of Dedicated Cleanroom HVAC System

Dedicated cleanroom HVAC system is a smart choice for many facilities. In fact, it’s usually the only configuration that can meet a cleanroom’s specifications. In terms of design, air changes per hour, heat loads, air filtration, and environmental control over temperature and humidity, this is the choice that can meet the most stringent HVAC requirements

A dedicated cleanroom HVAC system can also help a facility balance the load put on their various operational systems. Since it’s independent of the rest of the building’s HVAC system, it carries its own load and doesn’t take anything away or starve other external spaces. This is a big deal when you think about how much energy and air cleanroom HVAC systems circulate on a daily basis. 

A few disadvantages here? 

Dedicated cleanroom HVAC systems can cost more and require a more involved process upfront. Since an entirely new system is being installed, site details, existing facility drawings,  design, coordination with other engineers, and installation time is usually necessary. 

But after installing an HVAC system that’s reliable, meets the required specifications, and performs well, most facility managers find that the upfront cost was well worth it — making the dedicated HVAC system a more cost-effective choice in the long run. 

Pros & Cons of Integrated Cleanroom HVAC System

When you look at an integrated cleanroom HVAC system, the advantages and disadvantages are basically the opposite of those described above. 

The biggest benefit of integrated cleanroom HVAC system is that it requires less design and installation time because you are tying into the existing facility’s system. Because of this, it may cost less upfront. However, that lower upfront cost often comes with a lower-performing system or cleanroom. 

Since integrated cleanroom HVAC systems are incorporated into buildings’ existing HVAC systems, they use the same supply air as the rest of the building, which is typically not designed for cleanroom applications. 

For cleanrooms that need a high level of environmental control, need to turn the air over a significant amount of times per hour, and need to protect the safety of the product, this can be detrimental. Air from other areas of the building is designed for creature comfort of their employees, so it’s controlled differently than a cleanroom. Merging the two operations together creates unpleasant environments for one of the two parties. 

Which Type of Cleanroom HVAC System Is Right for My Facility?

No matter your cleanroom’s size or application, a dedicated cleanroom HVAC system is the most effective choice. It’s more capable of meeting requirements related to filtration, temperature, humidity, and more — ultimately providing you will a controlled, high-functioning, cost-effective space. 

If you’re still unsure about how this type of cleanroom HVAC design could fit into your facility, get in touch with a trusted cleanroom manufacturer or technician. They’ll be able to listen to your concerns and provide you with recommendations that are customized to fit your needs. 

Ready to Start the Cleanroom Design Process? Contact our Experts

Your cleanroom’s HVAC system is essential to the safety and efficiency of your operations. If you’re looking for a cleanroom manufacturer that can deliver a well-designed, high-performance solution, contact Angstrom Technology for more information or request a quote today. 

Our cleanroom design and engineering specialists have experience working with customers in all kinds of industries, achieving great results time and time again. We’d love to work with you as well!

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.