Dedicated vs. Integrated Cleanroom HVAC Design

Dedicated vs. Integrated Cleanroom HVAC Design

by | Aug 10, 2022 | Cleanroom 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!

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Cell and Gene Therapy Cleanroom FAQs

Cell and Gene Therapy Cleanroom FAQs

by | Aug 4, 2022 | Cleanrooms

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 UK division – Connect 2 Cleanrooms – designed, built, and installed a 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. 

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What Industries Require GMP Cleanrooms?

What Industries Require GMP Cleanrooms?

by | Jul 26, 2022 | Cleanroom Standards

If you’ve heard about GMP cleanrooms (if you haven’t, head over to this blog), you might be wondering whether or not you actually need one. Below, we’ll walk through some of the most common industries that require GMP-compliant cleanrooms. 

What Is a GMP Cleanroom?

GMP stands for Good Manufacturing Practices, which are quality management standards most commonly used by medical and pharmaceutical manufacturers. Among other things, they help to ensure a controlled cleanroom environment that reduces the risk of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. In the United States, GMP standards are established and enforced by the Food & Drug Administration (FDA). 

Therefore, a GMP cleanroom is a cleanroom that has been assessed and confirmed to comply with applicable GMP standards. 

It’s important to mention cGMP here as well. If you’ve done any research regarding GMP standards, you might have seen “cGMP standards” pop up and wondered if they’re the same. They’re similar, but not quite the same. Note the differences here: 

  • GMP focuses on how your cleanroom is designed, built, and operates in a way that results in safe and effective products. 
  • cGMP focuses on how you use technologies and systems that are up-to-date and comply with GMP standards. 

5 Industries That Require GMP Cleanrooms & Why

Now let’s take a closer look at a few industries that require GMP-compliant cleanrooms. While these aren’t the only industries or applications that need GMP cleanrooms, they’re some of the most common that we work with here at Angstrom Technology. 

1. Pharmaceutical

Pharmaceutical cleanrooms are designed to house any application that involves medicines or supplements. This includes tasks like research, testing, compounding, packaging, and more. 

The pharmaceutical industry calls for GMP cleanrooms in order to protect patient safety and ensure accurate, effective, and repeatable results. Without adherence to GMP standards, pharmaceutical cleanrooms could produce medicines that are ineffective, or even worse, harmful to human health. 

In addition to GMP standards, some pharmaceutical cleanrooms that deal with compounding must also comply with another set of quality management standards: USP standards. Learn more about USP standards here. 

Curious to see what a finished, GMP-compliant pharmaceutical cleanroom project looks like? Check out this one completed by our team at Angstrom Technology!

2. Radiopharmaceutical

Radiopharmaceuticals are a subcategory of pharmaceuticals that contain radioactive isotopes. In the past, they’ve been widely used as diagnostic agents to detect a range of health issues. Recently, they’re gaining recognition as a viable form of treatment for serious diseases like cancer. 

Although they sound similar to traditional pharmaceutical cleanrooms, radiopharmaceutical cleanrooms require specific design considerations. This is because exposure to radioactive isotopes within the drugs can harm the health of cleanroom operators. Therefore, there are two reasons radiopharmaceutical cleanrooms must comply with GMP standards: to ensure accurate, effective, and repeatable results, and to ensure cleanroom operator safety. 

Radiopharmaceutical cleanrooms must also comply with USP standards, specifically USP General Chapter 825. Explore USP General Chapter 825 guidelines here. 

To see an example of a GMP-compliant radiopharmaceutical cleanroom completed by Angstrom Technology, click here. 

3. Cell & Gene Therapy

Cell and gene therapy are two forms of regenerative medicine. In cell therapy, live and intact cells are injected into a patient to treat or cure the disease. In gene therapy, altered genetic material is injected into a patient to change how a single protein (or group of proteins) is produced by a cell, ultimately treating or curing the disease. 

That said, cell and gene therapy cleanrooms house some extremely sensitive processes, such as cellular and genetic engineering, growth, and purification. GMP compliance is necessary in order to ensure product efficacy and patient safety. 

Explore a GMP-compliant cell and gene therapy cleanroom project, completed by our partners at Connect 2 Cleanrooms, here. 

4. Medical Device Manufacturing

Medical device cleanrooms are designed to house applications in which medical devices like injectables, surgical supplies, and imaging equipment are manufactured. Many people understand that consumables like medicine must be regulated, but what they don’t realize is that the devices used to help consume them must also be regulated. They come in contact with tissues and membranes, and can therefore affect patient health. 

In order to protect patient health and safety, GMP compliance is required for any medical device cleanroom. 

Angstrom Technology recently completed this GMP-compliant medical device manufacturing cleanroom project. Check it out!

5. Food & Beverage

Last but not least, any cleanroom involving food or beverage products requires GMP compliance. This could include activities like testing, manufacturing, packaging, or more. 

Since food and beverage products are consumed, their production processes must be regulated by GMP standards to ensure consumer safety. 

Start Your GMP Cleanroom Project With Angstrom Technology

GMP cleanrooms are built to ensure that health, medicinal, and food products are consistently safe for consumption. If your cleanroom application is required to meet GMP standards, contact our experts at Angstrom Technology. We’d be happy to design a cleanroom that meets applicable requirements and help you navigate the GMP qualification and validation processes.

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7 Steps to Modular Cleanroom Installation

7 Steps to Modular Cleanroom Installation

by | Jul 20, 2022 | Cleanroom Installation

At Angstrom Technology, modular cleanrooms are our bread and butter. We love their pre-engineered, high-quality components and their speedy installation processes — and our customers do too! 

If you’re considering a modular approach to your next cleanroom project, you might have a few questions about the installation process. We have answers!

What Is a Modular Cleanroom?

First, let’s recap exactly what a modular cleanroom is. 

A modular cleanroom consists of non-progressive, prefabricated components that are manufactured offsite and then assembled onsite. Modular cleanrooms can be installed within an existing facility as a freestanding structure or supported by the existing building’s structure if need be. 

What Are the Benefits of Modular Cleanrooms?

Modular cleanrooms offer the same benefits as traditionally constructed cleanrooms, and then some. They are: 

  • Versatile. Non-progressive in nature, modular cleanrooms can be easily reconfigured, expanded, or relocated to meet the changing needs of your facility. 
  • Convenient. Modular cleanrooms result in less construction mess and minimal interruption to your facility’s surrounding operations. 
  • Environmentally friendly. Modular cleanrooms are not only made from recycled materials but they produce less construction waste and are also built for durable and versatile long-term use. 
  • Affordable. Due to the nature of the prefabricated components, there is reduced labor costs which make modular cleanrooms more affordable than traditional ones. Cost varies based on the size and scope of your project, however. 
  • Ready to install. Most pertinent to this article, prefabricated modular cleanroom components allow for quick and simple installation processes. 

The 7 Steps to Modular Cleanroom Installation

Arguably the biggest benefit of installing a modular is just that: the installation. The modular cleanroom installation process is fast and uniformed. Since components are pre-engineered and manufactured in a controlled environment offsite, they’re ready to install as soon as they’re delivered. In some cases, this can take just a few days!

Here’s an overview of what each step of the modular cleanroom installation process looks like, from design drafts to finishing touches:

1. Create Designs

A great cleanroom starts with a great design. To start the project off, a lot of time is spent in the design phase, ensuring that all aspects are feasible and highly detailed. This sets the scene for a successful, error-free manufacturing process. 

2. Manufacture Components Offsite

Next up is engineering and manufacturing. In a controlled facility offsite, various cleanroom components are manufactured according to the design specifications listed. Detailed, high-quality work here helps ensure that no problems arise during the installation process. 

3. Deliver Components to the Construction Site

Once manufacturing is completed, each component of the modular cleanroom is delivered to be assembled onsite. 

4. Build!

This is where the true modular cleanroom “installation” process begins. Expert installers work to assemble each component of the modular cleanroom until the final structure is complete. This stage can vary from a few days to several weeks, but will depend on the size of your project.

5. Connect Utilities & Services

In order to get the cleanroom running optimally, all ancillary services need to be connected and properly installed. This includes HVAC, electrical, plumbing, and more. Close and frequent coordination throughout the modular cleanroom installation process helps to ensure all systems are up and running smoothly.

6. Implement Additional Equipment

Once the modular cleanroom structure is standing, any additional equipment is incorporated. Many cleanroom industries and applications require specialized machines or technologies to complete everyday tasks. Aside from the usual air filtration systems, this could include anything from workstations to pass-through chambers to conveyor belts. 

7. Complete Qualification & Validation Process (If Necessary)

Most cleanroom projects require some sort of certification, qualification, or validation. The type needed depends on what standards and classifications are required for the industry but could be one or more from this list: GMP, cGMP, ISO, ASTM, or USP. These approval processes are there to confirm the cleanroom is safe, effective, and efficient for the application it’s expected to host. 

Have more questions regarding modular cleanrooms? Check out our previous post, Modular Cleanroom FAQs. 

Want to Install a Modular Cleanroom? Trust Our Experts

If you’re looking to install a cleanroom as quickly and efficiently as possible, modular is the way to go — and Angstrom Technology is the place to go! From full-size turnkey cleanroom projects to customized expansions, our experts have the experience needed to design, build, and install a modular cleanroom that works for you. To get started, give us a call at (616) 866-2400 or request a quote online.

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What’s the Best Type of Flooring for Pharmaceutical Cleanrooms?

What’s the Best Type of Flooring for Pharmaceutical Cleanrooms?

by | Jul 14, 2022 | Uncategorized

When you think about a pharmaceutical cleanroom, the floor probably isn’t the first thing that comes to mind. In fact, it may even be the last. 

For many facilities, floors are the most forgotten component of cleanroom design. However, the type of flooring you choose for a pharmaceutical cleanroom has a huge impact on overall contamination control and performance. This is of utmost importance when you’re working with consumables like medicines and supplements that need to be safe, effective, and repeatable. 

4 Common Types of Cleanroom Flooring

Let’s take a look at four of your cleanroom flooring options. Then, we’ll give some insight on which may be best suited for pharmaceutical applications. 

1. Heat-Welded Vinyl Cleanroom Flooring

Heat-welded vinyl is a seamless pharmaceutical flooring solution. It has no crevices for contaminants to accumulate in and expose your cleanroom to. It also provides the option to implement a cove base up the wall (typically 3 – 6”), which eliminates 90° corners where floors and walls meet and further prevents contamination to settle and be difficult to clean. 

Heat-welded vinyl flooring is also easy to clean and can withstand harsh cleaning agents, lessening the burden of rigorous pharmaceutical cleanroom cleaning protocols. It’s relatively economical as well. 

One downside of heat-welded vinyl flooring is that it can wear out quickly when exposed to heavy weights. But if you’re working in a pharmaceutical cleanroom with minimal heavyweight equipment, it’s a great overall choice. 

2. Epoxy-Coated Cleanroom Flooring

Epoxy is a coating placed over a solid concrete substrate, usually in a three-part process. First, the flooring must be prepped with a combination of grinding, scarifying, shot blast, and filling in larger holes or cracks where moisture can seep in. A rough surface is necessary for the epoxy to adhere to. This coating allows for a seamless surface with no crevices for contaminants to build up and harm the integrity of your cleanroom. Similar to heat-welded vinyl, there’s also an opportunity to install a cover base that eliminates 90° corners where floors and walls meet. 

Epoxy-coated cleanroom floors are dense with low porosity, which makes them easy to clean and durable, even when exposed to heavy weight and high traffic. They don’t shed any particles, and you can even opt to add anti-static features. 

Epoxy-coated floors also come in a variety of colors, so you can choose which best suits your pharmaceutical cleanroom. 

3. Polyurethane-Coated Cleanroom Flooring

Polyurethane is another coating placed over a solid concrete substrate, usually in a one- or two-part process. It exhibits a glossy or satin finish that maintains its shine even when exposed to heavy weight and high traffic. This light-reflecting property is great for extra illumination within the cleanroom environment. 

Polyurethane-coated floors are also resistant to harsh chemicals and substances, which make them highly effective in industrial manufacturing cleanroom applications. 

4. Interlocking Vinyl Tile Cleanroom Flooring

Interlocking vinyl tiles are newer to the cleanroom flooring world. They fit together like puzzle pieces to create a seamless floor — all of which makes for quick and easy installation, even above existing, worn subfloors. 

Most interlocking vinyl tiles are easy to clean and durable enough for heavy traffic. Some can also be treated for anti-static performance. There is also a wide range of colors and finishes to choose from, so you can ensure your cleanroom looks as great as it operates. 

What’s the Best Type of Flooring for Pharmaceutical Cleanrooms?

There’s not a “one-size-fits-all” answer to this question. The best type of flooring for your pharmaceutical cleanroom greatly depends on the specifics of your facility and application. 

However, we can offer some general guidelines in relation to pharmaceutical cleanroom needs. Most importantly, pharmaceutical cleanrooms need to be cleaned often, so it’s important to have a floor that can withstand frequent cleaning and harsh chemicals. Also, in most cases, pharmaceutical cleanrooms are exposed to quite a bit of traffic. You need a flooring option that operators can walk freely on, without having to worry about particle shedding. 

With all of this information in mind, we can provide the general recommendation that either heat-welded vinyl or epoxy-coated floors would be best for your pharmaceutical cleanroom. However, it’s important to remember that this recommendation doesn’t ring true for every pharmaceutical cleanroom, so it’s best to consult with a trusted cleanroom manufacturer to confirm. 

Design Your Pharmaceutical Cleanroom With Angstrom Technology

Need help deciding on the right type of flooring for your pharmaceutical cleanroom, or any other design element? Don’t hesitate to reach out to our team at Angstrom Technology. As experts in cleanroom design and installation, we’re happy to recommend the components and materials that will be most effective for your application. Give us a call at (888) 768-6900 or contact us online today. 

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