ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms

by | Apr 11, 2022 | 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. 

cleanroom-classification-quiz-cta
SoftWall Cleanroom Features

SoftWall Cleanroom Features

by | Mar 23, 2022 | Softwall Cleanrooms

There are three common types of cleanrooms: HardWall, SoftWall, and RigidWall. The differences behind each of them lie in their materials, construction, layout, level of environmental control, and more. While all of them are great cleanroom options, one may be better suited for your cleanroom application and classification than the others. 

In this article, let’s take a closer look at SoftWall cleanrooms. We’ll discuss what they are, what special features and capabilities they provide, and what benefits they could bring to your cleanroom application. 

What Are SoftWall Cleanrooms?

SoftWall cleanrooms are the most cost effective type of cleanroom. Known for their affordability and versatility, they’re minimalist, easy to install cleanrooms that can meet a variety of ISO standards. Because of these characteristics, they make great cleanroom options for industries and applications that have minimal space within their facility, are under a quick time frame to get the project completed, and don’t require strict environmental requirements such as: plastics manufacturing, automotive, and some medical cleanroom applications. 

SoftWall Cleanroom Features

Depending on the specific application, every SoftWall cleanroom is designed and built differently. However, they all have some of the same basic features, which are listed in the three sections below: 

SoftWall Cleanroom Materials

In the most basic sense, SoftWall cleanrooms consist of an extruded aluminum ceiling system, legs, and clear curtains around the perimeter. Additional specifications include:

  • Ceiling System – A SoftWall cleanroom’s ceiling system consists of a detailed network full of extruded aluminum framework, fan filter units (FFUs), lights, and cleanroom ceiling tiles. 
  • Framing – SoftWall cleanroom framing is made of a durable, extruded aluminum, which is finished with white powder baked enamel or clear anodized. 
  • Curtains – SoftWall cleanroom curtains are made of 40, 60, or 80 mil acrylic, PVC, polycarbonate, anti-static PVC, or polysim. They’re typically clear curtains, but depending on your application you may require light wavelength control and UV absorption. Curtains are mechanically fastened to the structure in an extruded track around the perimeter of the room.
  • Entrances – SoftWall cleanrooms are compatible with strip curtain entrances, which can either be stationary or on a sliding track. 

SoftWall Cleanroom Sizes

SoftWall cleanrooms are available in standard sizes that come in 2’ x 4’ increments. However, many cleanroom manufacturers will allow you to request a custom size if needed. 

SoftWall Cleanroom Standards

SoftWall cleanrooms are able to meet most ISO standards. However, they don’t provide as much environmental control as their HardWall and RigidWall counterparts. 

Benefits of SoftWall Cleanrooms

So, what exactly makes SoftWall cleanrooms such a popular choice? Here are some of the most common reasons why our customers at Angstrom Technology enjoy them: 

Unmatched Affordability

Due to their simple, minimal design, SoftWall cleanrooms are typically the most affordable type of cleanroom. However, it’s important to remember that if your application requires the high level of control that only HardWall or RigidWall cleanrooms can provide, you’re better off making that higher upfront investment than trying to pinch pennies and purchase an ineffective solution. 

Extreme Reconfigurability

Also due to their simple, versatile design, SoftWall cleanrooms are more portable. They’re easy to move and modify, and they’re even able to fit into tight spaces other cleanroom types won’t because of their small footprint. This extreme reconfigurability results in their ability to provide a long-lasting investment. 

Exceptional Versatility

Although SoftWall cleanrooms all have the same basic features, they can be built to meet your specifications. Whatever filtration systems, specialized equipment, or workspaces you need, they’re all able to be installed and accommodated in a SoftWall cleanroom. 

Quick & Easy Installation

With minimal required materials and a relatively simple design, SoftWall cleanrooms can typically be installed within just a few days. Of course, this timeline depends on your project’s size and scope — but, overall, they’re the quickest type of modular cleanroom to build and install. 

The combination of low-cost and high versatility makes SoftWall cleanrooms an appealing option for any growing business. Think a SoftWall cleanroom might be right for your application? Angstrom Technology can help! Our team has extensive experience designing, installing, and servicing all types of cleanrooms, and we’re ready to aid in the development of yours. To get started, give us a call or contact us online today.

cleanroom-classification-quiz-cta
What Is a Cell and Gene Therapy Cleanroom?

What Is a Cell and Gene Therapy Cleanroom?

by | Mar 21, 2022 | Cleanrooms

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. 

Your Guide to Radiopharmaceutical Cleanroom Design

Your Guide to Radiopharmaceutical Cleanroom Design

by | Mar 14, 2022 | Pharmaceutical Cleanrooms

Used to diagnose and treat life-threatening diseases, radiopharmaceuticals make up a relatively new sector in the field of medicine. And, due to their radioactive nature, they need to be managed and manufactured a bit differently than traditional pharmaceuticals. This is why it’s critical (and required by public health standards and laws) that radiopharmaceutical drug production is done in a highly controlled cleanroom that’s equipped to store, prepare, fill, and pack radioactive materials safely. 

Below, we’ve created a guide to radiopharmaceutical cleanroom design — giving you an inside look at all the design considerations that go into creating one of these controlled, cutting-edge spaces. 

6 Key Radiopharmaceutical Cleanroom Design Components

Of course, all radiopharmaceutical cleanroom designs are a bit different. It depends on a variety of factors, such as the particular application happening within them, the space in which they’re built, etc. However, many of them have the same basic components and design considerations. We’ve listed six fairly common ones below:

1. Radiopharmaceutical Cleanroom Classification

The main component of any cleanroom is its ISO classification, and radiopharmaceutical cleanrooms are no different. In most cases, radiopharmaceutical cleanrooms are required to meet ISO Class 7-8 standards. However, they may also have designated areas or chambers that must meet even more stringent standards, like ISO Class 6 or higher. 

2. Radiopharmaceutical Cleanroom Type

In order to meet high levels of cleanliness and environmental control, radiopharmaceutical cleanrooms are most often built as HardWall structures. This type of cleanroom has the most control over contamination, temperature, humidity, pressure, and static. 

3. Radiopharmaceutical Cleanroom Size

Cleanroom size can greatly vary from one radiopharmaceutical cleanroom project to another. But in terms of effective radiopharmaceutical cleanroom design, the most important thing to consider is allowing enough space for all necessary equipment, as well as personnel and product flow. 

Radiopharmaceutical cleanrooms generally host multiple pieces of equipment, the most common being hot cells. Hot cells are shielded containment and operating chambers that protect cleanroom personnel from radioactive substances within the medicines. 

They’re usually around 4 feet wide and 12 feet tall, so allocating space for a few of them can be challenging — especially when you also need to accommodate space for efficient workflow surrounding them. That’s where a radiopharmaceutical cleanroom designer’s expertise really comes in handy. 

4. Radiopharmaceutical Cleanroom Pressure

Radiopharmaceutical cleanroom design can also get a bit complicated when it comes to pressurization and confirming there is a cascading effect; where the most stringent or highest classification cleanroom should have the highest positive pressure. When a facility has multiple cleanroom areas (which is typical in radiopharmaceutical applications), it’s critical to design pressure and air to flow a certain way so that particles and contaminants are unable to enter the most controlled space in the facility. 

In addition, radiopharmaceutical cleanrooms typically have fume hoods that are operating at ISO 5 and need to be exhausted to the exterior or out of the cleanroom suite.

5. Radiopharmaceutical Cleanroom Temperature & Humidity

In radiopharmaceutical cleanrooms, temperature and humidity are both important factors to keep under strict control and monitoring. Radiopharmaceuticals cannot be kept under extreme temperatures or humidity levels, otherwise they will become less effective, run the risk of microbial growth, or be unsafe for human consumption. Therefore, environmental control and monitoring systems are built into many radiopharmaceutical cleanrooms’ designs. 

6. Additional Equipment & Technologies for Radiopharmaceutical Cleanrooms

Finally, radiopharmaceutical cleanroom operations call for a variety of unique pieces of equipment and technology. These devices could include (but aren’t limited to) some of the following:

  • Hot cells
  • Isolators
  • Elaborate casework
  • Fume hoods
  • Environmental control and monitoring systems (which can be connected to the building management system, or BMS)
  • Biosafety cabinets
  • Sterile work tables and surfaces
  • Cyclotron storage
  • Gowning rooms

Hoping to design and install a radiopharmaceutical cleanroom in your facility? Let us know! At Angstrom Technology, our team can help you build a modular cleanroom that’s perfect for your project needs. To get started working with us, contact us online. 

Interested in learning more about one of our latest radiopharmaceutical cleanroom projects at Angstrom? Check out our Advanced Radiopharmaceuticals Cleanroom Project page or our recent case study. 

cleanroom-classification-quiz-cta
What to Expect from the Cleanroom Design Process

What to Expect from the Cleanroom Design Process

by | Mar 7, 2022 | Cleanroom Design

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

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

10 Things to Consider During the Cleanroom Design Process

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

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

1. Cleanroom Classification

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

2. Cleanroom Size

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

3. Cleanroom Location

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

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

4. Temperature & Humidity

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

5. Static

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

6. Lighting Levels & Color

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

7. Material & Personnel Flow

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

8. Wall Systems & Flooring Material

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

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

9. Fire Protection & Rating

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

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

10. Additional Equipment & Furniture

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

Why Work with a Team of Cleanroom Design Experts?

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

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

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

Choose Angstrom Technology For Your Cleanroom Design

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

cleanroom-classification-quiz-cta