Cascading Cleanroom Pressure: Explained

Cascading Cleanroom Pressure: Explained

You probably already know how important proper air filtration is in meeting your cleanroom’s ISO requirements. But what you may not realize is how important some other environmental factors are as well. Things like temperature, humidity, static, and pressure all need to be controlled in order to ensure a clean, hazard-free space for your sensitive operations. 

In this article, let’s take a closer look at airflow design and pressure — specifically cascading pressure. We’ll discuss what it is, why it matters, and when it’s needed. 

An Overview of Cleanroom Airflow Design & Pressure

If you have a baseline knowledge of cleanrooms, you may already know about airflow design and the two most common types of cleanroom pressure: positive pressure and negative pressure. If you don’t, we’ll break these concepts down for you: 

  • Positive pressure means the air pressure inside your cleanroom is greater than the pressure outside of it. Achieved by pumping filtered supply air into your cleanroom, this helps prevent harmful particles from entering and disturbing sensitive applications. The general rule of thumb here is that more supply air is coming into the cleanroom than is being exhausted out of it.  
  • Negative pressure means the air pressure inside your cleanroom is lower or less positive than the pressure outside of it. This prevents harmful particles from escaping or exiting to other critical spaces and damaging external environments. The general rule of thumb here is that more air is being exhausted out of the cleanroom than is being supplied and coming into it. You may think of it like a vacuum working to remove hazardous particles.   

Find more details on the difference between positive and negative cleanroom pressure here

What Is Cascading Pressure in a Cleanroom?

Most facilities and cleanroom suites require a specific airflow design, specifically known as cascading pressure. Cascading pressure means the most stringent cleanroom zone has the highest level of pressure, and the least stringent cleanroom zone has the lowest level of pressure. This is to ensure the flow of contamination is from clean to less-clean. In other words, there are pressure differentials in each of the zones within a cleanroom suite, based on how strict their cleanliness requirements are. 

Why Is Cascading Pressure Needed in a Cleanroom? 

Proper airflow design and pressurization is essential for facilities with cleanroom suites, or cleanrooms that have multiple rooms and/or zones within them, to control contamination. Typically, the tasks that are carried out within these zones require different levels of cleanliness and environmental control. Therefore, cascading pressure is needed to ensure air flows in a way that prevents particles from entering the cleaner zone, or most controlled space, in the suite. 

That said, airflow design is an important consideration for you to make before your cleanroom and associated technologies are installed. Talk with your cleanroom manufacturer to figure out the most effective, safe process flow for your applications and how best to monitor the airflow within the cleanroom. They’ll work with you to determine which zones should accommodate certain tasks, and how pressure should flow throughout them to best protect personnel and material processes. 

How to Monitor Cleanroom Airflow and Pressure in Between Zones

So you’ve designed your cleanroom suite to accommodate optimal airflow and pressure — but your work isn’t over yet. In order to ensure consistently controlled operations, you need to regularly measure and monitor airflow and pressure levels. 

Luckily, there are a few tools and technologies that make this process an easy one, including: 

  • Differential pressure gauges, which measure and visualize the difference between two pressure points within your cleanroom suite. 
    • Magnehelic or analog gauges, which have a needle pointer or dial that senses the differential in air pressure and responds to the change in pressure between the adjacent spaces. The pressure reading is displayed. 
    • Digital pressure gauge, which senses the differential in air pressure and responds to the change in pressure between the adjacent spaces, and is then converted to an electronic signal, shown using a digital display.
  • Distributed sensor modules (DSMs), which are network-accessible modules used to monitor room differential pressure, and in some cases temperature and humidity as well. The output of the sensor is an analog signal that can be fed to a console or interface card for monitoring and control. One great benefit of these modules is that they can be connected to your building management system (BMS), so measuring and monitoring cleanroom airflow and pressure is in one cohesive system where all the readings are in one place.

Need Help With Your Next Cleanroom Project? Contact Us

If you have questions related to pressure or any other cleanroom-related topic, don’t hesitate to contact us at Angstrom Technology. Our team is full of skilled, friendly experts who are happy to provide the answers you need. And as an industry leader in cleanroom design and installation, we’re able to tackle whatever specifications your cleanroom project may require. 

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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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SoftWall Cleanroom Features

SoftWall Cleanroom Features

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.

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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. 

Your Guide to Radiopharmaceutical Cleanroom Design

Your Guide to Radiopharmaceutical Cleanroom Design

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. 

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