For some industries, simple stainless steel tables make for adequate cleanroom workstations. Cell and gene therapy isn’t one of them. Due to the sensitivity of their materials and processes, these cleanrooms call for a high level of environmental and contaminant control that stainless steel tables can’t always meet. 

Cell and gene therapy cleanrooms require special, more controlled types of cleanroom workstations. We’ll discuss a few of them below. 

4 Types of Cell & Gene Therapy Cleanroom Workstations

Designing a cell and gene therapy cleanroom? You’ll want to understand what these four cleanroom workstations are, what they do, and why they’re necessary for your processes. 

1. Laminar Flow Hoods 

Laminar flow hoods are enclosed devices designed to carefully guide HEPA- or ULPA-filtered air so that it sweeps particles in a uniform direction and at a uniform speed across the work surface. The direction is from the laminar flow hood’s most treated area (the filter) to its exit area. This ensures that all sensitive materials placed on the workstation are upstream and not affected by contaminant particles. 

There are two main types of laminar flow hoods: horizontal and vertical. Both generate a sweeping action and can meet ISO Class 5 requirements, but there are a few key differences in how they perform, and therefore which applications they’re best used for.  

• Horizontal laminar flow hoods direct air horizontally — pulling air from behind the hood, then pushing it through a HEPA or ULPA filter to move forward across the workstation before exiting. This allows for low turbulence, easy positioning of materials, and reduced contamination from hands and gloves (since the operator is downstream). 
• Vertical laminar flow hoods direct air vertically — pulling air from above the hood, then pushing it through a HEPA or ULPA filter to move downward onto the workstation until it disperses and exits the enclosure. This is great for applications requiring enhanced operator safety or accommodations for tall and large materials. However, vertical air hitting a perpendicular surface could cause apotential increase in turbulence, and possibly contamination. 

2. Biosafety Cabinets

Biosafety cabinets are similar to laminar flow hoods but have additional layers of protection for the operator and surrounding environment. They should be used when materials or processes present an increased safety risk to the people or space outside of the cell and gene therapy workstation. 

Biosafety cabinets use negative pressure to keep operators and environments safe. Negative pressure occurs when the air pressure in the biosafety cabinet is lower than the air pressure in the cleanroom. It’s achieved by filtering air out of the cabinet. The HEPA or ULPA filter captures contaminant particles before the air is exhausted back into the cleanroom or externally vented to the outside. 

There are three biosafety cabinet classes: 

• Class I biosafety cabinets protect the cleanroom operator and environment, but not the materials. They have open access to the work zone. 
• Class II biosafety cabinets protect the cleanroom operator, environment, and materials. They have open access to the work zone. 
• Class III biosafety cabinets protect the cleanroom operator, environment, and materials to the highest degree. They’re necessary when dealing with biosafety level 4 agents or any other highly hazardous sample. They are fully enclosed cabinets with sealed glove assemblies to avoid operator contact with hazardous materials. 

3. Isolators

Isolators are another type of clean air device used to completely separate a material from cleanroom operators and the surrounding environment. They’re required when a very high level of protection is needed from external conditions and contaminants. They can meet ISO Class 5 requirements. 

In cell and gene therapy cleanrooms, isolators are typically used for aseptic filling processes. Cleanroom operators perform tasks through sealed glove assemblies that ensure no materials are harmed. 

There are two main types of isolators: closed and open. 

• Closed isolators eliminate external contamination by transferring materials via aseptic connection to auxiliary equipment. They’re sealed throughout all operations and have no openings. 
• Open isolators have one or more openings, so that materials can be inserted or taken out at any time. The openings are designed to stop contaminant particles from entering. 

4. Hypoxic Workstations

Hypoxic workstations are enclosures that allow for strict control over oxygen, carbon dioxide, temperature, and humidity. They’re focused on both contamination and environmental control to a high degree. 

The most important feature of hypoxic workstations is that they can control oxygen in 0.1% increments, all the way from 0.1-20%. They can also meet up to ISO Class 3 requirements and are outfitted with glove assemblies to ensure particle control. 

This extreme control over environmental factors can be useful in many cleanroom industries but is especially beneficial in biological applications like cell and gene therapy. In order to culture cells safely, effectively, and repeatedly, optimal environmental conditions are necessary. 

Start Your Cell & Gene Therapy Cleanroom Project with Angstrom Technology

If you’re planning to install a cell and gene therapy cleanroom of your own, our team can develop a design that will accommodate whatever type of workstation it requires. As an industry leader in cleanroom solutions, we have the skills, knowledge, and experience it takes to bring your cleanroom to life, operating safely and efficiently for years to come. To get started, contact us for more information.

Designing and installing a large cleanroom is a lot different than designing and installing a small one — but how exactly? Let’s take a look at some cleanroom design considerations you should make at the start of a large project so that you end up with a finished space that optimizes process flow. 

7 Considerations for Designing Large Cleanrooms

Designing a large cleanroom is no small feat, as there are many factors to consider. It’s important to carefully plan everything out during the design process, so that building and installation go as smoothly as possible, and so you don’t waste any time or money fixing mistakes. 

With the right knowledge, tools, and support, designing a large, complex cleanroom is more than possible. Here are seven key considerations you’ll want to make before starting. 

1. Project Timeline

Simply put, if you have a large cleanroom project, every part of the design, build, and installation process will take more time. While it’s difficult to estimate timelines without knowing the specific size and design complexity of your cleanroom, you can expect them to be similar to these ranges for larger cleanroom projects: 

• Design: 1-6 months
• Fabrication/Production: 4-12 weeks
• Installation: 2-16 weeks

2. Cleanroom Resources & Materials

More complex cleanroom projects generally call for more resources and materials, which could include any of the following: 

• Structural components
• Process piping
• Machines/equipment
• Furniture
• Filters
• Casework
• Control systems (access doors, environmental, generators, UPS systems, etc.)
• And more!

All of these materials and equipment require the introduction of various vendors, suppliers, and trade partners, which we’ll touch on a bit more below. But this brings up the fact that more resources doesn’t just mean equipment and materials — it also means bringing in more labor resources, or workers to coordinate with. 

3. Cleanroom Cost

Additional time and resources often come with additional costs. Of course, cleanroom cost is dependent on more factors than just size. But if all those other factors remained the same, a bigger cleanroom would likely cost more than a smaller one. This is an important consideration to take into account during the cleanroom design process, so you can be sure to stick to any budgetary constraints you have. 

4. Project Trade Partners

As we briefly mentioned above, bigger, more complex cleanroom projects often require you to work alongside more vendors, suppliers, and trade partners. People like electricians, facilities managers, contractors, HVAC specialists, and plumbers can all be pulled in to manage their parts of the process. 

Working with this many trade partners requires constant, effective communication and collaboration between all parties. Otherwise, there can be detrimental setbacks or holes in design — extending your project timeline further than you originally hoped. 

If you’re worried about managing all these different professional relationships, make sure you hire a reputable, experienced cleanroom manufacturer. They’re likely to have existing relationships with high-quality trade partners, which can help ensure a smooth design, build, and installation process. 

5. Type of Cleanroom

There are four types of cleanrooms: Seamless, HardWall, SoftWall, and RigidWall. While the type you need heavily depends on your cleanroom requirements and ISO classification, Seamless and HardWall cleanrooms do typically lend themselves to larger, more complex projects. These robust wall systems allows for greater versatility and design customization. And, if you wish to expand your cleanroom even more in the future, HardWall cleanrooms are set up best to make these accommodations. 

6. Cleanroom Filtration

The amount of filtration your cleanroom needs is mostly dependent on its application and ISO classification — not so much its size. However, it’s still important to maintain the required ceiling coverage and furniture placement for optimal air movement. 

To be more specific, you need to put careful thought into where your filters will be placed in the cleanroom ceiling grid, and what types of work surfaces, furniture, and equipment will be directly below them. That way, when you have unidirectional airflow, the air can move straight down and suffer minimal disturbance — helping to maintain a uniform pattern for peak cleanliness and control. 

7. Cleanroom Airflow & Pressure

Large cleanrooms frequently include multiple different cleanroom rooms or zones. In each of these zones, different operations can be performed, which most often require different levels of cleanliness and control. 

That said, most large cleanroom projects require special attention to cascading pressure patterns. This is when the most stringent cleanroom zone has the highest level of pressure, and the least stringent cleanroom zone has the lowest level of pressure — all of which work to ensure the flow of contamination is from most clean to least clean. 

Have a Large Cleanroom Project? We Can Help!

Big cleanrooms come with big responsibilities. If you need help designing and installing one that meets your facility’s unique needs while complying with industry standards, contact us at Angstrom Technology. Our experts have the skills and experience needed to tackle any cleanroom project — no matter what design challenges it may present.

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. 

One of the final decisions you’ll have to make in regards to cleanroom design is what additional features and technologies your cleanroom may require — and cleanroom glove boxes are necessary, and most often required, in specific stringent applications. Below, we’ll explore more about what a cleanroom glove box is, what it’s used for, and under which circumstances you may need to incorporate one into your cleanroom’s design. 

What Is a Cleanroom Glove Box?

A cleanroom glove box is a sealed containment system that provides a controlled atmosphere for handling the contents within. In most cases, cleanroom glove boxes are manufactured with acrylic, static-dissipative PVC, and/or stainless steel, and they include one or more sets of gloves, allowing operators to work with objects while still upholding strict isolation protocols. 

Two Main Types of Glove Boxes

There are several different types of cleanroom glove boxes, but they all generally fall into two broad categories: “isolation” and “containment.” The difference between these two types is based on what you hope to protect, and which type of pressure is needed to protect it. 

• Isolation glove boxes use positive pressure to isolate sensitive materials from the elements and contaminants in their surrounding environment.
• Containment glove boxes use negative pressure to protect cleanroom operators from any hazardous materials or substances within the box. 

Glove Box Capabilities and Features

As far as capabilities and features go, glove boxes operate very similarly to your overall cleanroom. They’re typically referred to as your primary engineering control (PEC) and provide ISO 5 classification within the containment system. It’s then placed within the cleanroom, or the secondary engineering control (SEC) which has a lower ISO Classification. They provide an additional layer of isolation and protection — meeting slightly more stringent cleanliness requirements. 

For example, some of the most basic glove boxes capabilities and features include:

• Exhaust/recirculation connections and control
• Redundancy
• HEPA/ULPA filtration
• 2-4 glove ports (single or dual operator)
• Air locking
• Personnel & product protection
• Differential pressure
• Mobile or stationary

What Is a Cleanroom Glove Box Used For?

Glove boxes date all the way back to the 1940s, when they were used by the military to research radioactive materials. After that, they started gaining popularity in the medical field as a way to handle viruses and create various medications and vaccines. Today, cleanroom glove boxes’ controlled environments benefit a number of unique applications in a wide range of industries. 

Which Applications Need Glove Boxes in Their Cleanroom Design? 

The possibilities are truly endless here. You’ll likely see glove boxes in medical, laboratory, pharmaceutical, biological, chemical, and microelectronic cleanrooms most often, but they can also be incorporated into the cleanroom design for any other application that requires them. 

Get the Cleanroom Design Features You Need at Angstrom Technology

Does your cleanroom require a glove box, or some other additional feature or technology? We can help! With years of proven experience, our team at Angstrom Technology is able to design a cleanroom that meets all of your facility’s specifications. Talk to one of our design engineers to get started today.

Not sure where to start? We can help! Here are a few simple, yet critical factors to consider when designing your cleanroom, so you can set yourself up for a smooth design and installation process and get the most out of your investment. 

4 Key Considerations for Effective Cleanroom Design

While there are many factors to consider when designing your cleanroom, these are the four that our experts at Angstrom Technology have deemed most important to a successful, rewarding project: 

1. Determine Your Project Budget Early

There’s nothing that derails a project quite like paying more than you wanted to. As with any other construction project, determining your budget early on can help you avoid financial stress or hardship later on. It’s important that you work with your cleanroom manufacturer to understand how much your cleanroom may cost based on your unique specifications. In most cases, the following five factors will have the most effect on cleanroom cost:

• Size – The bigger, the more budget you’ll want to allocate. 
• Type – HardWall, SoftWall, and RigidWall cleanrooms all have unique features and cost varying amounts. In most cases, you’ll spend more on a HardWall or RigidWall cleanroom than you will a SoftWall cleanroom.
• Classification – The more stringent your ISO classification, the more fan filter units (FFUs) and equipment it will require, and the more it will cost you. 
• Design complexity and additional features – If your cleanroom requires extra features like process piping, furniture, static control, or gowning rooms, it will need to accommodate specific design complexities that come at an additional cost. 

2. Consider a Modular Cleanroom for Greater Design Flexibility

Modular cleanrooms are cleanrooms that are constructed with prefabricated components. They perform just like traditionally built cleanrooms, but with labeled components that are precisely pre-cut and pre-finished, they’re faster and easier to install — and require less routine maintenance.

Another big advantage of modular cleanrooms is their unparalleled versatility. They’re built “backward compatible,” which means they can be minimized, expanded, or reconfigured to meet the changing needs of your facility’s operations. This feature makes modular cleanrooms extremely rewarding long-term investments. 

3. Choose the Right ISO Classification for Your Application

Your cleanroom’s ISO classification refers to the maximum acceptable number of particles (by size) in the air, per cubic meter. That said, in order to figure out which classification your application requires, you’ll want to have a good understanding of the particle size you need to filter out. 

Building a cleanroom for a pharmaceutical production line? You’ll likely need to meet more stringent classification standards and filter out even the smallest of particles. Manufacturing basic automotive parts? Your automotive cleanroom is probably better suited for a lower classification standard, but still one that’ll filter out large particles. 

Keep in mind, however, that the more stringent your classification is, the more your cleanroom costs will be. So while building a cleanroom with a higher classification than you actually need won’t do any harm production-wise, it usually doesn’t make financial sense. Find the sweet spot, and stick to the lowest possible cleanroom classification that still meets your application’s requirements. 

4. Understand Your Process Flow

The final consideration you should make while designing a cleanroom that works for you is your process flow. It’s important to understand how your personnel and products will go about entering the room, exiting the room, and everything in between. Establishing this operational protocol will help you decide where the best placements may be for certain work surfaces, equipment, and filtration units, in addition to understanding the space needed for access around these items. 

Perhaps the best way to do this is to create a conceptual drawing of your cleanroom design, insert your intended furniture and equipment, then draw arrows along the intended paths your personnel and products will take. Seeing these things drawn out visually can give you a better idea of how they’ll actually play out once the design is brought to life — and nailing down this operational flow can help accomplish so much in terms of meeting the requirements for optimal cleanroom performance. 

Trust Angstrom Technology to Help with Cleanroom Design

Planning the design for your new cleanroom or redesigning an existing one? Let the experts at Angstrom Technology help. Our design engineers can help you make the tough choices and ensure you receive a cleanroom that’s perfect for your application. Contact us today to learn more.