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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4 Types of Cell & Gene Therapy Cleanroom Workstations

4 Types of Cell & Gene Therapy Cleanroom Workstations

by | Jul 6, 2022 | Cleanroom Design

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.

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What Do the GMP Qualification & Validation Processes Look Like?

What Do the GMP Qualification & Validation Processes Look Like?

by | Jun 27, 2022 | Cleanroom Standards

In order to deem a cleanroom “GMP compliant,” it needs to meet various qualification and validation requirements. For facilities that are new to GMP standards and regulations, these processes can be a bit complicated — but we’re here to help clear things up.

Let’s discuss what the GMP qualification and validation processes entail below.

An Overview of the GMP Qualification & Validation Process

The GMP qualification and validation processes are designed to ensure all components of your cleanroom’s design, installation, operations, and performance are optimized for safe, high-quality, repeatable results. They’re critical steps in protecting the safety of both consumers and cleanroom operators. 

In order to understand the processes in more detail, it’s important to break down the difference between them.

GMP Qualification & Validation: What’s the Difference?

While GMP qualification and GMP validation may sound like the same thing, they’re not. GMP qualification generally comes first, then validation follows soon after. 

GMP Qualification

GMP qualification is the act of proving and documenting that equipment and supplementary systems are installed correctly, operate correctly, and comply with specified requirements. Qualification generally follows these four steps: 

  1. Design Qualification (DQ), which determines if your cleanroom design can meet all regulatory and process requirements. 
  2. Installation Qualification (IQ), which determines if your cleanroom is consistent with specified designs after installation is complete. 
  3. Operational Qualification (OQ), which determines if your cleanroom equipment achieves specified operational requirements. 
  4. Performance/Process Qualification (PQ), which determines if your cleanroom equipment performs well together in a controlled and repeatable manner. 

Here’s where things can get a little tricky. These qualification steps are the first part of validation. However, the steps alone aren’t the only part of validation. There’s a little more to it, which we’ll talk about below. 

GMP Validation

GMP validation is the act of documenting objective evidence that offers a high level of assurance that a specific cleanroom process will consistently deliver products that meet predetermined specifications. It follows these four steps: 

  1. Performance/Process Validation, which is step #4 of the qualification process above.
  2. Cleaning Validation, which ensures that equipment is cleaned regularly and in accordance with specified regulations. 
  3. Method Validation, which ensures that the analytical procedure for a specific task is suitable for intended purposes. 
  4. Computer System Validation, which ensures that any cleanroom software applications meet their intended purposes. 

Side Note: What About cGMP Qualification & Validation?

It’s important to note the difference between GMP and cGMP here. You may have seen “cGMP” during your research and wondered if it’s the same as GMP. It’s similar, but it’s not quite the same. 

GMP requires you to ensure your cleanroom is designed, built, and operable in a way that creates safe and effective products, whereas cGMP requires you to use technologies and systems that are modern and comply with GMP standards. Therefore, while the qualification and validation process for these two systems are similar and can be streamlined together, they are a little different. 

How Long Do the GMP Qualification & Validation Processes Usually Take?

The timeline for GMP qualification and validation can vary greatly depending on the scope of your cleanroom project. It’s usually an extensive amount of work, though, so it’s important to plan accordingly in terms of both the time and resources you’ll need. 

GMP qualification and validation happen in stages, often in accordance with the stages you design and build your cleanroom. Therefore, you can expect the entire process to take somewhere between a couple of months to a year, depending on the duration and complexity of your project. 

Who Is Responsible for Obtaining GMP Qualification & Validation?

You, the facility manager or owner of the cleanroom, are responsible for obtaining GMP qualification and validation for your new cleanroom. 

However, there are plenty of resources available to help you get there — one being a reputable cleanroom manufacturer with GMP experience. While they can’t usually carry out the GMP qualification and validation process for you, they can help you understand it, navigate it, and design, build, and install a cleanroom that meets necessary requirements. 

Design & Build Your GMP Cleanroom With Angstrom Technology

GMP qualification and validation can get confusing, especially if you’re new to the processes. If you’re looking for some help, reach out to our team at Angstrom Technology. We’ll be your guide to designing and installing a cleanroom that’s safe, efficient, and compliant with industry standards.

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Why Do I Need a Cleanroom for Plastic Injection Molding?

Why Do I Need a Cleanroom for Plastic Injection Molding?

by | Jun 20, 2022 | Plastics Industry Cleanroom

Plastic is used for various tools and applications in everyday life. But where do those plastic components come from, and how are they made? Plastic injection molding!

Plastic injection molding is the primary method of manufacturing for most plastic tools, packaging, components, appliances, and more. As most professionals in the industry know, plastic injection molding is a complex process that must be conducted in a controlled environment like a cleanroom. Let’s dive deeper into why. 

What Is Plastic Injection Molding? 

Plastic injection molding is a process used to manufacture a variety of plastic parts and devices. It involves placing molten plastic into a metal mold, then allowing it to cool until a solid structure is formed. It is used for a variety of industrial applications, including (but not limited to): 

  • Medical devices
  • Pharmaceutical packaging
  • Food and beverage packaging
  • Aerospace parts
  • Automotive parts
  • Parts used for the research and development of new products

So why does plastic injection molding need to be done within a cleanroom environment? 

Why Does It Require a Cleanroom?

Well, there are many sensitive applications where contamination can be detrimental to a finished plastic product’s safety and performance. For applications like aerospace and automotive part manufacturing, contamination during the injection molding process could decrease the level of performance. And for applications involving medical devices, food, or other consumables, contamination during the injection molding process could put human lives at risk. 

Therefore, it’s necessary to have a cleanroom that’s designed to reduce the risk of contamination while operators and equipment create these plastic components. Doing so not only ensures great product performance and consumer safety, but also protects you from having to start over and manufacture replacement products — effectively saving you from losses in efficiency and profitability. 

Unique Challenges for Plastic Injection Molding Cleanrooms

The plastic injection molding sector faces a unique set of challenges when it comes to cleanroom design and operations. These challenges are mostly due to the nature of the process and the specific types of equipment used during it. Here are a few of those challenges you’ll want to consider when planning your own injection molding cleanroom:

  • Minimizing contamination from cleanroom personnel
  • Minimizing contamination from cleanroom equipment
  • Accommodating large pieces of injection molding cleanroom equipment, such as mold cranes and mold presses
  • Allowing direct access for overhead mold cranes to enter the cleanroom through ceiling access panels
  • Allowing mold cranes to be grounded outside of the cleanroom at all times (if possible)

How to Design a Safe & Effective Plastic Injection Molding Cleanroom

So how can you design a plastic injection molding cleanroom that operates efficiently and meets all of the criteria above? Here are some tips from our experts:

  • ISO Classification — Most plastic injection molding cleanrooms are ISO Class 7 or 8. However, this can vary depending on your specific application. 
  • Type of Cleanroom — All three types of cleanrooms can be used for plastic injection molding. It’s best to ask your cleanroom manufacturer which is most suitable for your specific application. 
  • Cleanroom Size — There isn’t a minimum or maximum size requirement that your plastic injection molding cleanrooms need to meet. Just make sure it’s big enough to house the large furniture and machinery you’ll be using. Remember, choosing modular construction is a smart idea if you anticipate expanding in the future. 
  • Cleanroom Pressure — Your plastic injection molding cleanroom should operate under positive pressure in order to prevent harmful particles from entering and disturbing your process.
  • Special Equipment — Plastic injection molding cleanrooms house a few unique types of equipment, most importantly mold cranes. In most cases, you will need to consider a ceiling hatch to allow your mold crane, which is a potentially high source of contamination, to be kept outside of your cleanroom. That way, only part of the machine enters your cleanroom for tool/mold changing purposes. Another important decision to make is choosing electric machines instead of hydraulic machines, which can also reduce the amount of contamination that enters the space. 

For an example of what a plastic injection molding cleanroom may look like, check out one of our latest projects here. 

Work With the Plastic Injection Molding Cleanroom Experts at Angstrom Technology

In order for injection molding applications to be safe, effective, and repeatable, cleanrooms are necessary. If you’re looking to design a plastic injection molding cleanroom of your own, contact our team at Angstrom Technology. We’ll listen to your facility’s specific needs, then provide a turnkey cleanroom solution that meets each one of them.

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Radiopharmaceutical Cleanroom FAQs

Radiopharmaceutical Cleanroom FAQs

by | Jun 14, 2022 | Helpful Tips

 Interested in learning about the radiopharmaceutical industry and radiopharmaceutical cleanrooms? As an experienced radiopharmaceutical cleanroom manufacturer, we’re here to answer any questions you have about the design or installation of these innovative spaces. 

To get you started, we’ve listed 10 of our most frequently asked questions about radiopharmaceutical cleanrooms, along with their answers, below. 

1. What Are Radiopharmaceuticals?

Radiopharmaceuticals are a group of pharmaceutical drugs that contain radioactive isotopes. In the past, they’ve mainly been used as diagnostic agents that help doctors identify a number of medical problems. 

However, they’ve recently gained recognition for being viable forms of treatment for life-threatening conditions like cancer. For those cases, the radiopharmaceutical drug is absorbed into the cancerous area, then destroys any affected tissue. Many patients have found radiopharmaceuticals to be a less-invasive, less-painful alternative to other chemotherapy and radiation techniques. 

2. What Risks Are Associated With Handling Radiopharmaceuticals?

In traditional pharmaceutical applications, the main goal is to protect sensitive products from being harmed by contaminants. However, in radiopharmaceutical applications, there are two goals: to protect the products and to protect the people handling them. 

Why? Radiopharmaceuticals contain radioactive isotopes, which can be harmful to human health after lengthy or frequent exposures. Too much radiation exposure has been known to cause the following health conditions: skin burns, acute radiation syndrome, cancer, cardiovascular disease, reproductive issues, and more. 

3. What Is a Radiopharmaceutical Cleanroom?

As the name suggests, a radiopharmaceutical cleanroom is a controlled cleanroom environment in which radiopharmaceuticals are tested, produced, packaged, or distributed. Radiopharmaceutical cleanrooms are not the same as traditional pharmaceutical cleanrooms, as they have unique control, cleanliness, and process requirements in order to ensure patient and operator safety. They also house different types of cleanroom furniture and equipment. 

All this said, it’s important to be aware of any unique design considerations radiopharmaceutical cleanrooms require.

4. What ISO Classification Do Radiopharmaceutical Cleanrooms Require?

In most cases, radiopharmaceutical cleanrooms are required to meet ISO Class 7-8 standards. However, they may also feature some designated areas or chambers that meet even more stringent standards, such as ISO Class 6 or above. 

5. What Other Quality Standards Do Radiopharmaceutical Cleanrooms Need to Meet?

ISO standards aren’t the only quality standards that radiopharmaceutical cleanrooms need to meet. In most cases, they also need to meet GMP standards and USP standards. 

GMP stands for Good Manufacturing Practice, which is a quality management system enforced by the US Food and Drug Administration and used mainly by medical and pharmaceutical manufacturers. The main goal of these standards is to minimize the risks of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. 

USP stands for United States Pharmacopeia, which is “an independent, scientific nonprofit organization focused on building trust in the safe supply of safe, quality medicines.” USP is not a government entity, but works alongside government agencies and regulatory authorities around the world to safeguard the global supply of medicines and other consumable products. Their standards are legally recognized in the United States and are used in over 140 countries.

The main goals of these standards are to protect patient and worker safety while developing, packaging, distributing, and consuming medicines and dietary supplements. The USP standard that’s most pertinent to radiopharmaceutical applications is USP 825, which you can read more about in our previous blog post. 

6. What Types of Equipment Do Radiopharmaceutical Cleanrooms Require?

Radiopharmaceutical cleanrooms require various types of equipment, some of which are completely different from those found in traditional pharmaceutical cleanrooms. A few common types of radiopharmaceutical equipment include:

  • 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 

7. What Type of Cleanroom Is Best for Radiopharmaceutical Applications? 

Radiopharmaceutical cleanrooms require a high level of environmental control in order for drugs to be safe and effective for patient use. Therefore, HardWall cleanrooms are generally the best option, as they can accommodate that high level of control against contamination, temperature, humidity, and more. 

8. How Big Do Radiopharmaceutical Cleanrooms Need to Be?

Your radiopharmaceutical cleanroom can be any size your facility needs. However, when determining cleanroom size, it’s important to consider all the specialized furniture and equipment it needs to house. Things like hot cells and isolators aren’t small, so make sure your cleanroom can accommodate the amount that you need. 

Another important consideration is that with modular cleanroom design, you always have room and opportunity for growth. If your facility chooses to expand in the future, modular design allows for quick and simple reconfigurations and additions — but that process is only quick and simple if it’s planned for ahead of time. 

For almost all cleanroom projects, we recommend that facilities plan for this growth during the initial design phase. Considering what expansion will look like or could potentially be is an important step in eliminating additional costs or unwanted downtime within the cleanroom. 

9. What Type of Pressure Do Radiopharmaceutical Cleanrooms Require?

More often than not, radiopharmaceutical cleanrooms are actually radiopharmaceutical cleanroom suites, which contain multiple different controlled rooms or zones. Within these cleanroom suites, cascading pressure is typically required. 

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 helps ensure that contamination and particles will not flow into the most critical or cleanest zone.

10. What Radiopharmaceutical Cleanroom Projects Has Angstrom Technology Completed?

In October 2021, Angstrom Technology completed a radiopharmaceutical cleanroom suite project for Michigan State University’s College of Human Medicine and Bold Advanced Medical Future (BAMF) Health. 

BAMF Health is a key innovator in the global radiopharmaceuticals and theranostics industry. With a focus on AI-based precision medicine, molecular imaging, and theranostics, they’re working to create a cutting-edge technology that results in the most efficient, effective, and non-invasive therapeutics for life-threatening conditions like cancer, Alzheimer’s, Parkinson’s, cardiac disease, and more. 

The cleanroom facility is based in Grand Rapids, MI, and totals 3,200 square feet. Here are some of the details:

  • 17 internal rooms, sectioned into three main areas: Commercial Operations, Therapeutic Infusion, and Research and Development
  • HardWall cleanroom
  • ISO 7 & 8
  • 10’ internal ceiling height
  • Environmental control and monitoring systems in each room, all connected to the BMS
  • 18 hot cells

To learn more about this project, visit our Advanced Radiopharmaceuticals Cleanroom page.

Design & Build Your Radiopharmaceutical Cleanroom With the Experts at Angstrom Technology

With the recent development of advanced radiopharmaceutical treatments and therapies, radiopharmaceutical cleanrooms are on the rise. If you’re hoping to build one of your own, contact our team at Angstrom Technology. We can help answer your questions, guide you through the process, and install a cleanroom that meets your facility’s specifications. 

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