Cleanroom Installation FAQs

Cleanroom Installation FAQs

by | Feb 25, 2022 | Cleanroom Installation

Looking for more information about the cleanroom installation process? You’re in the right place. Below, we’ve answered ten of our most frequently asked questions regarding cleanroom installation, so you can gain a better understanding of what the process involves. 

How Much Space Will My Cleanroom Need?

It depends. To determine the right size for your cleanroom, you’ll want to consider how much space you’ll need to adequately house your operations. Consider the appropriate amount of space for factors like equipment, workers, and walkways in which workers can move around. 

You’ll also want to keep vertical space in mind. In order to accommodate fan filter units which sit approximately 12-15” inches above the ceiling grid, and to make sure they can function correctly, you should allot for 24”-36” inches overhead clearance. This will ensure that there’s enough space for the filters to obtain air, and for your workers to carry out regular maintenance tasks. 

One other major factor to consider? Only use the space you absolutely need. If you install a cleanroom that’s bigger than what your application requires, you’ll just waste time and money. 

Are Modular Cleanrooms Easier to Install? 

Yes. Modular cleanrooms are built with prefabricated and pre-wired components that are precise and ready to install upon delivery. This generally makes the installation process much easier and quicker than that of traditionally built cleanrooms. 

How Much Does It Cost to Install a Cleanroom?

Cleanroom installation costs vary from project to project. In most situations, the cost depends on the following factors: 

However, there’s one way that you can drastically cut down your cleanroom installation costs, regardless of any of the factors listed above: build modular. Building with prefabricated, pre-wired components results in a much faster installation, reducing labor costs. 

Can I Install a Cleanroom in an Existing Space and/or Around Existing Equipment?

Yes and yes! It can be difficult to decide where to install your cleanroom, but the bright side of that is that you do have choices. Modular cleanrooms can be installed in most existing buildings as free-standing structures, or they can be tied into the existing building (this all depends on the footprint, obstructions within the facility, and structural integrity of the existing building). Modular cleanrooms are so versatile that they can even be installed around an existing piece of equipment within your facility if need be. 

Interested in seeing this in action? Check out our case study about the pharmaceutical packaging cleanroom we built around a large piece of existing equipment for Praxis, a West Michigan-based contract packaging company. 

Can I Use My Own HVAC System?

Yes, your cleanroom can be connected to your facility’s existing HVAC system — as long as it can handle the new load your cleanroom requires and guarantee it will meet the required temperature and humidity specifications without an issue. While integrating with your existing HVAC system is generally the most economical way to go, the majority of cleanrooms, no matter the ISO classification, will need more capacity and additional features than your existing system can handle. Therefore, it is best to have an independent, dedicated cleanroom HVAC system installed. 

Do I Have to Install My Cleanroom on My Own, Or Can Somebody Do It for Me?

You don’t need to install your own cleanroom. At Angstrom Technology, we employ a team of experienced cleanroom construction specialists that can come out, install your cleanroom for you, and ensure all the details are right. That way, you’ll suffer minimal disruption to your work day and operations while we get the job done for you. 

How Long Does the Cleanroom Installation Process Take?

Although the modular cleanroom installation process can vary based on the size and complexity of your design, it’s usually very quick. Prefabricated modular components are made for a high level of efficiency, reducing between 25-75% of labor time when compared to traditional cleanrooms. 

Once you’ve completed your cleanroom design and once all the prefabricated components have been delivered, the installation process usually only takes a few weeks, and some smaller cleanrooms can be installed in just days! 

When Can I Start Using My Cleanroom After It’s Installed?

Once installation is complete, there are a few things you need to do before you can start operating within it. First of all, you should ensure that all of your equipment, machines, and materials are in it, in the right spaces and are operating as intended. Then, you need to get your cleanroom air balanced, cleaned, certified, and validated so that you can ensure it’s meeting the conditions required by your ISO classification. After those steps, you should be ready to start operations!

How Can I Keep My Cleanroom in Good Condition Once It’s Installed? 

The best way to keep your cleanroom in good condition post-installation is to keep up with regular cleanings and maintenance tasks. Not only do most cleanrooms require daily cleanings, but they also require frequent filter inspections and replacements. You can find a more detailed list of maintenance tasks here. 

Can I Expand My Cleanroom in the Future?

Yes. Modular cleanrooms are extremely versatile, so they can easily be downsized, expanded, and reconfigured whenever you need. No matter what the changing needs of your facility may be, a modular cleanroom can keep up with them and offer a long-lasting investment. 

Have more questions about installing a cleanroom in your space? Give the experts at Angstrom Technology a call! We’d be happy to walk through your specific requirements and help design and build the best cleanroom for you.

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All About Medical Packaging Cleanrooms

All About Medical Packaging Cleanrooms

by | Feb 23, 2022 | Medical Laboratory Cleanrooms

There are a lot of steps that go into the safe research, testing, and production of medical products — but the process doesn’t stop there! Once medical products are tested and manufactured, they need to be packaged and distributed safely as well. 

That’s where medical packaging cleanrooms come in. Below, we’ll discuss these spaces in further detail, giving information about what they are, what requirements they have, and what projects Angstrom Technology has been working on lately. 

What Is a Medical Packaging Cleanroom?

As its name suggests, a medical packaging cleanroom is a controlled, filtered space dedicated to the packaging of sensitive medical materials and products. However, this is a pretty broad term given the number of medical materials and products available. 

As we’ve covered in our previous blog, there are three main types of medical cleanrooms: those for medical research, those for medical devices, and those for pharmaceuticals. Therefore, medical packaging cleanrooms are usually built to accommodate medical device packaging, pharmaceutical packaging, or both. 

What Requirements Does a Medical Packaging Cleanroom Need to Meet?

Depending on the specific type of medical product that needs packaging, one medical packaging cleanroom may have different requirements than the next. But there are still some things they all have in common. Below are a few common considerations for medical packaging cleanroom requirements:

Size

In many cases, medical packaging applications involve large pieces of equipment like packaging lines and conveyor belts. Therefore, medical packaging cleanrooms tend to be relatively larger than cleanrooms in other industries, in terms of both floor space and height. 

ISO Classification

Medical packaging cleanrooms require a good level of filtration and cleanliness, but they usually don’t need to meet the most stringent ISO standards. Since they’re mainly focused on the packaging of the product, rather than the actual production or testing of it, they’ll usually fall into ISO Class 7 or 8 range. 

Additional Design Features

When it comes to medical packaging cleanrooms, the additional design features and technologies needed vary from company to company and application to application. However, most include gowning rooms, a material airlock, and at least one area for parts storage. 

Angstrom Technology’s Recent Medical Packaging Cleanroom Projects

At Angstrom Technology, we’ve completed a number of cleanroom projects within the medical industry — but recently we’ve been excited to share some of our unique medical packaging projects! Completed within the past couple of years, these projects have ensured consistently controlled operations for our clients and have even resulted in some long-term relationships and additional projects. 

Medical Packaging Cleanroom 

In 2021, Angstrom completed a huge, 32,000 square foot cleanroom project for a medical packaging company in West Michigan — in just four months! The cleanroom is now able to fit numerous large pieces of medical packaging equipment, as well as the large number of workers needed to operate them. It also features the following specifications and technologies: 

  • ISO Class 8
  • Seamless Construction
  • 24’ Suspended Walkable Ceilings
  • High-Speed Roll-Up Doors
  • Automated HEPA Controls & Pressure Sensors Linked to BMS through BACnet

To view featured videos and photos from this project, visit our Medical Packaging Cleanroom Project page. 

Pharmaceutical Packaging Cleanroom 

Back in 2019, Angstrom worked with Praxis, a Michigan-based, contract packaging company, to design, build, and install a 2,120 square foot cleanroom for their OTC and prescription pharmaceutical packaging applications. This project brought a unique challenge to our team because the cleanroom needed to be designed and installed around a large piece of existing equipment in the facility — and on a tight timeline. 

But by employing two expert crews to handle the job, Angstrom was able to deliver a quality cleanroom solution on time, eventually resulting in Praxis becoming a long-term customer and requesting two more identical pharmaceutical cleanroom projects. Specific cleanroom features and technologies are listed below: 

  • ISO Class 8
  • Gowning Room and Parts Storage Room (both ISO Class 8 as well)
  • 14’ Internal Ceiling Height
  • Epoxy Floor

To discover more details about this project, read our case study that was featured on Cleanroom Technology’s website. To view featured videos and photos from this project, visit our Pharmaceutical Packaging Cleanroom Project page. 

Hoping to install a medical packaging cleanroom in your facility? Contact Angstrom Technology! Our engineers have nailed down processes for design, building, and installation that are both efficient and effective. We’re excited to take on any challenges your cleanroom project may present. And, with an extensive portfolio of successful projects, we’ve proven our ability to achieve quality, consistent results. 

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What Are Radiopharmaceuticals?

What Are Radiopharmaceuticals?

by | Feb 21, 2022 | Pharmaceutical Cleanrooms

Here at Angstrom Technology, our experts have recently put the finishing touches on another exciting project: a radiopharmaceuticals cleanroom! 

Not sure what a radiopharmaceuticals cleanroom is, or what it entails? We’ll walk through the details below. 

What Are Radiopharmaceuticals?

Radiopharmaceuticals are a group of pharmaceutical drugs that contain radioactive isotopes. In most cases, they’re used as diagnostic agents that help doctors detect a variety of medical problems. After a patient is given a small amount of a radiopharmaceutical drug, it either passes through or is absorbed by the intended organ. Then, once the radioactivity is detected, special imaging equipment is used to take pictures that allow the doctor to study how the organ is functioning. 

In addition to that very cool application, radiopharmaceuticals are also gaining recognition and popularity as a viable form of therapy or treatment for certain types of cancer, among other life-threatening diseases. In those cases, the radiopharmaceutical drug is absorbed in the cancerous area and works to destroy any affected tissue. 

That said, radiopharmaceuticals (especially those used for therapeutic and treatment purposes) make up a relatively new sector within the medical and pharmaceutical industries. The number of radiopharmaceuticals in clinical use continues to grow rapidly, allowing the medical community to better understand different diseases, as well as the best treatments for them. 

Key Considerations for Radiopharmaceuticals Cleanrooms

Just like any other pharmaceutical or medical cleanroom project, radiopharmaceuticals cleanrooms require the same basic considerations to get started: 

  • Budget
  • Size
  • Type
  • ISO classification

However, they also present a unique challenge. In traditional pharmaceutical applications, the main purpose of a cleanroom is to protect drugs from any contaminants that could reduce their safety or effectiveness. While that’s still important in radiopharmaceutical applications, there’s another huge component to consider: the safety of cleanroom operators and facilities. 

Radiopharmaceutical drug production requires a highly controlled environment that’s properly equipped to store, prepare, fill, and pack radioactive materials safely. This often means implementing a number of specialized machines and technologies, including (but not limited to) access control systems, isolators, fume hoods, and hot cells. 

The bottom line is that, after everything is designed, constructed, and installed, all components should work together to ensure the safety of both the drugs being handled and the people handling them. 

Angstrom Technology’s Latest Radiopharmaceuticals Cleanroom Project

Our recent radiopharmaceuticals cleanroom project, completed in October 2021, was for an advanced radiopharmaceuticals research and development company with a focus on cancer treatment. Based in Grand Rapids, Michigan, this cleanroom totaled 3,200 square feet and held 17 internal rooms for various operations. Below are more details on the project: 

  • Cleanroom type: HardWall
  • ISO classification: ISO 7 & ISO 8
  • Internal ceiling height: 10’
  • Additional design features and technologies: extensive door and access control system, isolators, hot cells

To view the project video and featured images, visit our Advanced Radiopharmaceuticals Cleanroom Project page. 

If you’re interested in learning more about the unique cleanroom projects we’ve completed here at Angstrom Technology, check out our Projects page. Or, if you’re ready to get started on your own cleanroom project, get in touch with our team. We’re happy to guide you through our proven design, building, and installation processes, ensuring you a final result that accommodates the needs of your facility and application. 

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Fire Safety in Aerospace & Defense Cleanrooms

Fire Safety in Aerospace & Defense Cleanrooms

by | Feb 14, 2022 | Cleanroom Safety Information

Aerospace and defense cleanrooms already work hard to protect sensitive equipment and materials from the various risks associated with contaminant particles. However, designers also need to be aware of another significant risk these cleanrooms can bring to facilities, materials, and operators: fires. 

Due to the high-velocity, constantly moving air flow within them, cleanrooms present a unique challenge for traditional fire prevention and suppression. But when you’ve spent the time, energy, and money to install one in your facility, it’s critical that you’re doing everything you can to protect your investment and keep operations running. 

Here’s an overview of some of the most common cleanroom fire hazards, as well as some tips on how to prevent them. 

Fire Hazards in an Aerospace & Defense Cleanroom

Cleanrooms need to have high air exchange rates, fast air velocities, and uniform air flows to consistently filter contaminant particles out of the space. However, these operating conditions have a negative consequence when it comes to fire control. They make it much more difficult to detect a fire with standard fire detection and suppression systems — often resulting in fires being detected too late, after damage has already occurred. 

To prevent these scenarios from happening, two things are important: 1) understanding the common fire hazards within your cleanroom, and 2) knowing the right tools and techniques to prevent them. 

First, let’s dive into three of the most common cleanrooms fire hazards, which are listed below: 

1. Short-Circuits

Cleanrooms are designed to host various types of machinery and equipment. For this reason, they’re usually equipped to handle a large electrical load. However, there’s always a chance of equipment overloading or short-circuiting that could cause them to catch fire. 

2. Improper Handling of Heat Sources

From hot air guns to Bunsen burners, there are many heat sources that can be used within an aerospace and defense cleanroom. If any of them are mishandled or stored improperly, they can result in disastrous damage. 

3. Leaking of Highly Flammable, Pyrophoric Materials

If your cleanroom deals with any liquids that can spontaneously combust on contact with air or moisture, it’s important to diligently store and secure them. Otherwise, they have high potential to leak and cause a fire or explosion. The same goes for any explosive concentrations of gases or solvent vapors. 

Fire Safety Tips for Aerospace & Defense Cleanroom Design

Looking at each of those hazards, it’s easy to get nervous about something tragic happening to your own facility or employees. The good news? Most often, cleanroom fires are preventable (or at least easier to suppress and minimize damage) with the proper tools and protocols. We’ve outlined the three most important cleanroom fire safety tips below: 

1. Invest in Specialized Fire Detection Equipment

Standard fire detection systems don’t always provide the best results in cleanrooms. However, there are specialized fire detectors that are specifically designed for controlled cleanroom environments. They actively work to collect random air samples at various suitable points within your cleanroom, so that any smoke can be detected at an earlier stage. 

Specialized fire detectors are often integrated with voice alarms and fire extinguishing systems as well. That way, all systems can be activated as quickly as possible and can respond to any fire hazards that are detected. 

2. Install Multiple Types of Fire Suppression Systems

In many cases, aerospace and defense cleanroom operations involve the handling of materials that, when combusted into flames, cannot be extinguished with water alone. For that reason, you should generally ensure that your cleanroom has multiple types of fire suppression systems. 

Most often, you’ll find that properly protected cleanrooms have a water-based sprinkler system. However, they’ll also usually install various fire extinguishers that are filled with inert gases (argon or nitrogen). That way, no matter the cause of the fire, their facility and employees are well-protected. 

3. Implement a Plan for Orderly Evacuation

When you think of a normal fire drill/evacuation, your immediate response is likely to just get out — wherever you can, however you can, as fast as you can. But with cleanrooms, this process often needs to be a little different, mostly because you don’t want to risk the release of any toxic substances that may be held within them upon exiting. Therefore, it’s important to put an orderly evacuation plan in place, and to make sure your cleanroom operators understand it.

Even better? Many cleanroom facilities invest in voice evacuation systems that alert and inform personnel of the situation, transmit clear instructions, and detail a safe evacuation plan. They’re a great resource to ensure proper protocols are followed, even in the event of a stressful emergency. 

Need to boost your cleanroom’s fire safety measures? At Angstrom Technology, we’re here to help. Our engineers can design cleanrooms that incorporate a variety of design features, including fire suppression and alarm systems. To get started on yours, give us a call or contact us online today. 

 

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Pharmaceutical Cleanroom Maintenance Tips

Pharmaceutical Cleanroom Maintenance Tips

by | Jan 31, 2022 | Helpful Tips

If you work in the pharmaceutical industry, you know that even the slightest bit of contamination could drastically disrupt your production line and affect the safety of consumers. Because of this, it’s not only important to perform operations within a cleanroom, but it’s also important to keep that cleanroom well-maintained. 

You should think of your cleanroom just like any other piece of equipment. It needs a little tuning up here and there to keep it running as it’s intended. Let’s take a closer look into what regular maintenance looks like for pharmaceutical cleanrooms. 

Looking for examples of our work with pharmaceutical cleanrooms at Angstrom Technology? Check out this case study on a pharmaceutical cleanroom we designed and installed for our client, Praxis. 

Pharmaceutical Cleanroom Maintenance Tips

When it comes to pharmaceutical cleanrooms, there’s one main category of contaminants that could disrupt your operations: process- or human-related contaminants, such as dirt, skin, hair, clothing fibers, etc.

In order to combat these contaminants, most facilities have their own unique method and schedule for cleanroom maintenance. But if you’re new to the cleanroom world and you’re wondering where to start, the following sections outline some of the most basic cleanroom maintenance tips to keep in mind. 

Day-to-Day Cleanroom Maintenance

The most tried-and-true method of keeping your cleanroom in good operating condition is to diligently adhere to daily cleaning tasks. You’ll want to do the following at least once per shift: 

  • Wet mop floors with an ISO-recommended mop, cleaning solution, and deionized water
  • Change sticky mats (if applicable)
  • Wipe walls with an ISO-recommended mop and cleaning solution
  • Wipe furniture, tables, and work surfaces with ISO-recommended wipes and cleaning solution
  • Clean pass-through chambers and other additional features with ISO-recommended wipes and cleaning solution (if applicable)
  • Remove trash, soiled garments/PPE, and waste

Something to keep in mind — while accomplishing each of these tasks, it’s best to think of your cleanroom divided into four sections: ceilings, walls, surfaces, and floors. Then, clean each area following that particular order, from the highest point of your room (ceilings) to the lowest point (floors). This helps to reduce the risk of transferring contaminants from one area to another or counterproductively dirtying a workspace you’ve just cleaned. 

Filter Maintenance

Your filtration system is responsible for filtering the air that is constantly circulated in and out of your cleanroom. Since they’re usually operating on a 24/7 basis, these filters need to be serviced and changed with some sort of frequency. There are two main components of your filters that require regular servicing: 

  • Pre-filters are the outermost filters and, in most cases, are located in the return air grilles. They are easily accessed from within the cleanroom, and should be checked on a quarterly basis to see if they need to be replaced. By changing out the pre-filters with some sort of frequency you will extend the life of your HEPA/ULPA filter.
  • HEPA/ULPA filters do the heavy lifting in the filtration process and therefore are more of an investment — in terms of both labor and finances. ULPA filters remove 99.9995% of particles 0.12 microns or larger. HEPA filters remove 99.99% of particles 0.3 microns or larger. These filters typically sit inside the fan filter housing which is installed in the ceiling grid. But with proper pre-filter maintenance and replacements, HEPA/ULPA filters can last up to 8-10 years, depending on the cleanliness of the surrounding facility. 

Additional Equipment Maintenance

From glove boxes to pill packaging conveyor systems, whatever equipment your cleanroom holds should be serviced according to manufacturer recommendations. Any malfunctioning machines could release contaminants or gases that pose a threat to the sensitive materials you’re handling. Always make sure your equipment is working normally before starting daily operations. Equipment typically requires bi-annual or annual servicing, calibration, and certification.

Cleanroom Maintenance Reporting

Our final cleanroom maintenance tip is to keep a thorough, detailed record of all your cleanroom maintenance efforts. We recommend setting up cleanroom maintenance protocols, documenting and outlining the following:

  • The person responsible for each maintenance task
  • A schedule for accomplishing each maintenance task
  • Contamination levels before and after cleaning and/or maintenance
  • Any “good-to-know” items or maintenance tasks that require follow-up

 

By using these protocols, you’ll help to ensure that your team sticks to all required maintenance, that your facility remains compliant with all ISO classification standards, and that your business remains profitable. 

If your company doesn’t have the capacity and/or resources to stick to regular cleanroom maintenance, don’t worry! There are plenty of resources out there for contracting maintenance and cleanroom cleaning work. Check with your cleanroom manufacturer to see if they have their own maintenance services, or if they can refer you to someone they trust. 

Looking for someone to service your cleanroom and get it back into top shape? Give Angstrom Technology a call! As experienced cleanroom experts, we’re happy to talk through your needs and find the right solutions. 

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