Medical Cleanroom Design Tips: Cleanroom Windows

Medical Cleanroom Design Tips: Cleanroom Windows

When it comes to medical cleanroom design, you are constrained by the cleanroom classification you must meet. That said, every medical cleanroom has its own unique application and processes that require an accommodating design. One common design feature of a medical cleanroom is cleanroom windows. Can your medical cleanroom have windows? And if so, what types of windows are available that provide the design you’re looking for, while meeting your specific classifications? 

Here’s what you need to know about medical cleanroom windows, from why you might install them to the different types of cleanroom windows that can suit medical cleanliness requirements. 

 

Why Install Windows in Your Medical Cleanroom?

 

Medical cleanrooms, especially those used for pharmaceutical and hospital applications, must meet some of the most stringent cleanroom classifications. It might feel that windows would only detract from the standards you’re trying to meet, but in reality, true cleanroom windows can provide the cleanliness and security you need, with a few additional benefits you may not have considered. Here are just a few reasons to install windows in your medical cleanroom:

    • Morale. A little natural light can go a long way to boost team morale. Sitting in a windowless room all day can affect your staff’s mood, and studies have shown that workers who sit by a window are more productive than those who don’t have access to natural light.
    • Lighting. Cleanroom windows can let in a significant amount of natural light. Not only does this make it easier for your team to complete their processes, but it also can help you save on electricity costs, and minimize the number of cleanroom-specific lighting fixtures you need to install. 
    • Supervision. For applications that must adhere to specific protocol, like pharmaceutical cleanrooms, windows provide the transparency your facility needs. Supervisors can easily monitor production from outside the cleanroom. This helps maintain your cleanroom classification, and minimizes the number of people within the space, without sacrificing the quality and procedure of your process. 

 

Medical Cleanroom Window Styles

 

The benefits of cleanroom windows are clear — they can help increase productivity, reduce lighting costs, and ensure proper supervision without compromising your controlled environment. Any quality cleanroom window will feature a glaze or finish that works to make the window easy to clean, sealed, and contaminant free. Glazing options for cleanroom windows include:

  • Tempered glass
  • Tinted glass
  • Static dissipative
  • Lexan™
  • Laser glass
  • Acrylic
  • Double glazing
  • Film covered glass
  • Acrylic
  • UV

A quality cleanroom supplier can provide the cleanroom window with appropriate glazing for your application and cleanroom standard. While the type of window glaze is important for any medical cleanroom, the window style you choose is a bigger consideration to make. 

If you’re considering installing windows in your medical cleanroom, here’s a look at a few of the styles most suited to your applications. 

Flush or Double Flush Cleanroom Windows

 

Flush cleanroom windows are the best option for nearly any medical cleanroom application. As the name suggests, these windows are installed flush with your cleanroom wall, eliminating any frame or sill where dust, debris, or particle might collect. 

Flush cleanroom windows are available as double flush windows, which means they’re installed directly into the wall, usually with two panes, each of which is flat with its side of the wall. Regular flush cleanroom windows can also be installed flat on the clean side of the cleanroom, with a ledge on the “dirty” side of the cleanroom. 

Beveled Cleanroom Window

 

Beveled cleanroom windows are an affordable alternative to the double flush window. The window itself is flat to the wall but features a beveled sill that eliminates any corners that dust, particles, or micro-organisms could sit on. Since a beveled cleanroom window requires just one pane of glass, it’s more cost-effective than the double-flush window while achieving a similar look and functionality.  

Floor-To-Ceiling Cleanroom Window Panels

 

The final window option available to medical cleanrooms is floor-to-ceiling cleanroom window panels. Depending on your classification, you can opt for a fully windowed cleanroom like Angstrom Technology’s RigidWall cleanrooms. Our RigidWall product offers crystal clear paneling throughout the cleanroom. This is ideal for pharmaceutical and medical applications where transparency and supervision are essential. It also offers a clean aesthetic that allows in plenty of light for your staff. 

If you’re not sure about a completely transparent cleanroom, it’s also possible to integrate just a few window wall panels to let in light, without compromising the design or standard of your cleanroom. These clear panels can meet a variety of cleanrooms classifications. Since each panel is one complete piece of glass or fiberglass, they eliminate the potential for leaks around window seals.  

Installing Cleanroom Windows for Your Medical Application

 

Cleanroom windows are an excellent addition to any medical or pharmaceutical cleanroom. They provide additional light and the transparency and supervision many medical processes require. If you’re working to integrate windows into your existing cleanroom, or if you’re designing a new cleanroom and are hoping to incorporate cleanroom windows, it’s always best to work with a cleanroom expert. 

Cleanroom windows provide a range of benefits, but proper installation is key to ensuring you get the light you need while maintaining your cleanroom’s classification. Look for a cleanroom expert with experience in medical and pharmaceutical cleanrooms, and try to find a provider that will work to help you design and install the ideal cleanroom for your unique application. 

Windows make for a more attractive cleanroom that’s easy for your investors to see and appreciate. If you’re looking to design, build, or reconfigure a cleanroom with windows, whether you’re in the pharmaceutical or medical industry, let us know. We design and install custom cleanrooms that are built to your exact specifications, from the HVAC system and classification down to the windows. Give Angstrom Technology a call at 888-768-6900 or contact us online for more information today.

3 Benefits of Positive Pressure Cleanrooms for Aerospace & Defense Industries

3 Benefits of Positive Pressure Cleanrooms for Aerospace & Defense Industries

Pressurized cleanrooms are used in a range of industries and applications. Varying levels of pressure determines the way air naturally moves in a space. High and low pressure, or positive and negative pressure, can be used as a tool in cleanroom environments to protect against entering contaminants (in positive pressure cleanrooms) or contaminant leakage (in negative pressure cleanrooms). 

We’re going to focus on positive pressure cleanrooms, how they work, and the benefits they offer to aerospace and defense cleanrooms

 

What are Positive Pressure Cleanrooms?

 

Positive pressure cleanrooms have greater air pressure in the cleanroom than the outside environment. In a positive pressure cleanroom, clean, filtered air is consistently pumped into the room through the HEPA filtration and cleanroom HVAC system. In the event that a door or window was opened in the cleanroom, air would rush out into the outside environment. 

This positive pressure ensures that in the event of a breach or leak in the cleanroom, the products and processes within the cleanroom are protected. Because the cleanroom has positive pressure, the air is forced out of the cleanroom, preventing contaminated or unfiltered air from seeping in. 

Positive pressure cleanrooms are most commonly used in applications where the cleanliness of the air within the cleanroom is more important than the air quality outside the cleanrooms. For highly technical applications like microelectronics, aerospace, and defense, where the tiniest particle can damage the quality of the manufactured product, a positive pressure cleanroom affords a number of benefits. 

 

3 Benefits of Positive Pressure Cleanrooms for Aerospace and Defense Industries

 

Positive pressure cleanrooms are beneficial to a wide range of applications. For microelectronics, they afford the cleanliness standard required to minimize damages to electronic components like microchips. For hospital and healthcare applications, positive pressure cleanrooms provide the controlled environment healthcare professionals need to keep patients safe. 

But outside these common applications, positive pressure cleanrooms also provide a wealth of benefits for other industries. Let’s look at three benefits of positive pressure cleanrooms for aerospace and defense industries:

 

#1 Maintain Cleanroom Classification

 

One of the key benefits of a positive pressure cleanroom for aerospace and defense industries is the cleanroom’s ability to maintain its classification. Because clean, filtered air is constantly being pumped into the cleanroom, it’s very difficult for contaminants or particles to enter. Particles must work against the flow of air to enter a positive pressure cleanroom, which helps to keep your cleanroom at its required classification. This ensures your cleanroom is able to regulate itself with ease, with minimal maintenance or upkeep from your staff. 

 

#2 Keep Out Debris and Particles

 

For aerospace and defense cleanroom applications, debris and particulate can be exceptionally damaging. When you’re working to manufacture sensitive products like microchips, defense products, aircraft, or even spacecraft, the smallest particle can affect the quality of the manufactured product. 

Positive pressure cleanrooms work to assist aerospace and defense applications by making it very difficult for debris and particles to enter the cleanroom. Even when an employee is entering a cleanroom or opening a pass-through, the positive pressure of the cleanroom forces the excess air in the room out, minimizing the potential for contaminated air or particulate to enter the cleanroom. This is particularly useful in research and manufacturing applications where a highly controlled environment is key to the success of the project or process. 

 

#3 Protect Sensitive Work

 

Many aerospace and defense applications deal with sensitive electronics and sensors and navigation system calibration. This type of work requires a well-controlled environment. Even the smallest particle can disrupt sensitive navigation systems or compromise the quality of a sensor or microchip. 

For aerospace and defense applications like this, a positive pressure cleanroom provides the necessary level of protection from contaminants. A positive pressure cleanroom is first developed to meet the application’s classification standards, and provides an extra level of protection thanks to the nature of positive pressure. 

In addition to meeting cleanroom classifications, the positive pressure cleanroom makes it much more difficult for debris and particulate to enter the cleanroom, protecting even the most sensitive aerospace and defense research, calibration, and manufacturing processes. 

 

Positive Pressure Cleanrooms Benefit a Variety of Aerospace and Defense Applications

 

Positive pressure cleanrooms are the ideal choice for a variety of aerospace and defense applications. From electronics and microchip manufacturing to aircraft and spacecraft production to navigation system calibration, there are a number of processes that can benefit from the extremely controlled environment a positive pressure cleanroom provides. 

Is a positive pressure cleanroom right for your application? Let the Angstrom Technology team know. We design, manufacture, and install cleanrooms for custom applications in the aerospace and defense industry and beyond. If you’re looking for a cleanroom that fits your unique application and cleanroom classification, we can help. Give us a call at 888-768-6900 or contact us online today for more information.

 

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3 Types of Medical Cleanrooms

3 Types of Medical Cleanrooms

Medical cleanrooms are vital for the work of finding medical solutions, developing vaccines and treatments through pharmacological products, and manufacturing life-saving medical devices, among other important applications. Three main types of medical cleanrooms are medical research cleanrooms, medical device cleanrooms, and pharmaceutical cleanrooms. The cleanroom design for each type will differ depending on the goals of the facility and its cleanroom classification requirements. 

Let’s take a closer look at these three types of medical cleanrooms, and how they differ in their applications, classifications, and cleanroom design. 

 

Medical Research Cleanrooms

 

Medical research cleanrooms are used in the pursuit of medical understanding, research and experimentation, and the development of treatments. Medical research cleanrooms are often required to be biosafe, and have extra safeguards in place to protect employees and their important work from potential biosecurity risks.  

The cleanroom environment must be highly sterile. Medical research cleanrooms usually fall within ISO 14644-1 Class 5-7. The rigorousness of the standard is dictated by the risk level of contaminants to cleanroom operations and safety. For example, for research involving blood or stem cells, an ISO Class 5 cleanroom environment is likely necessary. This means the cleanroom must have a powerful filtration system in place, with allowed particle count of fewer than 3,520 particles half a micron or larger. 

Medical research applications working with infectious or toxic fumes or substances often require negative pressure cleanrooms. This added safeguard keeps contaminants from inside the cleanroom from escaping where they could cause harm to those outside the cleanroom environment. 

Whether for the uses of cancer research, the study of infectious diseases and viruses, or the pursuit of potent and effective vaccinations, medical research cleanrooms are fully equipped with all the specialized equipment, safe storage, and ergonomic furniture researchers need to do their jobs comfortably and effectively. Medical research cleanrooms are usually designed with HardWalls. HardWall cleanrooms can meet even the most stringent classifications these types of medical cleanrooms may require, and are highly modifiable to any application’s unique needs. 

 

Medical Device Cleanrooms

 

Medical devices are specialized products used to diagnose, treat, and cure patients. Unlike pharmaceutical products, medical devices are not metabolized. Instead, they can be used internally and externally as a tool by medical professionals, or even implanted for a long-term solution. Because they come into contact with tissues and membranes, medical devices must be contaminant-free or able to be thoroughly sanitized to prevent the possibility of infection or other risks. For this reason, the production, assembly, and packaging of medical devices requires a controlled cleanroom environment, validated and monitored by stringent requirements and quality control. 

The different stages of medical device production, assembly, and packaging have different cleanliness requirements, and often fall under separate classifications. For example, most medical device manufacturing cleanrooms must comply with ISO Class 5-8 standards. 

More specifically, medical device cleanrooms manufacturing non-critical and semi-critical devices fall in the ISO Class 7-8 range, while devices with critical disinfection levels (like surgical equipment and implanted devices) require the cleanest environments and must comply with ISO Class 5 or greater. Essentially, the stringency of requirements increases as device part sizes become smaller and more intricate.

Medical device packaging cleanrooms, while still very closely monitored to prevent contamination, generally operate within ISO Class 7-8 standards. 

The best cleanroom type for medical device manufacturing and packaging is a HardWall cleanroom. This cleanroom type is able to comply with strict classification requirements and maintain a stable, contaminant-free environment throughout all stages of device production. 

 

Pharmaceutical Cleanrooms

 

Pharmaceutical cleanrooms are used to develop chemical treatments and cures to improve health and save lives. In the development and testing of pharmaceuticals, even the slightest contamination could have serious consequences on medical study results or treatment efficiency, and could even lead to life-threatening consequences. Because of this, the pharmaceutical industry is subject to heavy regulation.

Pharmaceutical cleanrooms often require varying levels of cleanliness depending on the type of substances, chemicals, and procedures involved in their operation. The minimum standard for pharmaceutical cleanrooms is generally ISO 7 with progressing needs of ISO 5 or more, which requires 240-600 air changes per hour and 35-70 percent ceiling coverage to maintain an environment of 100,000 0.1μm particles per cubic meter.

Pharmaceutical cleanrooms are also governed by additional regulations by US Pharmacopeia, or USP Standards. Pharmaceutical compounding spaces follow USP Standards 797 for sterile non-hazardous compounds, or the stricter USP 800 for sterile hazardous compounds. USP standards prescribe layout options according to the optimal airflow patterns, cleanroom organization, operator techniques, and sanitation levels of each standard. 

Due to the high level of control needed in a pharmaceutical cleanroom, HardWall cleanrooms are the obvious solution. Able to maintain strict environmental standards and eliminate error caused by temperature, humidity, or contamination, HardWall cleanrooms offer a reliable structure to any medical cleanroom design. 

These three types of medical cleanrooms are vital and valuable investments to businesses pursuing research or creating and preparing compounds and devices to improve health and save lives. Important work in the healthcare industry merits a high-performing medical cleanroom to keep projects and employees protected. 

From pharmaceutical development to medical device manufacturing and packaging, Angstrom Technology designs, builds, and installs medical cleanrooms for any classification standard. If you’re ready to start designing your new cleanroom, get in touch with Angstrom Technology’s professional team today.

How to Upgrade your Cleanroom

How to Upgrade your Cleanroom

As Greek philosopher Heroclitus said, “There is nothing permanent except change.” While the conditions in your cleanroom are designed to stay the same, your work rarely does. If your project needs are evolving, you might find yourself needing to meet new cleanroom classification requirements. Even a seemingly small jump to a more stringent ISO Class can be a big change for your facility. How do you make the leap? Let’s work through what upgrading your cleanroom will look like, and how to start the process. 

 

Upgrading Your Cleanroom Classification?

Start Here.

 

If you have to move to a more stringent qualification, the first thing you have to do is take a hard look at your cleanroom classification. Start with your classification as it stands and look at the specific areas you need to adjust to achieve the next level of cleanliness. To do that, we have to break down what’s in a classification. While there’s much more involved than just these three elements, the main differences between classifications are defined by:

  • Allowed particles (by number and size)
  • Air changes per hour (or airflow velocity)
  • Percentage of ceiling coverage of FFUs (filter fan units)

When upgrading your cleanroom, you’ll need to make changes to address these three areas in order to make your cleanroom more clean. In addition to ISO standards, your cleanroom upgrade will also reflect necessary changes specific to your new project or scope of work. Consider your new application or purpose and what upgrades will ensure success in your future endeavors. This could include more control over temperature and humidity, more space for equipment, cabinetry and other storage, cleanroom furniture, lighting, ESD-safe materials, or other specialized features. 

 

Redesigning Your Cleanroom

 

Whether you’re upgrading your cleanroom to meet a new classification, to match a new purpose, or both, there are several factors you should consider when redesigning your space. Your cleanroom upgrade encompasses the layout and structure of your space, your cleanroom’s systems, and how to maintain your new classification once reached.

Reconfiguring Your Cleanroom Layout

 

When redesigning your cleanroom layout, you can easily rearrange modular panels to create the new space and shape that works for your new project. Add more panels for a larger cleanroom, or remove and store extras for a more controlled, condensed space. Your upgraded cleanroom may require more space for additional personnel, large equipment, or room to move carts and transport products, so be sure to factor these potential needs into your cleanroom redesign.

If you’re upgrading your cleanroom to a more stringent classification, or your project parameters are changing significantly, you may need to choose a different structure altogether.  Consider these three types of cleanrooms for your redesigned facility:

  • HardWall Cleanrooms: Offering increased security and the highest possible control, HardWall cleanrooms are able to meet the strictest classification standards effortlessly.
  • SoftWall Cleanrooms: The most flexible cleanroom type, SoftWalls are easy to expand, reconfigure and fit in small spaces. They’re an affordable modular option with room to grow.
  • RigidWall Cleanrooms: With less flexibility than HardWalls but more stability than SoftWalls, RigidWall cleanrooms are a minimalist middle ground made of solid clear panels — great for showing off your operations to investors.

Upgrading Cleanroom HVAC System

 

Upgrading your cleanroom will likely also require upgrading the systems that support it. You may be able to update your existing cleanroom HVAC system or add a dedicated system if your new classification requires more control over temperature and humidity. A powerful and reliable HVAC system does more than just keep your employees comfortable. It also helps to maintain a stable atmosphere for any sensitive hardware or substances you work with, and prevents machinery from overheating. 

Humidity control can help avoid potential problems that come with too much moisture such as condensation and contamination, which could impact productivity by extending drying time or causing products or processes to fail. A cleanroom HVAC system that is in tune with your project and facility’s needs will keep your cleanroom clean and consistent.

Meeting New Cleanroom Filtration Requirements

 

Your cleanroom classification will specify your allowed particle count, as well as the minimum air changes needed to clean the air effectively. When upgrading your cleanroom, you will likely need to increase your air change rate and capture more and smaller particles. You can achieve this by adding more fan filter units to increase your percentage of ceiling coverage. This is also a good time to check and/or replace HEPA filters to make sure they are effectively removing particles from the air.

Additionally, rearranging your layout or furniture might require the implementation of a new airflow pattern. Furniture or equipment can block filters and interrupt the flow of air, creating pockets of turbulent air or spaces where contaminants could be trapped. To find the best airflow pattern that works with your upgraded cleanroom, work with a cleanroom design expert. They can use computational fluid dynamics to model your cleanroom airflow pattern and make decisions about layout that will improve air change efficiency and support the healthy life of your HEPA filters.

Proper airflow with effective filtration will ensure you are removing particles consistently and reaching appropriate levels for your new classification. Once it reaches that level of clean, all you have to do is keep it there.

Maintaining Your Cleanroom Classification

 

Once you’ve upgraded your cleanroom to its new classification, congratulations! Now you’re done, right? Unfortunately, reaching new requirements is only half of the battle. Most of the work lies in supporting your upgraded cleanroom with regular maintenance and cleaning. Follow through with regular maintenance tasks like cleaning procedures, replacing pre-filters, and servicing equipment to make sure your cleanroom stays in top condition. 

Your cleanroom should be checked regularly to make sure it complies with your classification standard. If your cleanroom falls in the ISO Class 5 or lower category, it will need to be monitored with particle count tests biannually, per ISO 14644-2. Cleanrooms with less stringent standards are checked once each year.

Keep up with scheduled maintenance and monitoring tasks to make sure your cleanroom meets its new standards completely and consistently.

If you need to upgrade your cleanroom to a higher classification, we can help. We’ll take a look at what you’ve got, and determine the best way to get you where you need to be. Once you’ve reached your goal, we can add you to our regular cleaning and maintenance schedule, so you don’t have to worry about consistently meeting your classification standards. Reach out to Angstrom Technology for all of your cleanroom needs today!

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What’s the Deal With Segmented Cleanrooms?

What’s the Deal With Segmented Cleanrooms?

An important part of cleanroom design is the choosing the best layout to suit your unique application. If your cleanroom has the challenge of needing to meet changing requirements or different levels of cleanliness, air changes, or pressure for different stages of work or to contain hazardous substances, it can be complicated to fit all of your cleanroom needs in one design. 

The solution to this problem is to segment your cleanroom design. Segmented cleanrooms are commonly used in medical applications that require separate spaces for different products or processes to ensure the safety of employees and their work.  Let’s explore segmented cleanrooms and their uses, and how their attributes can go beyond necessity in medical cleanrooms.

 

What Are Segmented Cleanrooms?

Segmented cleanrooms embrace different requirements and cleanroom classifications within a single cleanroom design. To do this, separate spaces are created within the cleanroom and modified to match the necessary requirements. Depending on the needs of the facility, this could mean a cascading pressure system utilizing a negative pressure room and higher pressure ante room; separate areas that meet different classifications, such as for manufacturing vs. packaging, treatment vs. isolation and quarantine, etc.; or any other separate-but-linked purposes your application requires.

Even when segmenting your cleanroom design isn’t required by your industry-specific standards or cleanroom classification, segmentation can offer added benefits like energy efficiency and cost savings. Rather than running the entire cleanroom at the lowest possible classification, a segmented cleanroom makes use of its systems where they’re most needed. This saves energy from powering FFUs and the cleanroom HVAC system, and lessens the strain on expensive HEPA filters. Also, there may be areas in the cleanroom where specialized products, like ESD-safe or classification-compliant materials, can be limited. By restricting use of those extra materials and energy costs to the segment where they’re being used, you’ll save money in your cleanroom design, build, and daily operational costs.

 

What Medical Applications Benefit from Segmented Cleanrooms?

Segmented cleanrooms are useful in medical applications where different requirements are necessary, particularly in medical device cleanrooms, pharmaceutical cleanrooms, and medical research cleanrooms.

Medical Device Cleanrooms

Medical device cleanrooms are governed by different requirements depending on the stage of production;  for example, between manufacturing and packaging. Most medical device manufacturing cleanrooms are required to comply with ISO 14644-1 Class 5-7, while medical device packaging is regulated by Class 7-8 standards. Also, while both phases are confronted with risks due to electrostatic discharge, it is most important to control static in the packaging phase, requiring more safeguards to dispel or conduct charges away from devices using ESD-safe equipment and materials. 

A segmented medical device cleanroom design could accommodate all of these requirements, by separating classifications within the same facility. Rather than running the entire space at the lowest possible classification, a segmented cleanroom would save significant energy costs, and be able to more efficiently prioritize operations according to each phase of medical device assembly.

Pharmaceutical Cleanrooms

Many pharmaceutical cleanrooms are designed using cascading pressure rooms with different pressure levels. In this system, each segment has a higher or lower pressure and a specific use to help protect contaminants from leaving one space and transferring to another where they could reduce the effectiveness of compounds, nullify test results, or even endanger human or animal life.

For example, the compounding area in a pharmaceutical cleanroom has different classification requirements and even a different pressure than the ante room attached to it. The purpose of the ante room is to allow the pressure difference to exist, and create a step down for employees to prepare before entering or after exiting the stringent segment. Segmented cleanrooms allow a single pharmaceutical cleanroom to house separate classifications in order to work with hazardous compounds safely and efficiently.

Medical Research Cleanrooms

Medical research cleanrooms may require an adjacent space for biosafe procedures or to house a negative pressure room. If the work involves sensitive or hazardous substances, a more rigorous classification and pressure will be required to isolate the work from external contamination or restrict contaminants from exiting the cleanroom. Segmented cleanrooms are used to allow these processes to occur within the same facility. An intuitive cleanroom design helps researchers focus on their work and feel safe within their environment. 

Interested in a unique cleanroom layout for your application? Get in touch with Angstrom Technology! Whether you want to create a segmented pharmaceutical cleanroom or upgrade your cleanroom classification, our experts can help you design, build, and install the ideal cleanroom for you. Reach out to us online today for a free quote.