Cleanroom classification is one of the most confusing – yet important – parts of designing and building your cleanroom. If you’re installing a cleanroom for the first time, you’re bound to have a lot of questions. Here are some answers to the most common cleanroom classification questions we receive.
1. What classification do I need?
It depends on your industry. The requirements will vary depending upon what size particles need to be filtered, the sources of contamination present, and recommended air change rate. If your industry is government regulated, you can check applicable regulation to see what classification is required. If there is no government-mandated or industry default classification, you’ll need to determine the appropriate classification, based on your application.
2. How are cleanrooms classified?
There are two different classification scales that are generally used, the U.S. General Service Administration standards (FS209E) and International Standards Organization (ISO) classifications. The classes are determined by the maximum acceptable numbers of particles (by size) in the air per cubic meter. See Cleanroom Classifications & Standards here.
3. How often do I need to test my cleanroom to see if it’s meeting classification requirements?
ISO requires that air pressure difference and air flow be tested every 12 months for all classifications. Particle count tests must be performed every 12 months ISO Class 6 and above, every six months for ISO Class 5 and below. There are also tests recommended for all classes, every 24 months: installed filter leakage, containment filter leakage, recovery, and airflow visualization. These tests are regulated by ISO document 14644-2 Cleanroom Testing and Compliance.
4. How often do I need to have my cleanroom inspected?
This depends on your classification. The more stringent classifications will require more regular inspection. Inspection may coincide with compliance testing, which, depending upon the cleanroom classification may occur every six or 12 months.
5. How does cleanroom classification affect my budget?
Essentially, the more stringent the classification, the greater the cost. Strict classifications will require more air, energy, advanced technology, and equipment. See How Does Cleanroom Classification Affect Your Cleanroom Budget? for a more detailed breakdown of the costs.
If you have more questions about your cleanroom classifications, check out our post What You Need to Know About Cleanroom Classifications, and make sure to give Angstrom a call! We’d love to help.
Pass-through chambers are an ideal addition to just about any cleanroom. They’re easy to install, they don’t draw much out of your budget, and they hold tons of benefits for the operation of your cleanroom. While there are all types of pass-through chambers, from basic transaction windows to industrial roll-up door pass-throughs, most cleanroom pass-throughs fall into the dual-door category. Because the removal of contaminants is any cleanroom’s top priority, most cleanroom pass-through chambers have two doors, one on the outside and one on the inside of the cleanroom. Those cleanrooms that must meet higher standards often install pass-throughs with additional features like an air shower or fire resistance, but the general construction and operation is the same.
What are the benefits of cleanroom pass-through chambers?
- They allow your employees to transfer materials in and out of your cleanroom without contamination.
- They make it easy for employees to pass materials into the cleanroom without having to gown. This also cuts down on the number of employees in your cleanroom at any one time.
- They come in a variety of sizes and materials, ensuring you get the pass-through that meets the needs of your employees. Stainless steel options are corrosion-free, which extends the life of your pass-through, and helps keep your cleanroom clean.
- Double door designs ensure cross contamination doesn’t happen. And heavy duty sealing lock features keep contaminants out of the chamber when it’s not in use.
- Most pass-through chambers are customizable, allowing you to choose the option that best fits the needs of your cleanroom. Whether you need a fire safe option, one that’s chemical resistant, or a pass-through chamber that includes a blower with HEPA filtered air, you can choose the chamber that best suits your cleanroom needs, ensuring you benefit from a pass-through chamber, regardless of your cleanroom classification.
How do cleanroom pass-through chambers increase productivity?
The single greatest benefit of a cleanroom pass-through chamber is its ability to speed up your processes and increase employee productivity. Pass-through chambers eliminate the need for employees to properly gown to enter a cleanroom environment just to hand off a necessary item or sample. As you likely know, the gowning process can be time-consuming, and additionally, the more employees you have in a cleanroom, the greater the chance for contamination. When employees can simply place materials in the pass-through chamber, you save a great deal of time on both sides of the cleanroom. Best of all, pass-through chambers are easily installed, whether you have an existing cleanroom or you’ve just commissioned a new one.
Who uses pass-through chambers?
The benefits of pass-through chambers are clear. They boost productivity without sacrificing cleanliness. So, which cleanroom industries use pass-through chambers, and how?
Because research facilities often study new and unpredictable chemicals and substances, they need pass-through chambers for safety more than for convenience. Because some chemicals can easily become volatile and cause fires, fire safe pass-throughs are commonly used in this application. These pass-through chambers can withstand fire exposure for up to 90 minutes, and their sturdy construction maintains frame shape that protects research labs from destruction. While these labs also often make use of air shower pass-throughs to decontaminate materials before they’re introduced to the lab, fire safe pass-throughs are the most common.
Medical and Pharmaceutical cleanrooms
Decontamination is the first priority of both medical and pharmaceutical cleanrooms. Because hospital laboratories often deal with highly contagious substances, it’s paramount that the environment remains sterile. In the same vein, pharmaceutical cleanrooms have to ensure there is absolutely no contamination in the manufacturing process that could alter their product. In both cases, these cleanrooms require pass-through chambers that keep samples, specimens, and other materials sterile as they’re brought into the cleanroom. These industries typically make use of a standard two door pass-through chamber that keeps outside contaminants from entering the cleanroom and ensures the materials remain sterile as they’re waiting to be brought in.
Electronic and technology manufacturing cleanrooms
Manufacturing facilities that put together the complex inner workings of technological devices like computers and smartphones require very strict cleanroom environments that filter out even the smallest particles of dust and other contaminants. Just one tiny particle settling on a single piece in the manufacturing environment could render a future hard drive useless. Many electronic and technology manufacturing cleanrooms opt for highly monitored pass-through windows in order to maintain the sterility necessary to produce quality electronic products while maintaining a high level of productivity.
Pass-through chambers are a highly useful component of any cleanroom. They help you ensure that you keep your processes moving, while maintaining the high standard of cleanliness within your cleanroom. If you’re installing a new cleanroom, or even if you’re considering adding a pass-through chamber to your existing cleanroom, be sure to give the experts at Angstrom Technology a call! We’ve been manufacturing top-of-the-line cleanrooms for years and would be more than happy to help you find the pass-through best for your operation. Call our office at 888-768-6900 or contact us online today!
No matter what company you work for or in what application you need a cleanroom, you have a budget. If you own your own company, you likely have to figure that budget out for yourself, and if you’re commissioning a cleanroom on the behalf of your employer, you’ve probably been given a budget that you need to stick to. One of the biggest factors that will determine that budget will be the cleanroom classification that your application has to comply with. For example, if you’re a medical device packaging company, your new cleanroom will have to meet an ISO 7 standard. These classifications differ based on industry and application and are defined based on the size and amount of particles allowed in an operational cleanroom. For a more in-depth look at how cleanroom classifications work, check out this page with a full chart on the requirements of each class.
It’s good to know that the classification of your cleanroom will definitely affect your budget in that the lower number classes, which are more restrictive and “cleaner,” are going to cost more than the higher number classes, say an ISO 8, which allows for a great deal of both small and large particulate. But how exactly does a more stringent cleanroom classification affect your budget, and in what specific ways will you see that when you get to the design phase?
It all starts with the three most important determining factors of each cleanroom class:
What size particles do you need to filter?
What sources of contamination you have?
What is the recommended air change rate for your cleanroom classification?
In understanding the answers to these three questions, it will be easier to see how cleanroom classification affects your company’s cleanroom budget. Let’s start with the size of particles:
Each cleanroom classification level allows for a certain amount and size of particles in an operational cleanroom. Some classes don’t allow larger sized particles in, but aren’t as concerned with the smaller particles. Other classes, like an ISO 1, require that almost all particulate, of all sizes, are kept out of the cleanroom. Now, the size of the particles you need to keep out of your cleanroom will affect which filters you buy, and some filters are more expensive than others.
Where a small ISO 5 cleanroom might only need one or two heavy duty HEPA or ULPA filters, an ISO 1 cleanroom of the same size could need a great deal more filters. Not only are you buying higher quality filters, at that point, you’re also buying considerably more. The size and amount of particles that are allowed in your cleanroom affect the quality of filters and other technology you’ll need, with the most general understanding being the higher the filtration requirements, the higher the overall cost for your cleanroom will be.
Sources of contamination
Sources of contamination most generally refer to where particulate can get into your cleanroom. So, how many doors, and how many windows does your cleanroom need? Do you have to build all the cleanroom walls initially, or are you installing a cleanroom within an existing building? All of these considerations relate to your cleanroom’s sources of contamination. Depending on the classification of your cleanroom, you’ll have different sources of contamination to watch out for.
For example, if your cleanroom needs an air lock or a pass through chamber to ensure that employees and sterile supplies can get in and out of the cleanroom without contamination, that will add on to your overall cost. On the other hand, if your cleanroom is configured to only need one or two doors, your cost is likely to be lower. This is one aspect of cleanroom classification that you have a bit more freedom to work within your budget, as you often have the option to choose how many entrances you want, as well as if you plan on installing an air lock or pass through chamber.
Air change rate
Perhaps the biggest draw on your budget out of these three considerations, the required air change rate in your cleanroom will either drive the cost of your cleanroom way up, or bring it way down. Each ISO class requires a different exchange rate, from 750 air changes per hour, all the way down to just 5 changes per hour. The lower the number of air changes per hour, the cheaper your cleanroom is going to be, simply based on the amount of work your heating and cooling system will have to do. If your cleanroom needs 750 air changes per hour, that means that you’re drawing considerably more energy at a fairly constant rate, which will drive your costs up. What’s more, an HVAC system with the ductwork necessary to facilitate that amount of air changes is also likely to cost you, unless you already have an adequate system installed.
The bottom line is, a cleanroom with a higher standard is likely to cost you more. Because cleanrooms with stricter requirements require more advanced technology and a great deal more air and therefore energy, your company will need a larger budget to accommodate those needs. That doesn’t mean that you can’t build the cleanroom you need though. There are all kinds of ways to choose design options that can lower your budget, and cut costs on luxury items you don’t really need.
If you’re worried about building a cleanroom that sticks to the budget you have, be sure to contact the experts at Angstrom Technology. We’ve been designing and building custom cleanrooms for over 25 years and will deliver the cleanroom you need, at the price you can afford. To chat with us about how to meet your budget and your deadline, give us a call at 888-768-6900, or contact us online today!
If you’re installing a cleanroom within your company for the first time, all of the information associated with the process can be a bit overwhelming. There are a whole variety of new terms, you have to decide where to put your cleanroom, how big to make it, how to do it all on budget, and what’s worse: you have to figure out what standards to adhere to. Cleanroom classifications are one of the most confusing parts of cleanroom construction. If it’s your first time commissioning one, it can almost seem like dealers are speaking another language, and no one makes it quite clear what a cleanroom classification really means. We thought we’d take a minute to explain what goes into cleanroom classifications and standards, so you have a better idea of what you’re working with when you get to commissioning your cleanroom design. Here’s everything you need to know about cleanroom classifications, from deciding what standard to adhere to, to figuring out how to do it cost-effectively:
What’s your application?
The very first thing to know about cleanroom standards is which one is required for your application. Every industry has different requirements and needs, from electronics manufacturing to food preparation, and some are more strict than others. It’s important that you know exactly which classification is required of your industry, because if you install a cleanroom that’s designed to the wrong specifications, you’ll either be spending too much money on an overpowered cleanroom, or your product will suffer from the excess contamination. If you’ve been contracting with a private firm for a while, or if your industry is regulated by a government agency, it’s a good idea to check with them to see what classification you should design your cleanroom for. They’ll have documentation on the standards their labs function to, and should be able to give you plenty of information regarding what’s necessary, what’s recommended, and what you don’t need to worry about when designing your own cleanroom.
What’s a cleanroom classification?
Cleanrooms are classified by the number of contaminants that exist in a functioning cleanroom. Contamination is measured in parts per cubic meter. Say, for example, that your cleanroom has to measure up to an ISO Class 6 level, which is rated at 35,200 parts per cubic meter. This means that within your cleanroom, you can have no more than 35,200 particles greater than .5 microns in size, per cubic meter of cleanroom space. For reference in size, the typical measurement for the end of a piece of human hair can be anywhere from 60 to 100 microns in size. A particle that’s as small as .5 microns in size cannot be seen by the human eye, which is why we need high-quality filters to contain them.
The current accepted standards for cleanroom classifications are ISO (International Standards Organization) standards. This is the classification system most widely accepted internationally, and the U.S. just switched to this standard officially in 2001. It’s likely that while you’re doing research on your new cleanroom, you’ll come across a classification called the Federal Standard 209E, which was the previous accepted American standard for cleanrooms. These federal standards were officially cancelled in 2001, but many people in the industry still reference them. It’s just important to know that in today’s world, your cleanroom will have to measure up to a certain ISO standard, rather than a federal one.
There are nine ISO classes: Class 1 (the cleanest) to Class 9. The lower the ISO class rating, the cleaner the environment. ISO standards created three new classes that the Federal Standard did not address, making it the more comprehensive classification system. It’s best to refer to ISO whenever possible, because it’s internationally recognized and will limit any confusion. Here’s a better look at what each ISO Class looks like, as well as how they measure up to the old Federal Standards:
|ISO 14644-1 Cleanroom Standards|
|Class||maximum particles / m3||FED STD 209E|
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5 µm||≥1 µm||≥5 µm|
|ISO 3||1,000||237||102||35||8.3||0.29||Class 1 Cleanroom|
|ISO 4||10,000||2,370||1,020||352||83||2.9||Class 10 Cleanroom|
|ISO 5||100,000||23,700||10,200||3,520||832||29||Class 100 Cleanroom|
|ISO 6||1.0×106||237,000||102,000||35,200||8,320||293||Class 1,000 Cleanroom|
|ISO 7||1.0×107||2.37×106||1,020,000||352,000||83,200||2,930||Class 10,000 Cleanroom|
|ISO 8||1.0×108||2.37×107||1.02×107||3,520,000||832,000||29,300||Class 100,000 Cleanroom|
|ISO 9||1.0×109||2.37×108||1.02×108||35,200,000||8,320,000||293,000||Room air|
(µm denotes micron particle size)
*Chart courtesy of PortaFab
Know how standards apply to your cleanroom’s 3 different states
So now you know what classification your cleanroom has to adhere to, it’s important to understand how that is measured by inspectors. Basically, your cleanroom has three different states: As built, at rest, and operational. The first refers to how your cleanroom performs just after it’s built–without furniture, employees, equipment, or machinery. Cleanroom certifications for cleanliness given by manufacturers refer to this as built state. At rest is your cleanroom once you have all of your equipment moved in, but before your processes are up and running. At this point, the workers have yet to move in, but your supplies and machinery are likely creating a bit of contamination just sitting in your room.
The third state refers to your cleanroom once you’re finally running processes with employees. This is going to change the level of contamination within the cleanroom the most, as people tend to shed a multitude of particulate, and machinery can often cause disruptions in airflow and give off contaminating fumes. It’s important to understand that once you get everything working, you’re going to have more particulate circulating your cleanroom than what your cleanroom standard calls for. Keep this in mind as you begin designing your ideal cleanroom, and make adjustments to allow for the extra particulate that will inevitably contaminate your cleanroom once you get people and machines moving.
Understand how a cleanroom works
Now that you know what the classifications are and how they’re measured, we’ll dive into how you get your cleanroom to meet those standards. To do that, it’s important to know how cleanrooms function. The great majority of cleanrooms exist on a positive pressure method. That means that air is pumped into the room through high-powered HEPA filters that remove the necessary contaminants. The air then flows down, and is pushed out through vents in the floor. The idea here is that any particles that exist in the cleanroom are forced out of the room by flowing air. Because positive pressure cleanrooms have higher air pressure than the rooms surrounding them, air flows from the cleanroom into the other rooms, which forces contaminated air from other rooms back, and away from the cleanroom.
In positive pressure clean rooms, air is constantly flowing out of the room. It’s good to know that negative pressure cleanrooms do exist, but they’re far less common. Negative pressure cleanrooms function exactly opposite of positive pressure cleanrooms, and are meant to contain dangerous contaminants like infectious diseases or hazardous substances. Air is pulled in from other rooms, is filtered within the cleanroom, and returns to the outside as clean, contaminant free air.
So how do you build a cleanroom that adheres to the proper classification?
In most cases, it all comes down to air. Most cleanrooms are structurally very similar: they feature return air grills, airtight walls, doors, and windows, and they basically function to keep clean air in, and contaminated air out. To achieve a cleaner class of cleanroom, it really all comes down to airflow. Any time you move down one class, you require about twice as much air. This is because the air is what does most of the work of ridding the space of contaminants. This is also the biggest cost associated with cleanrooms, because to get proper airflow in a cleaner class of cleanroom, you need more filters, more air return space, and generally just more air to be pumped into the space. The cleaner you need your environment to be, the greater the rate of air change.
|Class||Average Airflow Velocity||Air Changes/HR||Recommended|
|ISO Class 8||Not applicable||10-20||20 to 40|
|ISO Class 7||Not applicable||30-70||50 to 80|
|ISO Class 6||Not applicable||70-160||100-180|
|ISO Class 5||.2-.5 m/sec (40-90ft./min)||Not applicable||300-400|
|ISO CLass 4||.3-.5 m/sec (60-90ft./min)||Not applicable |
*Chart courtesy of Simplex Isolation Systems
For lower classes of cleanrooms, ISO class 9 through class 6, cleanliness is based on the amount of air changes that happen each hour. Cleanrooms that have more stringent cleanliness requirements–Classes 5 through 1–measure the flow of air through the room in meters per second. So how fast is that air moving through the room, how is it getting out, and when the air leaves the room, is it taking contaminants with it?
This is where a cleanroom designer comes in handy. Even if you create the perfect cleanroom with top-of-the-line technology, improperly placed equipment and furniture can create dead spaces where particulates are blocked from the air flowing through the room. When this happens, more particles are sticking around in your cleanroom, messing up your processes, and potentially hurting your workflow and production abilities.
We hope this blog helps shed a bit of light on the confusing world of cleanroom classifications! If you have more questions about designing your new cleanroom to the necessary standards, be sure to get in touch with the experts at Angstrom. We’ve been designing and installing cleanrooms across the country for years now, and would be happy to help you out! Request a free quote online today, or give our office a call at 888-768-6900.
Cleanrooms sound like something out of a science fiction movie. A bright white room where employees wear scrubs, booties, and hair nets? Seems a bit like Westworld. Though they may seem like odd, sterile environments, cleanrooms are absolutely essential to the future of technology and industry. Their high-tech capabilities make it possible to create an environment that’s as free from contaminants and air particulate as possible.
If you have a cleanroom, or are interested in installing one for your application, you probably already know what a cleanroom is, but what you might not know is just how common they are. In a way, they’re the unsung heroes behind technological advancement. Most people don’t know that cleanrooms are actually very widely used in a variety of applications. In fact, you probably have more than a few things in your home or even on your person that were made with the help of a cleanroom. Basically anything you can think of that requires precise manufacturing requires a cleanroom. In fact, some of the most common cleanroom applications might surprise:
Every photographer is looking to find the clearest lens on the market. From the consumer’s side, it’s just a matter of choosing a camera that’s well-reviewed and offers high resolution. But someone does have to make those crystal clear lenses that go inside of the camera. To make lenses and other optics pieces like smartphone cameras, a cleanroom is absolutely necessary. Cleanrooms ensure no particles are floating around in the manufacturing space that could dirty the lenses, and they control both temperature and humidity to create the perfect environment necessary for precise creation of optic parts.
Nanotechnology and electronics
The chips and nanochips that go into all of those technological devices we love so much, like our computers, laptops, smartphones, and tablets, are insanely small. These small pieces, however, hold and store tons and tons of data, and have to be 100% accurate for the rest of the machine to work properly. That’s where cleanrooms come in. The smallest speck of dust on the wrong part of a nanochip can render a computer ineffective, so it’s important that they be manufactured within a strictly monitored cleanroom. As nanotechnology continues to expand, cleanrooms have also become useful in recent green energy initiatives. Cleanrooms are now being set up to house nanotech solar cell production, a more cost-effective way to create widespread solar energy.
Whether they’re on a college campus or at a pharmaceutical company, research facilities are one of the most important ways to create innovation in science and medicine these days. Cleanrooms function as a controlled environment that allow scientists within research facilities to run multiple experiments and tests while being absolutely sure that outside variables are the same. Cleanrooms take out all of the guesswork that exists in uncontrolled environments and offer scientists the most accurate results possible. Without cleanrooms, scientists would have to complete experiments far more times, which lengthens the research process and slows innovation.
The aerospace industry is another realm you might not guess uses cleanrooms. Typically, when one thinks of aerospace engineering, the construction of a giant plane is what comes to mind. But actually, many of the tiny parts that planes need to fly, as well as very advanced spaceflight lasers, require absolute accuracy in production. Cleanrooms are the only way manufacturers can achieve this level of accuracy. The pieces that go together to form lasers that can vaporize space debris or charge the batteries of aerial vehicles are very tiny and can be rendered completely ineffective with just a little bit of contamination, making cleanrooms necessary.
The government is often at the forefront of technology, most typically in the military realm. Whether they’re developing new instruments to protect soldiers, or they’re working on more efficient ways to generate energy, much of the testing and research that goes into the development process must take place in a cleanroom for many of the same reasons as other industries: cleanrooms provide a completely controlled environment that does not change and is as free of particulate and contamination as possible.
As you can tell, cleanrooms are an integral part of future technology. Without cleanrooms, we wouldn’t have a variety of medications, we would be without accurate lab testing, and we wouldn’t be able to create some of the common technology we use every day. Cleanrooms provide the perfect environment to foster innovation, and they function to advance technology and create more perfect products.
If you’re looking to install a new cleanroom, or you think your existing cleanroom could use an update, get in touch with the experts at Angstrom Technology. We’ve been in charge of building and designing cleanrooms across the nation for years and would be glad to answer any questions you might have. Feel free to give our office a call at 888-768-6900, or contact us online at your convenience.