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:
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.
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.
When you’re commissioning a new cleanroom, it can feel like a necessary evil. You need a cleanroom to start operations, but it costs a lot of money that you might not have available in the budget at the time. It’s a bit of a Catch-22. At this point, you’re probably looking for anything that will get you the cleanroom you need in the time frame you have. Luckily, there are a variety of design options that can solve some of the most common budget concerns. Here are a few cost-cutting design options to keep in mind when you’re looking for a cleanroom now:
One of the absolute quickest and easiest ways to save money on a cleanroom design is to opt for a modular cleanroom over a traditional cleanroom. In most cases, this is a perfectly valid solution, as modular cleanrooms can perform to almost all of the highest cleanroom standards. Additionally, modular cleanrooms can be modified to accommodate business expansions. And most importantly, they’re cheaper and quicker to build than your traditional cleanroom. When you opt for a modular cleanroom, you can get the cleanroom you can afford now without barring yourself from expanding to the larger cleanroom you really want in the future. If budget is an issue, modular cleanrooms are the way to save.
Make it Smaller
Sure, you want a cleanroom that’s big enough to handle the processes you plan on implementing in the future, but can you get by with something smaller for the time being? In the case of modular cleanrooms, there’s a lot you can do to get by with a smaller cleanroom. For example, you can use an existing wall and build your modular cleanroom off of that, which will reduce building and material costs. Remember, you can always build off of that existing cleanroom, or move it to a larger space down the road.
Additionally, by choosing a cleanroom design with a lower ceiling, you’ll also save money when it comes to energy and material costs. The smaller your cleanroom is, the less money it will cost to run it, and the less energy you’ll need to keep it to your ISO standard. If you can get by with a cleanroom with a lower ceiling and a more conservative size, and you need a cleanroom right now, then it’s not a bad idea to start small and expand later on. It’s good to note, though, that if you plan on expanding, to make sure you tell your cleanroom expert. They’ll be able to walk you through the best way to construct a cleanroom that works for you now, but will be compatible with additional processes when you do expand in the future.
Consider LED lighting
Cleanroom lighting makes up a large portion of the money spent on maintaining a cleanroom. Cleanrooms often require super-bright lighting options. While these lights are great at keeping the room well lit for employees, they’re often responsible for adding a surprising amount of additional heat to a cleanroom. This forces your AC unit to work even harder, which results in a spike in overall energy costs.
Today, there are a variety of LED cleanroom lighting options on the market that solve this problem. You can choose from a standard panel style to a strip style LED light that adheres to directly to the ceiling grid, without interfering with your cleanrooms’ laminar flow. LED lights produce little to no additional heat, and have an exceptionally long life, ensuring that you don’t have to constantly replace light bulbs and keeping your cleanroom cool.
Use your existing AC unit
Another great way to save money is to design a cleanroom that will function on your building’s existing HVAC or heating and cooling unit. This is an efficient way to control the temperature of your cleanroom, so long as your building’s unit can handle the extra load that your new cleanroom will add. Consult with your building’s heating and cooling expert to ensure the unit can handle that much energy, and if it can, you’re in luck!
It is good to note that some cleanroom class standards do require a cleanroom have its own AC module, in case the central unit fails. In this case, or in the case that your central unit is already overworked, you’ll need to ensure your cleanroom is properly ventilated to the outside. Though it’s usually cheaper to ventilate a cleanroom into the larger building, this puts a lot of additional stress on both your cleanrooms AC unit and the HVAC unit in the building. Avoid this if possible, to keep both units working in top condition for their intended lifespan.
We get a lot of questions from clients wondering if pre-filters are an acceptable option to use in conjunction with heavy duty HEPA and ULPA filters. The answer is definitely yes! Pre-filters are put in front of the larger filters and can be up to 80% efficient at capturing larger dust particles before they reach the HEPA and ULPA filters. This keeps your larger, more important filters cleaner for longer. Pre-filters are relatively inexpensive and easily cleaned and reused. By using pre-filters in addition to your HEPA or ULPA filters, you extend those more expensive filters’ lifetime and save yourself quite a bit of money.
Pass-thru chambers are another sneaky way to save money on your cleanroom. They’re a lot smaller than an access door, and they allow employees to transfer supplies or materials without having to gown up. This saves both money and time: money because in using a pass-thru chamber instead of a full door, you eliminate the possibility of contamination from foot-traffic and maintain a stable pressure during the interaction; and time because your employees won’t have to properly gown up to enter the cleanroom via the access door. In installing a pass-thru chamber as part of your new cleanroom design, you’ll save money by lowering energy costs and increasing employee productivity.
We hope that this list helps you find a cleanroom that works both for your application and your budget. If you have more questions regarding a cleanroom design that works for you, make sure to give the experts at Angstrom a call! We’re always here to help answer any cleanroom questions you can throw at us, so get in touch with our office at 888-768-6900, or request a cleanroom quote online today!
Cleaning a cleanroom seems a bit counterproductive, doesn’t it? By name, a cleanroom is already supposed to be clean, so what would the point of actually sterilizing it be? Unfortunately, no cleanroom, regardless of its ISO standard, is 100% effective. By having people move about in the cleanroom, particles are bound to fall and contaminate your cleanroom from time to time. That’s why it’s important to ensure that you and your employees are regularly cleaning your cleanroom. If you’re new to cleanrooms, there are a few methods you can use, as well as a few precautions to keep in mind. We’ll start with standard cleanroom sterilization methods:
For regular, routine cleaning, dry cleaning – or dry transfer – is the most common method of sterilization. This type of cleaning refers to the polishing or wiping of a surface with an absorbent or collective cloth. There are a variety of cleanroom-approved materials well-suited to this sort of sterilization, but the one you choose will depend on your cleanroom’s class. At the very least, you’ll want to ensure that whatever wipes you choose for routine dry transfer cleanings are lint-free. This will decrease the amount of lint and particles left behind from the dry transfer cleanroom sterilization. Dry transfer is commonly used on a daily basis to remove the minimal amount of particulate buildup that occurs in a short period of time.
Wet cleaning, the process of cleaning with an approved solution or cleaning fluid, is necessary when a standard dry transfer cannot remove the particulate that’s accumulated over a period of time – generally once a week. There are a variety of cleaning solutions suited to removing cleanroom particulate, but the one you choose for your cleanroom will depend on the surfaces you’re cleaning as well as the class rating of your cleanroom. It’s important to note that you’ll want to choose a product that’s approved by the EPA and is suitable for use in a cleanroom. EPA-approved products are often safer for your employees, as they emit less toxic fumes.
Instating Your Cleaning Process
Before you begin assigning employees to sterilize your cleanroom, you’ll first need to take a few initial organizational steps:
Standard Operating Procedure
You’ll need a clear, outlined procedure for each type of cleanroom sterilization process you plan on implementing: daily, weekly, and monthly. This procedure will ensure that every employee knows exactly what they’re responsible for at each cleaning. Your SOPs should include proper dilution techniques for any cleaning solutions used and should give an outline of which order employees should clean surfaces and appliances.
After creating the necessary SOPs, it’s time to train the employees who will be responsible for sterilizing the cleanroom. It’s a good idea to have a few designated employees who will always handle the cleaning. This ensures that the process is completed consistently each time. Employees should know exactly what to do from the point of entering the cleanroom with sterilized cleaning products and equipment to discarding of any waste after the cleaning is complete. By training and regularly observing the employees responsible for sterilization, you’ll be better able to ensure that your cleanroom is always cleaned properly.
Additional Cleanroom Sterilization Tips
Clean From Top to Bottom
No matter what sterilization process you’re using, it’s important that employees always clean from top to bottom. In a thorough monthly cleaning, this means that employees should start with the ceiling, move to walls, and then tackle surfaces like tables and chairs, saving the floor for the absolute last. In cleaning the area from least contaminated sections to the dirtiest, you will ensure that minimal particulate is left behind.
Many cleanrooms utilize sticky flooring to minimize the amount of particulate released into the cleanroom via shoes and dirt that collects on the floor. This is a great way to keep your cleanroom as sterile as possible, but it will require a different cleaning procedure. Ensure that your Standard Operating Procedure includes proper manufacturer instructions on the cleaning process for this sticky flooring.
Preparation of Cleaning Materials
It is paramount that employees follow proper preparation procedure for cleaning materials. In many cases, cleaning solutions must be diluted with water before they can be safely used on cleanroom surfaces. Improper dilution can result in 1) ineffective cleaning processes if there is too much dilution, and 2) the erosion and damage of cleanroom surfaces if solutions are not fully diluted. Most cleanroom sterilization products are caustic and require an adequate amount of dilution to ensure that they are removing only the particles that contaminate your cleanroom, and not corroding cleanroom surfaces. You’ll also want to double check that the cleaning materials you choose are suited to the surfaces within your cleanroom.
Beware of Fumes
Cleaning materials can cause a buildup of fumes, which contaminates your cleanroom and can be harmful to employees. To avoid fume buildup, ensure that fans and filter units are always left on during the cleanroom sterilization process.
Disinfect Cleaning Equipment
To protect from bringing in additional contaminants, it’s important to disinfect all cleaning equipment before it enters the cleanroom. This includes replacing old or disintegrating mop brushes and using new, uncontaminated cloths and wipes.
Follow Proper Gowning Procedure
In sterilizing the cleanroom, staff must follow standard gowning procedure. They should also treat cleaning as they would any other normal cleanroom operation. This means slow, controlled movements that limit the introduction or disturbance of contaminants.
With these basic sterilization tips, you can ensure that your cleanroom is always performing at its best by protecting your procedures, and reducing any possible contaminants in the area. Make sure you’re following a regular cleaning schedule, and keep your employees up to date if you ever make changes or adjust your cleaning SOPs. And if you have any other questions about sterilizing your cleanroom, give the experts at Angstrom a call. We’re always happy to help! Contact our office by phone at 888-768-6900, or request a quote online today.
An air shower is designed to function as a sort of gateway controller between your cleanroom and the rest of the world. When used properly, an air shower can cut down on a vast majority of potential contaminants and helps ensure that your product remains safe and uncontaminated. Today, air showers have become relatively commonplace because of their benefits, and comparatively small price. So what’s the deal with cleanroom air showers, and why does your cleanroom need one?
How Does a Cleanroom Air Shower Work?
Well, first let’s start with how a cleanroom air shower works. Essentially, it functions as a high velocity, low pressure, self-contained system. To clarify terms, the air shower is the actual high-velocity airflow fan that turns on once the employee is in the room, and the room itself, with dual locking doors, is called the air lock. For the sake of brevity, we will refer to the system as a whole as an air shower.
In a one-person air shower, the airlock has two doors that cannot be opened at the same time. The employee enters the room from the outside, the doors lock, and then the air shower begins blowing air in what we call a “flapping manner,” or high-velocity streams. These streams of air effectively “scrub” the employee of any lingering particulate, blowing them to the low-pressure side of the room. Typically, an employee will be cleaned for 4 to 8 seconds, and then will wait for an additional 2-4 seconds for the room to be purged of the contaminants. The second door, leading to the actual cleanroom, will then be unlocked, allowing the employee contaminant free entry into the production area.
Most smaller cleanrooms equipped with an air shower simply implement a one-person air shower, but cleanroom air showers do exist for many employees at once. These larger air showers are built kind of like tunnels and are beneficial for operations that have a shift change of 30-40 employees at a time.
Why Do You Need a Cleanroom Air Shower?
Well, if you think about it, why wouldn’t you? A cleanroom air shower provides your product and your employees with an extra layer of protection from any harmful contaminants or particles that could make their way into your cleanroom. One instance of too much particulate can result in a ruined batch of pharmaceuticals or a malfunctioning piece of electrical equipment. An air shower functions to prevent these major issues from happening. They’re also a helpful reminder to employees about the importance of remaining particulate-free. And on the off chance that an employee wasn’t as careful as they should have been when donning a gown, an air shower will help ensure that any extra particulate is scrubbed off before they enter a contaminant-free space.
Is a Cleanroom Air Shower Worth the Cost?
It always comes down to the bottom line. Clearly, air showers are effective, but are they worth the additional cost? Well, believe it or not, an air shower actually adds up to just a tiny percentage of an overall cleanroom installation fee. Compared to the rest of the cleanroom that you’re paying for, the cost of a cleanroom air shower is simply minuscule. Add that to the fact that if an air shower prevents even one contamination of a pharmaceutical batch, you’re saving way more than the air shower even cost you, making its price a very small concern. If you’re in the following applications, an air shower can save you big bucks in mistakes and contaminated product:
In addition to the money an air shower saves you in product consistency, cleanroom air showers have also proven to increase cleanroom efficiency, and lower the amount of particulate buildup within the cleanroom itself. Since the air shower is ensuring that as much particulate as possible is eliminated before anyone enters the cleanroom, less particulate buildup occurs over time. This means that a cleanroom with an air shower will require less maintenance than a cleanroom without. It also means that a cleanroom with an air shower will put less stress on HEPA filters–making them more efficient–since they won’t have to work as hard with additional particulate and contaminants.
No matter the cleanroom application, an air shower is guaranteed to decrease particulate and the presence of contaminants. And when it costs just a fraction of the price of your cleanroom itself, it’s a practical addition to your project. If you have more questions about cleanrooms, or if you’re considering adding an air shower to your new or existing cleanroom project, make sure to give the experts at Angstrom a call! We’d love to answer any questions or help you design a cleanroom that’s perfect for your application, your space, and your budget. Call our office at 888-768-6900 or submit a free request for a cleanroom quote online today!
And if you’re looking for more information on cleanroom design, or you’re hoping to get started on your new cleanroom construction project, make sure to check out our Cleanroom Project Design Guide below!