With the surge in popularity of electronic cigarettes, the need for regulation and standardization of e-cigarette and e-liquid manufacturing has emerged. In May 2016, the FDA issued a final rule which brought these products under its authority. In addition to regulatory compliance, cleanrooms for e-liquid manufacture allow for quality control and product consistency by providing a controlled environment free of harmful contamination.
The American E-liquid Manufacturing Association dictates a dedicated “lab/mixing space” and that manufacturing processes meet food preparation standards. (Click here to see the current AEMSA standards.) E-cigarette and e-liquid manufacturing is now regulated by the FDA, which is working to require that these products be manufactured within a controlled cleanroom environment. The necessary cleanroom classification is dependent upon the specific product and process, but e-liquid manufacturing would generally require cleanrooms to meet and be certified to ISO Class 7 or ISO Class 8 standards.
When it comes to installing a cleanroom for your e-liquid manufacturing business, sooner is better than later, especially with FDA legislation looming. Modular cleanrooms are one of the best options for e-liquid cleanrooms for a variety of reasons. Modular clean rooms have better lighting options than traditionally constructed spaces, as well as greater flexibility since modular cleanrooms can be easily reconfigured or expanded when your operation changes. They are often less expensive and time-consuming to install than traditional construction and offer greater flexibility when it comes to location and placement. Modular cleanrooms are essentially self-contained and can be placed nearly anywhere in your space for greatest efficiency and convenience, even in the middle of a large warehouse-type building.
Additionally, various parts of your process may require different levels of cleanroom control. Hardwall cleanrooms provide the highest level of control over contamination, humidity, and pressure, and are ideal for manufacturing activities and quality control testing; softwall cleanrooms can provide clean, contaminant-free space for e-liquid bulk storage.
As demand for e-liquid increases, so does consumer and regulatory scrutiny on its manufacture. Manufacturing e-liquids in a cleanroom environment is becoming a necessity, and ensuring that the cleanroom meets the industry ISO standard and your company’s needs is an important consideration.
Designing a cleanroom for your e-liquid company? Call Angstrom Technology. We have the experience and the technology to create the cleanroom you need.
If you have a cleanroom, are installing a cleanroom, or are considering whether your company needs a cleanroom, you already know why cleanrooms are important and necessary for your operations. You may not have considered, however, the type of cleanroom: a traditionally constructed space or a modular cleanroom. Modular cleanrooms have numerous benefits when compared to traditional construction, here are just a few:
Modular cleanrooms are free-standing
A free-standing cleanroom can be placed nearly anywhere, without extensive construction or renovation (and the costs and disruption those processes entail). If you have a free-standing modular cleanroom, you’re able to place it in the optimum location–whether that is the middle of a large open production floor or tucked back in a corner. You don’t need to build walls or change existing ones. Additionally, electricity and plumbing are already engineered into the cleanroom as part of the modular design.
Modular cleanrooms are quickly built
Building something from a kit, with the building materials included and the design already completed is always a simpler, easier, and quicker process than starting from scratch. Installing a modular cleanroom streamlines the building process–the design is complete, the materials selected and included, and construction simple and straightforward.
Just as modular cleanrooms are easy to assemble, they can also be easily disassembled, when compared to permanent construction. If you decide to move your cleanroom’s location within your facility or move it to a new facility, it can be quickly taken down and rebuilt in the new space.
Modular cleanrooms are easily modified or expanded
Should your company’s cleanroom needs ever change, modifying a modular cleanroom is much easier than renovating or remodeling a traditionally constructed space. Modular cleanroom walls are easily moved to accommodate a new cleanroom layout, and they can be expanded by adding additional wall pieces. You don’t need to start fresh with all new materials every time your cleanroom needs change.
A modular cleanroom can be a benefit for your company when you consider their flexibility, portability, and ease of installation and modification. Modular cleanrooms allow you to customize your cleanroom space to the ever-changing and evolving needs and capabilities of your company, and they are an excellent cleanroom solution that can save time and money.
Angstrom is a leader of the modular cleanroom industry. Whatever the size and classification of your project, we can design a cleanroom that fits your specifications. Contact us for more information.
If you’re working on putting together a design for your cleanroom, you’ve likely noticed that there isn’t a ton of helpful information out there. That’s because up until recently, most buyers just hired a contractor they felt they could trust, and left it at that. But if you’re here, it’s likely because you’re a part of the newer generation of buyer: the savvy, researching buyer who wants all the information before you even head to a cleanroom manufacturing pro.
Well, we’re here to help you out as best we can. We know it can be tough to find the info you’re looking for when it comes to cleanroom components, so we put together this blog to help you figure out your options for cleanroom walls. First things first, what are the most basic components you need for a successful cleanroom wall that upholds your application’s standards?
When it comes to cleanroom walls, you’re really looking for two things: smooth, dust-free surfaces. But finding the type of surface that’s perfect for your operation is a bit easier said than done. To determine what wall material type is best for you, there are a couple of considerations to keep in mind:
One of the biggest concerns for any new cleanroom, you need to decide how flexible your cleanroom should be. If you plan on housing it in the same building for a decade or more, then you can probably get by with cheaper wall options. Drywall coated with epoxy paint is, at first glance, the easiest way to go about cleanroom walls. You literally just take your building’s existing walls and paint them with an epoxy coating that’s rated for cleanrooms. The only problem with painted drywall is that those will be the walls you’re stuck with now and forever. When it comes to stick-built cleanrooms, there’s very little option for rearranging or expanding the space you started with.
If you think your cleanroom is likely to expand once business gets underway, then a modular cleanroom with moveable wall panels might be the better option. It’s true that the materials might cost a bit more upfront, but you’ll also want to consider what you’d be getting for that additional fee. Modular cleanroom wall panels are typically manufactured out of materials that are scratch and damage resistant. This is helpful because if something runs into one of your modular wall panels, you don’t have to worry about drywall particulate below an epoxy coating seeping out and contaminating your cleanroom. If a modular wall panel gets a scratch, there’s very little cause for concern, and in most cases, you can return to business as usual. Worst case scenario: if the damage is substantial, you can simply call for one replacement panel, which is easily fitted into your existing system in no time at all.
Once you’ve decided whether you’ll be going with fixed or modular cleanroom walls, it’s time to consider the cleaning agents you’ll be using on those walls. Every cleanroom classification is different and requires different levels of sterilization. Pharmaceutical cleanrooms, for example, have to be sterilized with very harsh chemicals multiple times a day. In this situation, you need a wall exterior material that can hold up to those chemicals without warping, corroding, or melting. Applications that use super-strong cleaning materials typically need walls made from stainless steel, which are then coated with a cleanroom specific paint or coating.
On the other side of the coin, if you plan on cleaning your cleanroom regularly, but don’t need to be using the highest grade cleaning supplies on the market, options like vinyl or fiberglass panels are a more cost effective choice. When you’re using lower grade cleaning materials, then you really just need a wall panel that’s going to prevent bacteria and particulate from sticking to it. You won’t have to worry about harsh chemicals eating through coatings and materials, and causing a lot of particulate buildup within your cleanroom.
As we mentioned before, durability can play a big role in your choice of cleanroom wall material. Depending on your application, you’ll need varying levels of material durability. Some materials, like lightweight vinyl modular wall panels, or epoxy coated drywall, can be easy to scratch. When the protective coatings of these types of walls are scratched, the material underneath is exposed and can give off dangerous particulate that can interfere with your processes.
What’s more, some wall materials just start to give off particulate as they age. For example, wood core wall panels are a fairly popular choice for many mid-class cleanrooms, because they’re very sturdy, affordable, and provide decent insulation. They’re an unacceptable choice for sub-Class 1 cleanrooms, however, because as wood ages, it gives off particulate in flakes and splinters. Cleanrooms with more intensive standards are typically best served by walls made primarily of aluminum structure. Aluminum is lightweight, durable, and best of all, doesn’t give off particulate as it ages. That said, it is a more costly option. So if your cleanroom doesn’t need quite that level of cleanliness, you might choose a less expensive option.
Perhaps the biggest consideration that goes into your cleanroom wall material decision, you have to stick to a certain budget. What’s different about cleanrooms is that most of the money you put into them goes into the airflow, the expensive filtration systems, and the energy you have to use to keep your cleanroom functioning properly. Because of this, a lot of cleanrooms don’t look as expensive as they actually are. Your cleanroom walls can be one of the least costly aspects of your cleanroom as they are relatively low-tech. If you’re looking for some area of the project where you can save money, this is certainly it. At the end of the day, most companies’ cleanroom wall choice comes down to cosmetic preference. There are so many options for cleanroom walls, from epoxy coated drywall and panels to vinyl and fiberglass panels, that you shouldn’t have to worry about spending a high percentage of your budget on walls.
That said, know that there are quite a few companies who do spend more on their walls because they want their cleanrooms to reflect the expense put into them. Many laboratories and manufacturers will opt to spend more money on say, stainless steel walls, even when they don’t need them because it gives their cleanroom the look of a high-tech, cutting-edge facility. Know that you don’t have to have these impressive walls to meet your cleanroom standards. If you have extra room in the budget and are looking to build a cleanroom that looks as impressive as the technology behind it, then more streamlined, shiny, expensive options are perfect for you. But you don’t have to go that route if you don’t have the budget.
Cleanroom walls are often overlooked when it comes to designing a new cleanroom. There’s not a lot of information out there about them, and it can be difficult to decide which material will work best for your application, and convey the image you’re looking for. If you have more questions about choosing the right wall material for your cleanroom, be sure to give the experts at Angstrom a call! We’re here to help you, and we’d love to provide you with any cleanroom information you’re looking for to make the best, informed choice for your company. Give our office a call at 888-768-6900, or request a quote online today!
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.
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!