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.
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.
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.
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!