EVERYTHING YOU NEED TO KNOW ABOUT CLEANROOMS
Everything You Need to Know About Cleanrooms
If you’re new to the world of cleanrooms, there’s quite a bit to know. From the industry jargon to the many different types of cleanrooms, it’s not always easy to jump into such a technical industry. Whether you’re starting your research into your company’s new cleanroom, or you have a few questions you’d like cleared up about cleanroom technology, this guide to cleanrooms has all of the answers you’re looking for. Use the Table of Contents below as a tool to jump to the section you’re most interested in, or just start reading to learn everything there is to know about cleanrooms.
TABLE OF CONTENTS
- What is a Cleanroom?
- What is a Modular Cleanroom?
- Benefits of a Modular Cleanroom
- Three Types of Modular Cleanrooms
- HardWall Cleanrooms
- SoftWall Cleanrooms
- RigidWall Cleanrooms
- Starting a Modular Cleanroom Project
- Step 1: Cleanroom Classification
- Step 2: Cleanroom Design
- Step 3: Cleanroom Installation
- Step 4: Cleanroom Maintenance & Service
- Who Needs a Cleanroom?
What is a Cleanroom? An Overview
A cleanroom is a controlled environment that is designed to remove pollutants like dust, airborne microbes, and aerosol particles. Pollutants are filtered out to provide the cleanest environment possible for a variety of applications, from manufacturing and pharmaceutical to scientific research.
How Clean is Clean?
Every cleanroom has a specific cleanliness level, which is quantified by how many particles exist in the room per cubic meter. We’ll talk more specifically about different cleanroom classifications later on, but it is good to know that every industry, and even every application, might require a different level of cleanliness.
How Long Have Cleanrooms Been Around?
Cleanrooms, as we know them today, didn’t really get their start until the early 1960s, when physicist Willis Whitfield invented a cleanroom with constant airflow that flushes out any harmful particles.
How Do Cleanrooms Work?
Cleanrooms make use of airflow and high-tech filters to rid the controlled environment of any particles that could contaminate the research, development, or manufacturing field. Cleanrooms make use of either negative or positive air pressure to control how clean the environment is.
A cleanroom with positive air pressure has clean, filtered air pumped into the environment, giving it more pressure than the rooms around it. If the door was opened to the cleanroom accidentally, clean air would be forced out of the cleanroom, blocking any unfiltered air from coming in.
A cleanroom with negative air pressure has a lower pressure than the rooms around it. This is achieved by filtering air out of the cleanroom, rather than pumping air in. Negative air pressure cleanrooms are used in cases where the goal is to keep contamination from escaping the environment.
For more information on negative and positive air pressure cleanrooms, check out this blog: What’s the Difference Between Positive and Negative Air Pressure Cleanrooms.
What is a Modular Cleanroom?
A modular cleanroom is a cleanroom made from pre-fabricated components. While modular cleanrooms can be as permanent as a cleanroom that’s built with stud and drywall, they’re easier and faster to build and are easily modified in the long-run.
The main difference between a modular cleanroom and a traditionally constructed cleanroom are the materials used, and the speed of the build. For these reasons among others, many companies in a variety of applications choose modular cleanrooms. Here are a few of the additional benefits of a modular cleanroom:
Benefits of a Modular Cleanroom
Modular cleanrooms are a popular build option for most industries. With all of the same features of a traditional cleanroom, modular cleanrooms are easily constructed in half the time, with greater flexibility and at considerably less cost. Here’s a breakdown of a few key benefits of a modular cleanroom:
Simple, Efficient Build
When you commission a modular cleanroom, the entire room is manufactured to your direct specifications, off-site. It’s then sent to you, where the entire kit is easily assembled with minimal tools and minimal time.
There’s no need to find a site, do any excavating, or construct walls. Every component of your cleanroom is sent to you, pre-fabricated. All that has to be done is put it together, or have an installation pro put it together for you in just a few days.
Build Anywhere, in Any Facility
One benefit that many modular cleanroom owners love, is that a modular cleanroom can be built anywhere — even in an existing facility. There’s no need to rent new space or break new ground. You can have a cleanroom designed in the middle of a large open production floor, or tucked back in your warehouse’s office space. Put your new modular cleanroom wherever you need it most.
Modify or Expand at Your Convenience
Since modular cleanrooms are made from pre-fabricated panels, they’re easy to modify. Make your cleanroom bigger, smaller, or take it down when your project is over and put it in storage until you need it again. Modular cleanroom components are lightweight and easy to move around, allowing you to reconfigure your cleanroom space for any new application or change in production.
To learn more about the many benefits of modular cleanrooms, take a look at this blog about the Benefits of Modular Cleanrooms.
Three Main Types of Modular Cleanrooms
Believe it or not, modular cleanrooms aren’t all the same. Depending on your application, you have a few choices for the material your cleanroom is made out of. There are three main types of modular cleanrooms: HardWall, SoftWall, and RigidWall. The difference in each is the type of material the walls are made out of. Let’s take a look at each:
HardWall cleanrooms are made out of solid material, like stainless steel, vinyl, plastic laminate, aluminum, or fiberglass reinforced plastic. Cleanrooms like these are best for applications that must comply with a high standard of cleanroom classification because they are the most secure, and the easiest to clean. A HardWall cleanroom can be engineered to comply with any standard, which makes it a versatile option.
HardWall cleanrooms are also preferred for their durability, simple installation, and easy modification. Since HardWall cleanrooms can be made to fit any standard, they’re great for companies who may be advancing their capabilities down the road. They’re easy to modify and upgrade, and they’re also very simple to maintain. If you have an expanding facility or need a cleanroom that can comply with very high standards, a HardWall cleanroom is likely the best choice for you.
SoftWall cleanrooms are, as the name suggests, much lighter than HardWall cleanrooms. SoftWall panels are constructed of a clear vinyl sheet and the framework comes in a standard white powder-baked enamel finish that makes them very easy to maintain. Capable of meeting Class 10 to Class 100,000 standards, SoftWall cleanrooms are often chosen for their extreme affordability, and for the fact that they can be installed just about anywhere. Choose to suspend a SoftWall cleanroom from an existing building or make it freestanding. Since SoftWall cleanrooms are so compact and customizable, they can be made to fit nearly any space.
Many companies choose a SoftWall cleanroom when they need a cleanroom that meets certain specifications, but doesn’t require the highest standards such as temperature or humidity control. Since they are so affordable and flexible, SoftWall cleanrooms are great for larger applications, and for custom cleanrooms that require unique features like an airlock or ULPA filters.
Not sure if a SoftWall or HardWall cleanroom is best for your application? Check out this article about HardWall Vs. SoftWall Cleanrooms, or keep reading to learn about the third type of cleanroom.
One of the most versatile cleanroom options on the market, RigidWall cleanrooms offer you the structure of a HardWall cleanroom with the visibility of a SoftWall cleanroom. Most sizes easily installed in 2-3 days, RigidWall cleanroom components are made from crystal-clear, accrylic, modular panels that look great and perform even better.
RigidWall cleanrooms can offer contamination security from Class 100 standards to Class 100,000 standards, which means they’re perfect for a variety of applications. Like other modular cleanroom material options, RigidWall cleanrooms are flexible, and can easily be modified or expanded to fit new processes and changing.
Starting a Modular Cleanroom Project
Now that you know what a modular cleanroom is, why companies use it, and some of the various modular cleanroom materials available, you’re probably ready to figure out how you can get a new modular cleanroom project started.
Whether you’re just considering installing a cleanroom, or you’ve already gotten approval, this next section will cover some of the key steps to getting started with a modular cleanroom project. First up: determining your cleanroom’s classification.
Step 1: Cleanroom Classification: What You Need to Know
Every cleanroom design starts with a specific standard or classification. While there are a few different classification scales (which we’ll get to next) the general purpose of determining your cleanroom’s classification is to see just how clean your cleanroom has to be. A cleanroom’s classification refers to the maximum acceptable number of particles (by size) in the air per cubic meter.
Here in the US, most industries rely on two classification scales, International Standards Organization (ISO) and the U.S. General Service Administration Standards (FS209E), to determine the cleanliness of any given cleanroom. You can take a look at the specific breakdowns of both of those classification scales on our Cleanroom Classifications & Standards page.
How Do I Know What Classification My Cleanroom Must Meet?
Typically, your industry will have specific guidelines for which classifications your cleanroom should meet, depending on your specific application. But, if you’re not sure what those requirements are, or where to look, here are a few questions that can get you started down the right path:
What Size Particles Do You Need to Filter Out?
The biggest question your classification standard can answer is what size particles you need filtered out. For example, if you’re working in nanotechnology or microelectronics, even the smallest particles can be detrimental to the performance of your products. You’ll need a higher cleanroom classification with the technology to keep tiny particles from interfering with your employees’ work.
If you’re working in a more traditional automotive manufacturing setting, you might just be worried about larger particles disrupting sensors and other key components. While you still need a cleanroom, you probably won’t need the same level of technology and filtration as someone in the nanotechnology field. Your cleanroom will likely fit a lower classification standard.
Where Are Contaminating Particles Coming From?
As you already know, cleanrooms work to keep contaminants out. They provide a safe, controlled environment for your products and processes, so you can manufacture and assemble without defects. Think about the contaminants your cleanroom will have to keep out. Where are they coming from?
The amount of contaminants in your environment, and where they’re getting into your cleanroom, can also affect the classification standard your cleanroom must meet.
How Much Air Do You Need to Keep Those Particles Out?
The final component of determining your cleanroom classification standard is how much air you’ll need to keep those particles out. ISO standards, which we mentioned above, actually come with a recommended number of air changes per hour.
This refers to how many times per hour the air in your cleanroom is exchanged for new, filtered, and clean outside air. A cleanroom can change air anywhere from 10 to over 600 times an hour, depending on the classification standard your cleanroom has to meet. The stricter your cleanroom’s standards, the more air changes your cleanroom will need per hour.
For more help determining what classification standards your cleanroom should meet, check out our Cleanroom Project Design Guide or this article What You Need to Know About Cleanroom Classifications. In most cases, your industry likely specifies the standards your cleanroom must meet for your application, but you might also consider taking a look at this bulleted list below for a general reference:
- Biotechnology — ISO Class 5 to ISO Class 8
- Pharmaceutical — ISO Class 5 to ISO Class 8
- Semiconductor — ISO Class 1 to ISO Class 6
- Optics — ISO Class 1 to ISO Class 6
- Defense — ISO Class 1 to ISO Class 6
- Medical Device — ISO Class 7 to ISO Class 8
- E-liquid and vaporizer — ISO Class 7 to ISO Class 8
- Nanotechnology and Microelectronic — ISO Class 1 to ISO Class 6
- Automotive — ISO Class 7 to ISO Class 8
- Manufacturing — ISO Class 7 to ISO Class 8
- Hospital — ISO Class 5
- Food — ISO Class 6
- Aerospace — ISO Class 5 to ISO Class 8
Step 2: Cleanroom Design
Once you know what classification standards your cleanroom needs to meet, you can get to the actual work of designing your cleanroom. For the most part, all cleanrooms function in much the same way. They either push clean, filtered air in, or pull filtered air out. Either way, there are three major factors that will affect how you design the perfect cleanroom for your application. Let’s take a look at each of those, to help you get a better feel for what your new cleanroom will look like.
Your budget is a key factor in your cleanroom design. We always recommend clients start with a budget upfront, so we know what we’re working with, and so we can design a cleanroom that meets your specifications, without going over your budget.
Looking to save a few pennies on that new cleanroom? Here are a couple of ways you can reduce the overall cost of your cleanroom:
- Opt for Shorter Ceilings — The bigger your space, the more air you’ll have to pump in to make sure you’re meeting the required air exchange rate for your cleanroom’s standards. And the more air you have to pump in, the higher your operating costs. A room with 10 foot ceilings, rather than 8 foot ceilings, is 25% larger, and almost none of that additional space is functional for your application. If you’re hoping to save a bit on the overall cost of your cleanroom, consider using only as much space as you need, as well as consulting with a cleanroom design and installation expert who has the experience to offer tips like this.
- Consider Starting Small and Growing with your Level of Business — Because modular cleanrooms are so easily expandable, you can grow the size of your room to match the size of your business. When initially installing a cleanroom, focus on your current needs, and rest assured that your modular cleanroom can be adjusted if a new customer or contract were to come in.
Want more help crunching the numbers? Check out this post: How to Determine Your Cleanroom Design Budget.
The size of your cleanroom is also something to know before you start designing. Think about how many employees you’ll need in the space, what equipment you’ll have to have, and any other considerations, like room for storage. Determining the size of your cleanroom will give your cleanroom design and installation professional an idea of:
- How many filters you’ll need
- What size HVAC system might be required
- How many wall panels your cleanroom will need
- How much lighting you’ll need
- What temperature and humidity concerns to keep in mind
It’s good to remember that when you’re designing a modular cleanroom, you should always design for your current needs. Modular cleanrooms are easily adapted to any changes that could happen in the future, so work to design your cleanroom to fit your current application. If you need to add on or take some space away in the future, that’s easily done thanks to modular cleanroom construction.
Deciding on the size and budget for your cleanroom will also make it easier for you to narrow down the perfect location.
If you have a smaller budget, and are looking at a smaller cleanroom, you might have the space for it in your existing building. Modular cleanrooms are easily constructed within buildings, and can be suspended from your building’s ceiling, and even potentially connected to your existing HVAC system.
If you’re working with a bit more money, you can also find an offsite location, or build your cleanroom as an expansion of your existing building.
Because modular cleanrooms are so flexible, the location of your new cleanroom project will depend primarily on what’s most convenient and affordable for you.
Key Components of Cleanroom Design
When you know the budget, size, and location for your new cleanroom, the real design work can begin. If you’re working with a cleanroom design and installation expert, this is the point where they’ll come out and perform an on-site inspection. This helps them get a better idea for your space, and better customize your cleanroom design to your unique application.
If you’re new to cleanroom design, here are a few of the key components you’ll want to make sure you consider in your cleanroom design:
Cleanroom flooring is an essential component working to keep your cleanroom particle-free. In general, most applications use either perforated raised flooring, seamless vinyl, or epoxy paint on concrete. Each of these three flooring material options ensure that no particles are trapped in cracks in the floor, and work to make cleaning as easy as possible.
Filters are likely to be one of the biggest investments you make in your cleanroom design project. There are also three types of filters used most often in cleanrooms:
- Prefilters — Used with both HEPA and ULPA filters, prefilters work to filter out the largest particles in the air. Essentially, they save the bigger, more expensive filters a little work, and ensure you get a bit more bang for your buck.
- HEPA Filters — The most commonly used cleanroom filter, HEPA filters (High-Efficiency Particulate Air filters) work to remove particles 0.3µm or larger. HEPA filters work to filter out 99.99 percent of those particles.
- ULPA Filters — ULPA (Ultra Low Particulate Air filters) are used in applications that require the removal of the smallest particles possible. They remove 99.999 percent of particles larger than 0.12µm.
If you’re new to cleanrooms, you may be surprised to learn how important lighting can be to the overall design of your cleanroom. It’s essential to efficient operations within your cleanroom, and it can also have an impact on the overall operating cost of your cleanroom. When designing your cleanroom, a cleanroom design and installation professional will determine how many fixtures you’ll need, where those fixtures should go, and how bright your lights will need to be for the best results. Then, you’ll be able to choose the type of lighting that works best for you, from fluorescent to incandescent to LED.
Not sure where to start with cleanroom lighting? Check out Cleanroom Lighting Options Explained.
And once you have the basics, like filters, flooring, and lighting, figured out, you’ll also want to think about any specialty components of your cleanroom’s design. It’s good to remember that any cleanroom’s greatest enemy is anyone entering or leaving. A well-designed cleanroom will function at its classification standard in perpetuity if no one ever opens the doors. These specialty components help your cleanroom protect against invading particles as your employees enter and exit the controlled environment:
Airlocks help prevent particles from entering your cleanroom when personnel enter or exit the controlled environment. If your cleanroom requires a high classification standard, or if you’re just looking for ways to boost the efficiency and cleanliness of a lower classification cleanroom, an airlock is a great tool. Learn everything you need to know about airlocks here.
While every cleanroom has a slightly different gowning process, if your employees need to wear special equipment while in the cleanroom, it’s a good idea to install a gowning room alongside your cleanroom. This provides a clean space for your employees to don their required personal protection equipment, and can help reduce the number of particles they track into your cleanroom. Here’s what you need to know to get started with gowning rooms, and teach your personnel proper gowning procedure.
Like an airlock, an air shower is an added barrier between your cleanroom and the outside world. Unlike an airlock, an air shower packs an extra punch. Air showers blow filtered air at your employees to “scrub” them of any particulates before they enter the cleanroom. While air showers are often required for higher classifications like ISO Classes 1 and 2, they’re a good idea for nearly any cleanroom, as they require your cleanroom system to do less work to keep the environment particulate-free. Here’s a bit more information about cleanroom air showers and their cost.
Pass-through chambers are an excellent addition to any cleanroom application that requires you pass materials in and out of the cleanroom on a frequent basis. Easily installed in existing cleanrooms as well as new designs, pass-through chambers make it much easier for your employees to do their work efficiently, without having to de-gown, exit the cleanroom, and then re-gown, just to pass material outside of the controlled environment.
How A Cleanroom Firm Can Help You Design The Right Cleanroom
After reading about all of the components that go into cleanroom design, you might be feeling a little overwhelmed. That’s where a cleanroom firm comes in. If you’re planning a cleanroom design and installation project, it’s helpful to have someone at your side who understands all of the many components of a cleanroom, and who can help you design a cleanroom that fits your classification standard, your space, and your budget.
That’s where Angstrom Technology comes in. As one of the most innovative cleanroom firms in the industry, we not only design and install cleanrooms, but we also supply cleanroom components and products, ensuring we can help you through every step of your project, from start to finish.
We’re very familiar with some of the most popular new cleanroom design trends, and we have the experience to help you avoid common cleanroom design problems. If you’re looking for a true partner to help design you an effective, affordable cleanroom, let’s talk.
Step 3: Cleanroom Installation
The cleanroom design stage is a rigorous process. It is certainly the longest step to developing a new cleanroom, and for good reason — once your modular cleanroom is completely designed, it can be shipped right to your door, where you can easily install it in days, and even just hours, depending on the materials you choose and the size of your cleanroom.
Installing A Modular Cleanroom
One of the key benefits of investing in a modular cleanroom is that it’s so easy to install and assemble. All of the components of a modular cleanroom are built to fit your unique site, perfectly, before they are shipped to you. Here are just a few of the benefits that come with installing a modular cleanroom:
- Prefabrication — The most obvious benefit of a modular cleanroom is that all of the components are prefabricated. That means they’re built to a standard size so that every component fits perfectly together. You don’t have to worry about how your equipment will fit in the cleanroom or if a pass-through chamber is the right size for your space. It is already designed and manufactured for your unique specifications.
- Easy Electrical — When you work with a reputable cleanroom firm, like Angstrom, your cleanroom’s wall panels will arrive pre-wired for quick connection when it’s time to install your cleanroom. That means you don’t need an electrician or specialty installation help, which speeds up your installation time.
- Structure to Fit Your Facility — Modular cleanrooms are designed and manufactured to fit your unique facility. Whether your cleanroom will be freestanding or built upon your facility’s existing walls, modular cleanrooms are designed with longevity and structure in mind. They won’t sag or shift over time, and they’re built to fit your space perfectly.
- Install in Hours or Days — Since every component of your cleanroom is prefabricated, then deconstructed and shipped to your facility in order, your team can easily install SoftWall cleanrooms in just a few hours, and HardWall or RigidWall Cleanrooms in as little as two to three days. This ensures your project is up and running in no time at all.
While installing a modular cleanroom can be done quickly and efficiently, it’s not the right choice for every company. If you don’t have a lot of manpower on site, or if your employees are already busy with their daily operations, you can opt to have your cleanroom professionally installed. Here at Angstrom Technology, we’re here to help you. That means if you need support getting your cleanroom up and running, we’re happy to send a team out to your facility to get the work done.
Step 4: Cleanroom Maintenance & Service
Maintaining your cleanroom is just as important as choosing the perfect design. While your cleanroom will work for you to keep contaminants and particles out, your team will also have to participate in regular cleaning and maintenance to ensure your cleanroom can do its job well. That’s where a quality cleanroom maintenance and service provider comes in.
Whether you have to comply with regular cleanroom validation, need to add on to your existing cleanroom, or are looking for some design reconfigurations to better suit your operations, it’s important to have an industry-leading cleanroom firm at your side to provide the maintenance, service, and supplies you need to keep your operations up and running. Here are just a few of the things Angstrom Technology offers our clients, to ensure their cleanrooms are always running at peak performance:
- Project-specific furnishings — Cleanrooms require unique furniture that sheds particles and contaminants. Angstrom Technology is proud to supply a complete line of customizable cleanroom furnishings suited to cleanrooms of any classification.
- On-site training — We’ll teach your team everything they need to know. From proper cleaning routines to gowning procedures, we’re here to help make sure your team knows how to keep your cleanroom clean.
- Testing Equipment — The best way to make sure your cleanroom is functioning to your standards? Quality testing equipment. We’ll make sure you have the right equipment, and we’ll help your team learn how to use it properly.
- Maintenance — If you ever have a problem with your cleanroom, we’re here to help. As a full-service cleanroom design and installation firm, we’re here for you from start to finish. That includes any problems you encounter down the road, too. Our service team is happy to help diagnose and solve any issues your cleanroom might have.
Cleanroom maintenance is important. Once your cleanroom is up and running, any problems can cause downtime, which costs you money. Make sure you have a reputable cleanroom firm at your side to address regular maintenance and any emergencies that might arise.
Who Needs A Cleanroom?
If you’ve stuck with us through this entire page, you know what a cleanroom is, what a modular cleanroom is, the three types of modular cleanrooms, how they work, and how to start designing the cleanroom for your next project. But who actually uses cleanrooms?
If you’re reading this, there’s a good chance you do. There are actually hundreds of cleanroom applications spread across many industries. Here’s a look at just a few of the industries Angstrom Technology serves, who use cleanrooms every day.
Cleanroom Industry Applications
The aerospace industry is constantly changing and growing as new technologies are produced and implemented. Aerospace cleanrooms are used to ensure the safe production of critical aerospace products.
Often called the backbone of America, the agriculture industry, both here and internationally, is essential to developing the seeds and plants that feed the world. Agriculture cleanrooms are used to research seeds, pesticides, and feed, as well as to grow plants without pests or contamination.
Automotive industry advances help connect our world through thoughtful and sustainable transportation. Automotive cleanrooms are used to test for quality assurance, as well as for performance testing of paints and finishes.
Biotech cleanrooms must perform to the very highest classification standards to ensure quality testing and to protect employees. Cleanrooms used in this industry provide the controlled environment that researchers need to collect reliable scientific data.
Chemical cleanrooms are used by a variety of industries. Any process or application that makes use of hazardous chemicals or that tests specific chemicals needs a highly-controlled environment to protect personnel and exterior environments from any hazardous exposure. Chemical cleanrooms can also be used for chemical storage.
The environmental testing industry is burgeoning as citizens become more conscious of the impact our cities and manufacturing processes have on the environment. Environmental testing cleanrooms are ideal for in-depth analysis of wastewater, surface water, drinking water, sediment, hazardous waste, and more. These cleanrooms are helping us better understand what’s in our environment, and how it affects our lives and the world around us.
Food manufacturing cleanrooms are essential to ensuring the quality, safety, and integrity of products in the food industry. Since manufactured food products must adhere to FDA standards and requirements, food manufacturing cleanrooms are necessary to providing the accurate data that ensures these standards are met.
Forensic science cleanrooms must adhere to some of the highest cleanroom classifications to ensure accurate, reliable forensic analysis and data. Angstrom Technology provides both HardWall and RigidWall cleanroom options that meet forensic science cleanroom classification requirements.
Hospital laboratories, hospital pharmacies, and hospital pharmacies themselves all use hospital cleanrooms to protect patient’s health, and to offer efficient, accurate test results. Hospital cleanrooms are often used to protect patients with compromised immune systems, in addition to the testing and research applications of hospital labs and pharmacies.
The manufacturing industry relies on precise part and product manufacturing to develop more sophisticated products and manufacturing devices. Manufacturing cleanrooms offer the control over contamination, pressure, temperature, and humidity that is necessary to develop and test products with exceptional accuracy.
Medical devices work to keep patients alive. To do so, they need to be perfectly sterile, and manufactured to precise quality standards. Medical device cleanrooms offer the controlled environment necessary to develop medical devices that are sterile, functional, and that will work to make someone’s life better.
Medical Marijuana Grow Rooms
As the medical marijuana industry grows and begins to spread, state by state, across the country, so too do the industry’s regulations. Medical marijuana grow rooms offer the environment growers need not only to produce plants more efficiently, but also to meet industry standards for low levels of contamination.
Medical research cleanrooms are often seen in medical research laboratories working to discover new advances in fields like blood and stem cell research. Most often, these cleanrooms must meet some of the most stringent requirements to ensure total control over the research environment.
The microbiology industries studies some of the smallest organisms on the planet. These applications require specific, technological equipment, and microbiology cleanrooms that ensure only the microorganisms that are being studied are in the room.
Particle contamination presents severe complications to the production of microprocessors. Microprocessor cleanrooms work to keep these contaminants out, and to control conditions like humidity, static, and out-gassing to ensure that microprocessors are made safely and to product standards.
The pharmaceutical industry must meet heavy government regulations, put in place to keep people safe. Pharmaceutical cleanrooms are designed to meet those stringent standards and requirements. Choose from either HardWall or RigidWall cleanrooms to design a pharmaceutical cleanroom perfect for your specific application.
Plastic Injection Molding
No matter what industry, plastic molding injection requires critical quality assurance. Whether you’re working in plastic injection molding for the automotive, aerospace, or medical device industry, a plastic injection molding cleanroom offers the environment control you need to meet strict quality assurances.
Semiconductor cleanrooms are essential to the manufacture and packaging of semiconductors and microelectronics. Even small sources of contamination can cause major production issues and project failure, which is why cleanrooms with high classification standards are necessary to the semiconductor industry.
Cleanrooms aren’t just used for manufacturing and research. Some products, chemicals, pharmaceuticals, and more require controlled environment storage. Storage cleanrooms work to provide those products with a controlled environment that protects their quality.
Safe drinking water is a vital part of life. Every time you turn on your faucet, a water treatment facility has worked to provide you with the water that pours out. Water treatment cleanrooms are essential to the everyday operations of water treatment facilities providing safe, public drinking water.
While that might seem like quite a few cleanroom applications, that’s just the tip of the iceberg. Cleanrooms are used for hundreds of applications in different industries across the world. Here at Angstrom Technology, we’re proud to design and install custom cleanrooms for many of those industries and applications. We hope this cleanroom guide offered up the answers you were looking for about cleanrooms and how they work. If you have more questions about cleanrooms, their design, installation, or maintenance & service, we hope you’ll get in touch! Our customers are always our first priority, and we’d love to help in any way we can.
DISCOVER WHICH CLEANROOM IS RIGHT FOR YOU!
Federal 209E Standards
Prior to 2001, Federal 209E Standards were widely used to categorize cleanrooms into Classes 1-100,000. Although this system was replaced by ISO Classes 1-9, which encompass a broader range of classifications previously excluded by the old system, the FS209E nomenclature still exists in some industries as a familiar reference. See the chart above for the comparison between ISO classes and FS209E equivalents.
Other Cleanroom Standards
Some cleanroom applications must comply with special standards that are uniquely tailored to the threats facing their products and processes. Additional standards or industry requirements provide an extra level of protection, limiting allowed contaminants within controlled cleanroom spaces or specifying cleanroom layouts, safe operating practices, or cleaning procedures. These standards work to protect the products developed in cleanrooms and the people working to create them. A few examples of additional cleanroom standards are USP, ASTM and GMP.
US Pharmacopeia (USP) has a set of standards used to regulate cleanrooms developing, manufacturing, and packaging pharmaceutical products either for use in human or animal treatments. Most pharmaceutical cleanrooms must abide by USP 795, 797, or 800 standards.
- USP 795: non-sterile pharmaceutical compounds
- USP 797: sterile non-hazardous compounds
- USP 800: sterile hazardous compounds
USP Standards exist to ensure product strength, quality, and purity so that all compounds are certified to be high quality, safe to use, and effective as a treatment or therapy.
ASTM International Standards
American Society for Testing and Materials International (ASTM) develops technical standards for many different industries from manufacturing to consumer product safety, some of which use cleanrooms to develop, test, manufacture, or package products. Three major cleanroom applications that subscribe to ASTM standards are automotive cleanrooms, aerospace cleanrooms, and plastics manufacturing cleanrooms.
ASTM standards are used to regulate a number of products, substances, and processes, including metal, rubber, construction materials, petroleum, textiles, solar technology, medical products and devices, nanotechnology, additive manufacturing, and industrial biotechnology, to name just a few examples.
GMP and CGMP Regulations
Good Manufacturing Practice, or GMP, regulations ensure product consistency and quality, specifically when applied to food, drugs, medical devices and products, and also blood. GMP covers topics from materials used in handling and production to employee training, facility requirements, and hygiene practices. The purpose of GMP regulations is to make sure all products are effective, pure, safe, and free of contamination. Products that are certified GMP promise high quality and safety throughout their lifetime.
GMP regulations are outlined by the US Food and Drug Administration and are backed by the power of FDA laws. They are particularly important in medical cleanrooms, including medical research, pharmaceutical cleanrooms, and medical device manufacturing, but also for food production and biosafe cleanrooms.
CGMP, or current Good Manufacturing Practices, refers to the current, up-to-date practices businesses must follow. GMP regulations are often revised and it is the responsibility of the business to make sure its facilities and staff are updated accordingly.