Cleanroom Terminology 101

Cleanroom Terminology 101

If you’re new to cleanrooms, the terminology surrounding them might seem like a foreign language, but it’s crucial to understand in order to design and run an effective cleanroom. Here’s a run-down on the most basic terms you need to know when it comes to cleanroom terminology.

What’s a cleanroom?

A cleanroom is a controlled environment that limits contamination and particles, as well as temperature, humidity, static, and other factors, in some cases. Specialized air circulation and filtration systems filter out particles and contaminants from the air. Cleanrooms can be used in a variety of industries and for a variety of applications, including storage, manufacturing, and testing and analysis. Read more about the various types of cleanrooms here.

What’s classification?

Cleanroom classification is a way of identifying the level of contamination control within a cleanroom. The classes are defined by the number of particles of certain sizes that are present in a cubic foot of air within the cleanroom. Cleanrooms are usually classified to either the ISO standard or Federal Standard 209E. Read more about cleanroom classifications here.

What’s ISO?

ISO stands for International Organization for Standardization, which is an international scientific body that creates standards for organizations for manufacturing, organizational success, and workplace conditions, among other things. ISO has created a standard for cleanroom classification that classifies cleanrooms into eight classes. Read more about the cleanroom ISO standards here.

What’s certification?

Certification is a process of testing and verifying cleanroom environmental controls to ensure that they meet the standard required for the industry and the application. This includes testing of the major components including filters, air flow equipment, HVAC, ionization equipment, etc. Read more about cleanroom certification and validation here.

 

Need to learn more about cleanrooms or need help designing one? Contact the cleanroom experts at Angstrom Technology. For more on cleanroom terminology, check out our cleanroom glossary.

What Is A Cleanroom?

What Is A Cleanroom?

The term “cleanroom” is a seemingly simple one: a room that’s clean. But it’s actually more complicated than that. Cleanrooms are specialized environments that are necessary for sensitive processes and operations, requiring careful planning and consideration, as well as specialized equipment and construction. So what exactly is a cleanroom?

What is a cleanroom?

A cleanroom is a controlled environment that is regulated to certain standards specific to the application, for the purpose of preventing contamination of a process or product. This generally includes controlling the amount of particulate matter in the air, which involves air filtration, control of air entering the cleanroom, and special clothing and other equipment worn by people inside the cleanroom, such as sterile gowns and gloves.

Who uses cleanrooms?

Cleanrooms are used in a variety of industries, including (but certainly not limited to) aerospace manufacturing, medical device manufacturing, semiconductor manufacturing, water treatment, food preparation and manufacturing, medical marijuana grow rooms, biotech manufacturing, e-cigarette and e-liquid manufacturing, pharmaceuticals, industrial manufacturing, and hospitals. The industry and cleanroom purpose (clean storage, process control, manufacturing, quality testing, etc.) determine the cleanroom standard that is used to control the environment.

What are cleanroom standards and classifications?

Cleanroom standards define the amount of particulate contamination that is allowable in a cleanroom space for each particle size. Cleanroom classifications use these standards to classify cleanrooms and measure them for compliance. There are two classification systems that are generally used, categories in which overlap. One is the ISO Classification system, which has eight categories ranging from least strict (ISO Class 8) to most strict (ISO Class 1). The other is the Federal Standard 209E (Fed-Std 209E) which ranges from Class 1 (most controlled) to Class 100,000 (least controlled).

Read more on cleanroom classifications and standards here.

No matter what your application or cleanroom needs, Angstrom Technology can design the perfect cleanroom for you.

When Is It Time for a New Cleanroom?

When Is It Time for a New Cleanroom?

If you have a cleanroom or laboratory space, chances are it cost your company a great deal of money to construct and get into working order. Because of that investment, you want to get the most mileage out of your cleanroom. But you shouldn’t put off updating or redesigning your cleanroom, especially when it’s integrity and functionality are crucial to your processes and operations. Here’s when you know it’s time for a new cleanroom:

When your application changes

If you’ve been using your cleanroom space for one purpose and your product offerings or processes have changed, you may need to redesign your cleanroom to meet your new process needs. For example, if you have a softwall cleanroom that you use for clean storage of e-liquid for e-cigarettes, but you now need a controlled environment in which to manufacture and test your e-liquid products, you’ll need a new cleanroom that can provide a higher level of environmental control and can accommodate the larger space you’ll need for workstations and equipment.

When your current cleanroom doesn’t meet your needs

If your cleanroom doesn’t meet your needs for your current application, even if your application hasn’t changed, don’t make do, upgrade. If your cleanroom doesn’t offer the level of environmental control that you need, have enough space, or accommodate the equipment you need for your process, it’s time to go in for a cleanroom redesign.

When you need more space

When people are bumping into each other in your cleanroom on a regular basis, having to share cramped workspaces, or waiting in line to use the fume hood, you need more space in your cleanroom. This could mean building an entirely new cleanroom, if your cleanroom is traditionally constructed, or expanding your cleanroom if you have a modular cleanroom.

When your current cleanroom lacks integrity

If your cleanroom is unable to meet the standard for environmental control that your application requires, it’s time for a new one, or at least an evaluation and replacement of what’s not working in your current cleanroom. It could be that your filtration system is not operating efficiently and needs replacement or that your space is not properly sealed from the outside environment.

If you’re updating your current cleanroom, or starting from scratch, call the experts at Angstrom Technology.

When Should you Replace your Cleanroom Tech?

When Should you Replace your Cleanroom Tech?

Cleanroom equipment is expensive, but that’s because it’s high functioning, specialized equipment for an extremely important and sensitive job: maintaining your cleanroom’s integrity and required classification standards. But like all equipment, it breaks down, wears out, and slows down with time. So how do you know when to replace it?

Like your household appliances, your cleanroom equipment will have a general lifespan, after which you should replace it. Here are some general lifespan guidelines for common cleanroom equipment:

Equipment Expected Lifespan
Prefilters 2 months
HEPA filters 7 years
ULPA filters 7 years
HVAC system 10-12 years
Major analyzers/ automated equipment 7-10 years
Fridges/Freezers 5 – 12 years
Fumehoods 20 years
Autoclave 20 years
Centrifuges 7 -10 years
Microscopes 20 years
Microtomes 20 years
Waterbaths 7-10 years
Incubators 7-10 years
Balances 20 years
Warming Plates 10 years

 

You should always replace equipment as soon as something goes wrong with it that’s not repairable or when it becomes inefficient. If you have a piece of equipment that still technically “works” but isn’t performing at top efficiency, the money you think you’re saving by waiting to replace it is just going to be eaten up in energy costs.

No matter your cleanroom needs, Angstrom Technology can meet them with a modular cleanroom.

 

Best Practices for Working in a Cleanroom

Best Practices for Working in a Cleanroom

Whether you’ve been working in cleanroom environments for 20 years or it’s your first day on the job, a reminder of the basic best practices for working in a cleanroom can always be of use. Here are some things to keep in mind and implement when working in controlled environments:

  1. Follow written procedures

Written laboratory procedures exist for a reason: your safety, product safety, process integrity, cleanroom integrity, customer specifications, and legal compliance, to name a few of the major reasons. Going off script could cause major harm at worst, and at best, save you a few minutes time—hardly a worthwhile trade-off.

  1. Wear proper PPE

Again, this is about safety. Many cleanroom applications deal with hazardous or toxic chemicals and materials, and so wearing the required personal protective equipment, whether it’s gloves, goggles, or just safety glasses, is a must.

  1. Wear proper attire

If your cleanroom has a dress code or a specific gowning procedure, following it is crucial to minimizing contamination from outside as well as from your self, clothes, fibers, skin particles, etc.

  1. Don’t leave doors open

This one is obvious, but worth repeating: open doors let contamination in.

  1. Don’t leave hazardous materials out

Leaving hazardous materials unattended and out when not in use can lead to chemical spills and other accidents that are dangerous to personnel and compromise the cleanroom environment.

  1. Use a fume hood

When working with hazardous chemicals, using a fume hood is critical to keeping vapors and particles out of the air, protecting you and the cleanroom environment.

  1. Report issues immediately

From injuries and accidents to broken equipment, reporting any issues immediately is necessary for resolving them quickly and preventing bigger problems down the line.

Is it time to upgrade your cleanroom? Give Angstrom Technology a call.

Why You Need a Cleanroom, Not Just a Lab

Why You Need a Cleanroom, Not Just a Lab

When you’re in manufacturing, whether you’re dealing with pharmaceuticals, food, or even industrial products, quality is always a critical concern. When quality control matters, you have to test products, and most of that testing likely occurs in a lab. Some products will even need to be manufactured in a laboratory setting. But is your lab the right environment to ensure quality in your manufacturing processes? If it’s just a lab in name only, and not a true cleanroom, it might not be.

What’s the difference between a lab and a cleanroom?

A laboratory is a space dedicated to scientific research, experiments, and testing, as well as the manufacture of certain types of products. There is nothing in this definition that requires the laboratory environment to be controlled in any way. While a pharmaceutical manufacturer might have a highly controlled laboratory environment, a local high school might also have a lab, wherein students conduct experiments under no environmental controls.

A cleanroom is a controlled environment, specifically one that controls the level of contamination from particles, along with other factors such as temperature, humidity, static, etc. Controlling all of these variables protects your processes and products from contamination or conditions that could compromise the integrity of those products and processes.

Cleanrooms are required to meet specific standards as to the number of particles acceptable within the space, and to meet that standard, the cleanroom is regularly tested. Equipment and systems are put in place to maintain the cleanroom environment, including air filter systems and air flow systems, as well as procedures for entering and using the space, from special chambers called air showers that blow contaminants off of personnel before they enter the cleanroom to requiring lab coats or gowns for personnel working in the cleanroom.

Why do you need a cleanroom instead of just a lab?

If you’re not controlling your lab environment, there’s really no point in having one. It’s not going to ensure product quality, integrity, and safety—and those things are all necessary for a sound manufacturing process. For certain industries, like semiconductor manufacturing, pharmaceutical manufacturing, and aerospace and defense manufacturing (just to name a few of the many industries that use cleanrooms) cleanrooms are either required by law or are enforced as an industry standard. For example, automotive manufacturing cleanrooms are generally required to meet ISO Class 7 or 8 standards in order to meet the supplier requirements of the OEMs they work with and to ensure the quality of their products.

Is it time to upgrade your lab to a cleanroom? Get in touch with the cleanroom experts at Angstrom Technology.