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.

Understanding Cleanroom ISO Classes

Understanding Cleanroom ISO Classes

Cleanroom classification can be confusing, especially when there are multiple standards used in multiple industries and there is overlap in those standards. Here we’ll focus specifically on ISO classes: what they are and why they matter.

What are the ISO classes?

The ISO classification system has eight classes, ISO Class 8 being the least controlled and ISO Class 1 being the most controlled.

Maximum Number of Particles in Air by Particle Size

ISO Class ≥ 0.1μm ≥ 0.2μm ≥ 0.3μm ≥ 0.5μm ≥ 1μm ≥ 5μm
ISO 1 10 2 0 0 0 0
ISO 2 100 24 10 4 0 0
ISO 3 1000 237 102 35 8 0
ISO 4 10000 2370 1020 352 83 0
ISO 5 100000 23700 10200 3520 832 29
ISO 6 1000000 237000 102000 35200 8320 293
ISO 7 352000 83200 2930
ISO 8 3520000 832000 29300

 

Why does ISO classification matter?

Most laboratory and cleanroom applications require a controlled environment. The level of control depends on both the industry and the specific application. Cleanroom classes serve as a standard that can be easily referenced for the required level of environmental control. Additionally, they serve as a standard for certification to ensure that a cleanroom meets the proper level of control for the industry and the specific tasks performed in that cleanroom.

To create a cleanroom that meets your required ISO standard, contact Angstrom Technology. For more on cleanroom classifications and standards, including Federal Standard 209E, check out our guide.

Designing Your Food Microbiology Cleanroom

Designing Your Food Microbiology Cleanroom

Food microbiology labs have a variety of special considerations due to the sensitive nature of the work and its importance. Not only do they need dedicated laboratory space for testing, but the controlled environment of a cleanroom is also critical. Here are some things to consider when designing a cleanroom for food microbiology applications.

Location

Food microbiology cleanrooms should be located conveniently to the production area from which samples are being tested; however, it should be away from main transportation arteries, noisy areas, boilers, and other heavy equipment.

Setup

Depending on your company’s production needs or your specific lab’s application, your food microbiology cleanroom will likely include a chemical laboratory, bacteria laboratory, and office spaces. These areas will likely require multiple rooms. The bacteria lab will probably require a sterile room, examination and operation rooms, and media production studios. Biological testing should always and necessarily be separated from other cleanroom operations. The chemical lab may require a chemical analysis room as well as an instrument room. The offices will need to be accessible to lab personnel as well as other employees, and will likely require a different level of access and control than the rest of the cleanroom space, meaning separation from other cleanroom areas.

ISO Classification

Generally speaking, food manufacturing and food microbiology cleanrooms must meet ISO Class 5 or 6 (Fed-Std 209E Class 100 or 1,000). This means that recommended air changes per hour are between 150 and 600, with 25 to 70 percent ceiling coverage. (For more information on the maximum number of particles in air allowed per cubic meter of each particle size, check out our guide to cleanroom classifications & standards.)

Maintaining a controlled environment is critical for a food microbiology cleanroom. If you want a cleanroom that’s designed and built right, call 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.