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.

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.

 

What Not to Wear: Cleanroom Edition

What Not to Wear: Cleanroom Edition

Obviously, your cleanroom’s construction and air filtration system are critical factors in keeping your cleanroom contamination-free, but so is what people wear in the cleanroom. People and fabrics are major sources of contaminants, and it’s crucial your control those sources with proper attire. Here’s what (and what not) to wear in a cleanroom:

Do’s:

  • Hoods
  • Hair Covers
  • Coveralls
  • Intersuits
  • Boots or shoe covers
  • Facial Covers
  • Gloves
  • Frocks

Depending on the classification of your cleanroom, there may be different requirements for the garments you have to wear. For instance, an ISO 3 Class (Fed Std. Class 1) cleanroom will likely require all of the garments listed in the “do’s” above, and will likely require that those garments be changed for new or cleaned ones every time you enter the cleanroom, whereas an ISO Class 5 cleanroom will require most of those garments, to be changed every day, and an ISO Class 8 cleanroom will require only some of those garments and that they be changed every two weeks.

Don’ts:

  • Makeup
  • Long hair (uncovered or not pulled back)
  • Fibrous sweaters or materials that shed
  • Materials that cause static
  • Dirty clothes or shoes
  • Extremely loose or baggy clothing
  • Shorts, tank tops, or other clothing that has cutouts or exposes skin

The “don’ts” here are don’ts because these items can bring contamination into the cleanroom. Dirty clothes and shoes are the most obvious of these contaminators, but a lot of contamination can come from the skin and hair cells we lose every day without us even knowing. Makeup can also shed from the skin and cause contamination, as can the fibers from clothing.

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

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.

Choosing the Right Cleanroom Design and Installation Company

Choosing the Right Cleanroom Design and Installation Company

For facilities requiring a clean environment, the cleanroom itself is a crucial component. As a general contractor or builder, you know that finding the right company to design/build and service, your cleanroom is a critical part of your projects success. How do you choose the right cleanroom design company? Here are some qualities a good cleanroom design company should have:

Good communication—quick response times

Communication is essential in any construction project, and it’s vital for subcontracted work. The cleanroom design company that you chose should give respond quickly with a budgetary quote, and be able to answer any technical questions you may have in the design/build portion of your project. Once the project is underway supply you with weekly project updates, keeping your timeline in check.

Fast lead times and ability to meet deadlines

You don’t have months and months to get this cleanroom constructed—you need it done quickly and efficiently, within your timeframe. You have deadlines that you have to meet, and the cleanroom designer should understand and respect that. Given a reasonable amount of time and all the necessary information to complete the cleanroom project, a good cleanroom design firm should be able to make quick turnaround times and keep the cleanroom, and therefore the rest of your project, on schedule.

Customization capabilities

Good cleanroom designers will work with you to create the right cleanroom for the client, and this may include custom requests. Good designers aren’t inflexible—they won’t just provide a boilerplate, cookie-cutter, one-size-fits-all cleanroom, because the needs of each client are unique, based upon cleanroom application and other circumstances. The cleanroom design firm you choose should be willing and able to design custom elements such as casework, cleanroom benches, and tables, to fit the client’s specific needs.

Ability to stay on budget   

Cleanrooms can be an enormous cost for your client, and as such, the budget must be respected. If a cleanroom designer can’t stick to the agreed-upon budget, the project can’t succeed, and problems will arise for all parties, the cleanroom design company, you, and the client. Good cleanroom designers will be able to provide a workable cleanroom design within budget constraints.

Selecting the best company for your cleanroom design and installation project is the first and most essential step in providing your client with the cleanroom their company needs. Finding a cleanroom design company with good communication practices, quick turnaround times, the ability to customize, and budget-consciousness will ensure that your cleanroom design is a success.

If you’re tasked with a cleanroom design project and have questions about designing a new cleanroom, give the experts at Angstrom a call. We install all kinds cleanrooms and have a selection of necessary cleanroom equipment and supplies.

What is the Difference Between a Controlled Environment and a Cleanroom?

What is the Difference Between a Controlled Environment and a Cleanroom?

The words cleanroom and controlled environment are often used interchangeably when talking about environment control in critical spaces. But there is a difference, and that difference is crucial. When it comes to controlled environments vs. cleanrooms, here’s what you need to know:

 

What’s a controlled environment?

 

A controlled environment, or critical environment, is an area that must have certain parameters controlled, specifically, pressure, temperature, and segregation. Many laboratories are considered controlled environments, as they have controlled temperature and pressure and are separated from other operations, such as manufacturing or shipping. Unlike cleanrooms, controlled environments do not necessarily have to meet certain standards for particle contamination.

 

What’s a cleanroom?

 

A cleanroom is a type of controlled environment, but one with much more stringent requirements. Cleanrooms require temperature and pressure control, as well as separation from the outside environment and other operations, but these things must be controlled to specific standards. Cleanrooms are classified by the maximum acceptable numbers of particles (by size) in the air per cubic meter, and must be regularly tested to ensure compliance to that standard (see more about cleanroom classifications here). Compared with other controlled environments, cleanrooms may require more energy, air, and advanced technology to maintain the cleanroom conditions.

 

Which do I need, a cleanroom or a controlled environment?

 

This depends on two factors: your application and your industry. If you’re packaging medical devices, you’ll need an ISO class 7 complaint cleanroom, or higher. If you have a process control laboratory for a chrome plating company, you aren’t required to meet a specific ISO classification, but definitely need to control the environment. You may even have different needs within your facility; you may need a controlled storage environment for sensitive materials that may not need to meet cleanroom standards, but have and ISO class 8 cleanroom for quality control testing.

 

Angstrom has the experience and knowledge to design the right cleanroom for your application. Contact us today to find out more!