Understanding Cleanroom ISO Classes

Understanding Cleanroom ISO Classes

Cleanroom classification can be confusing, especially when there are multiple standards used in multiple industries and even multiple types of cleanrooms, and when 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 11020000
ISO 21002410400
ISO 310002371023580
ISO 41000023701020352830
ISO 51000002370010200352083229
ISO 61000000237000102000352008320293
ISO 7352000832002930
ISO 8352000083200029300

 

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 are a specific type of cleanroom that 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:

EquipmentExpected Lifespan
Prefilters2 months
HEPA filters7 years
ULPA filters7 years
HVAC system10-12 years
Major analyzers/ automated equipment7-10 years
Fridges/Freezers5 – 12 years
Fumehoods20 years
Autoclave20 years
Centrifuges7 -10 years
Microscopes20 years
Microtomes20 years
Waterbaths7-10 years
Incubators7-10 years
Balances20 years
Warming Plates10 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.

 

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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.

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