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A Look at Cleanroom Clothing Requirements

By Henry Skjerven
Last updated: March 1, 2022
Key Takeaways

Cleanroom clothing doesn't have to be complicated, but making the wrong selection could contaminate your equipment or products.

Protective clothing is an essential piece of safety equipment meant to protect the wearer from various exposures. One subset of protective clothing, however, serves a second purpose. While cleanroom protective clothing guards the wearer against exposure to various hazards, it is also designed to prevent the cleanroom from becoming sullied by contaminants from the wearer's clothing or person (learn about 4 Key Types of Protective Clothing to Know and Understand).

Protective clothing, then, is essential for keeping a cleanroom, well, clean. It helps contain the skin and hair we are constantly shedding, as well as bacteria, mucus, germs, and other things that may be inadvertently introduced in the cleanroom atmosphere.

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What Is a Cleanroom?

A cleanroom is a space used for manufacturing or research that must be kept free of dust and other particles.

It is also typically temperature- and humidity-controlled to protect the sensitive equipment or manufactured components within it.

To access a cleanroom, workers need to walk through an air blast (or air shower) that will blow away the particles on their clothing. Items may be introduced to into the cleanroom by being passed through an airlock.

Cleanrooms are used in a number of applications, including:

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  • Pharmaceuticals
  • Aerospace
  • Food processing
  • Medical device manufacturing
  • Manufacturing electronic components
  • Laboratories and research facilities

Cleanroom Protective Clothing Standards

OSHA

While OSHA does have guidelines for industrial cleaning that includes information on cleaning cleanrooms, it does not have a standard for cleanroom protective clothing.

ISO

The current international standard for cleanrooms is ISO 14664. It outlines 10 classes of cleanroom, along with the type of protective clothing required for each.

To give you a sense of what cleanroom clothing involves, here is what the ISO standard requires for the "most clean" (Class 1) protective clothing:

  • Hood
  • Bouffant hat
  • Coverall
  • Intersuit (worn undreneath the coveralls)
  • Boot covers
  • Goggles
  • Facemask
  • Gloves

The standard also recommends changing all of this protective clothing with every single entry to the cleanroom. Wearing the protective clothing outside the sterilized environment can cause particles to adhere to it, which compromises the cleanliness of the clothing.

Disposable Vs. Reusable Protective Clothing

Once you have conducted an analysis and determined the level of protective clothing required in your cleanroom, you will face a key decision: do you purchase reusable or disposable protective clothing?

Important considerations include:

  • Cost
  • Wearability
  • Worker comfort
  • Disposal procedure (and associated costs)
  • Laundering or sterilization requirements

Disposable Protective Clothing

While using protective clothing that can simply be discarded after each use is often the easiest solution, it's important to take the disposal process into consideration.

Depending on the work being done, disposable cleanroom clothing might have to go into a different waste stream than ordinary waste. If that is the case, it may affect the cost and convenience of using this type of equipment.

When dealing with the strictest classes of cleanrooms (especially Class 1 cleanrooms), disposable, single-use clothing is usually the most effective (and cost-effective) option (learn about 6 Jobs That Call for Disposable Clothing).

Reusable Protective Clothing

Non-disposable clothing also presents certain issues and inconveniences. If the laundering and cleaning of the equipment is handled by an offsite facility, you have to make ensure that there the cleaning and transporting of the equipment to the site does not introduce any contaminants.

In one case, an audit of a food processing facility uncovered that the protective clothing the company used in its cleanroom was transported to their facility from a local laundry facility by a driver who also picked up soiled laundry from three motels on his way. Further review revealed that the protective clothing was sometimes washed and dried together with the motel's towels and sheets. The water and dryer temperature settings, moreover, did not meet the relevant standards or match the documented needs of the processing plant.

As this illustrates, ensuring that the clothing is properly laundered and handled should be factored in as one of the additional costs. It's one corner that should definitely not be cut.

Combining Both Options

In some cases, it might be best to use a combination of both disposable and reusable protective clothing.

Faceshields, for instance, might be sanitized after use even if most of the protective clothing employed is disposable.

Tips for Purchasing Cleanroom Clothing

  • Make sure that the clothing you purchase matches the recommendations from your cleanroom risk and hazard analysis.
  • Cheaper options are not always better, even when it comes to disposable clothing. Some more expensive options are also sturdier and can prevent accidental rips and tears in the material.
  • Some disposable protective clothing can be used more than once. The manufacturer will inform you whether this is the case.
  • Buy sizes that meet or match your workers' measurements. Keep enough large and extra-large protective clothing on hand to meet emergency or unforeseen circumstances.
  • The protective clothing should be individually sealed and packaged, or stored in a cleanroom until use. When it comes to cleanroom clothing, how you store it is just as important as how you use it.

Summary

Managing your cleanroom is not necessarily complex, but it is detailed and requires performance management and a proper audit.

Selecting protective clothing also doesn't have to be complicated. But when it comes to cleanrooms, you must make sure that it performs both of its functions adequately: protecting the worker and containing contaminants.

Check out the rest of our Personal Protective Equipment content here.

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Written by Henry Skjerven

Henry Skjerven

Mr. Skjerven has consulted professionally for over 27 years, with extensive Canadian experience, literally from coast to coast but with a home base in Western Canada. His experience ranges from marketing, adult education, and heavy transportation (rail) to municipal public works, fleet and transportation, oil and gas construction in the tar sands, emergency response (Fire and Ambulance), Public Works, Parks and Recreation, Security, as well as human resources and software systems, including enterprise style projects.

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