4 min read

Why is ISO Cleanroom Certification so Important?

By Scott Chambers on Dec 7, 2020 12:39:00 PM

Topics: Medical
Cleanroom Converting

Some complex products require specific manufacturing processes to ensure their safety and reliable performance. What kind of performance? Well, in medical applications, particles in the air as well as the air’s moisture level can lead to bacteria growth that alters adhesion in a medical product applied directly to the skin.

Obviously, “bacteria” and “medical product” never go hand-in-hand. Combatting this possibility (and many others within numerous industries) requires the use of a cleanroom. Impurities of many types — dust/smoke, equipment, microorganisms, inadequate air quality, human error, and others — can cause defects in many products.

How “clean” does a cleanroom need to be? Classifications have been established using the ISO classification system ISO 14644-1 and are rated by the cleanliness level of the air inside the room. The most common ISO classes (ISO 7 and ISO 8) indicate the level of cleanliness of the room based on the quantity and size of particles per volume of air.

In this article, we’ll explore the ins and outs of ISO cleanroom certification, the industries most affected by cleanrooms, and the importance of your converting partner being certified.

What is ISO Cleanroom Certification?

Cleanroom classification ranges from ISO 1 (the “cleanest”) to ISO 9 (the “dirtiest”). Assigning these classifications is based on the maximum allowable concentration of particles per volume (cubic foot or meter) of air.

For instance, in order for a cleanroom to achieve ISO 7 certification, also known as Class 10,000, there must not be greater than 325,000 air particles (each .5 microns in size) per cubic meter. In comparison, an ordinary room contains at least 35,200,000 particles per cubic meter, making an ISO 7 cleanroom more than 100 times cleaner.

Why use ISO 7 as an example? Because these industries regularly use ISO 7 cleanrooms:

  • Medical device manufacturers
  • Electronic device manufacturers
  • Aerospace product development
  • Pharmaceutical compounding
  • Plus laboratories in many industries

How Do You Control a Room to Achieve ISO Cleanroom Certification?

Cleanrooms must control certain environmental variables in order for processes within to produce complex products reliably. Air quality is extremely important in cleanrooms and is the basis for ISO certification levels. Dust, dirt, and particles in the air can promote the growth of bacteria and mold over time, especially if accelerated by heat and humid environments during transportation or long-term storage of finished products.

Cleanrooms may use an industrial dehumidifier to control humidity levels. A separator filter dryer (SFD) separates dirt and air particles, filters air, and removes moisture. In addition to environmental control equipment, workers may need to wear facemasks, hair and beard covers, lab coats, coveralls, or sterile gloves. Clothing must be made from nonwoven fabrics to prevent shedding material fibers from contaminating the room.

Even entering/exiting the cleanroom may have their own safety processes. Sticky mats remove contaminants from shoes. An area called a “pass-thru cabinet,” usually equipped with a filtration system, is used to transfer products and also limit how many people can enter and exit the room.

In addition to those mentioned above, here are other common ISO 7 cleanroom requirements:

  • HEPA fan filters
  • Air locks and air conditioners
  • Heat welded floors
  • Sealed lighting
  • Stainless steel bench
  • Hands-free sink
  • Gowning atrium

Not surprisingly, cleanroom requirements vary based on the industry and the processes performed within the room.

ISO 7 Cleanroom By the Numbers

  • Air cleanliness — maximum of 325,000 air particles (≥0.5µm) per cubic meter (m³); also called “Class 10,000” because the maximum equals 10,000 particles per cubic foot
  • Air filtration — systems must provide filter coverage of 15-25% with at least 60 air changes per hour
  • Air flow rate — filtration system must be 9-16 CFM per square foot
    ISO 14644-1 — in 2001, replaced federal standard 209E (still used as a reference)

Why Should Your Converting Partner be ISO Cleanroom Certified?

Some products simply can’t be manufactured properly and reliably outside the environment of a certified cleanroom. When you partner with a converter that’s ISO cleanroom certified, you know they’re confident with taking on projects in the most demanding industries — medical devices and wound care, for instance — that require extreme precision while following strict manufacturing guidelines for converted goods.

These converters typically have a full team of design and development engineers on staff that allows them to invest the necessary time and resources for each project. A converter with cleanroom may offer these services to meet strict regulations:

  • Custom rotary, flat bed, and laser die cutting of specialty materials
  • Laminating, slitting, and rewinding … all in a climate-controlled environment
  • Continuous roll-to-roll manufacturing
  • Assembly
  • Packaging

Cleanrooms must follow best practices to ensure consistent performance that meets requirements. These may include gowning procedures, housekeeping processes/schedules, training, auditing, and making improvements when needed. Just as new technology advances materials and products, contamination threats also increase, so cleanroom best practices need to evolve as well.

What Does Certification Have to do With Microfluidics?

Microfluidic devices, including lab-on-chip technology, perform chemical analyses of very small volumes of fluids at the point-of-care. To achieve consistent, accurate, and reliable performance, the advanced materials within microfluidic devices must be kept clean. Following ISO cleanroom standards ensures that a converter adheres to strict manufacturing guidelines and likely has expertise in medical and healthcare manufacturing.

In 2014, Strouse’s cleanroom was certified to ISO 7 standards by Atlantic Technical Systems, yet the cleanroom was operating at this level for several years before. So for nearly a decade, Strouse has been taking on demanding medical and electronics projects that require extreme precision and accurately following all guidelines.

If you don’t know flexible material converting in and out, read our guide loaded with answers and insights: Flexible Material Converting Q&A. Have a question on ISO cleanroom certification? Give Strouse a call today (800)-410-8273 or you can ask an engineer!

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Scott Chambers

Written by Scott Chambers

As the VP of Marketing for Strouse, Scott oversees the content creation team and drives demand to the sales team. Scott graduated from Coastal Carolina with a degree in Business Management. He then attended the University of Baltimore School of Law, earned his JD, and passed the bar in 2016. In addition to marketing and business development, Scott serves as Strouse's In House Counsel. Scott is currently earning an MBA from Indiana University.

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