Beyond Sterile: What is a Cleanroom or Clean Room, and Why is it Important?

There are levels to 'clean' spaces – and cleanrooms are right at the top.

That spring cleaning you did at home after the holidays doesn't cut it. Neither does the deep scrub of hospital surfaces in midst of the pandemic. Cleanrooms are essential for industries working with highly sensitive materials that can be contaminated by airborne particles – and the standards that are met here are leagues beyond the routing cleaning people used to.

Think of a semiconductor chip being made. One particle in the wrong place, and it's ruined. These are the chips that go into your smartphones, cars, drones, laptops – basically that requires some form of computing power to function. Chips getting contaminated during production disrupts their complex circuits, leading to loads of money being wasted.

In fact, you can argue that humans are chief contaminators in cleanrooms. So much so that when inside, workers must wear full cleanroom suits depending on the ISO classification. These are not for their protection - but rather to protect the silicon wafers, just one type of industries, (what semiconductor chips are manufactured from) from pollutants like hair, dust, and other tiny particles that people naturally carry. And there's more: advanced air conditioning systems work around the clock to purify the air, capturing any elusive particles that might have managed to escape from the workers' suits. Vacuum-sealed robots are also used to do most of the operations to minimize the risks.

Why all these stringent measures? Well, let’s start at the beginning.

What Is A Cleanroom or Clean Room? The Definition

Simply put, a cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out to specified levels. The particles are continually to ensure compliance with strict standards.

Cleanrooms are categorized based on the number and size of particles allowed per volume of air. A ‘class 100’ cleanroom, for instance, under FED-STD-209E, means only 100 particles of size 0.5 mm or larger are permitted per cubic foot of air.

The Shift To ISO

Now, standards have evolved over time. The U.S. based Federal Standard 209E was cancelled, giving way to the internationally recognized ISO Standards, indicating a transition to more universally applicable standards. Going by ISO 14644-1, cleanrooms are classified based on the number and size of particles permitted per volume of air. To put it simply, the lower the number, the fewer particles allowed, making it “cleaner.” For example, an ISO 5 cleanroom allows a maximum of 100,000 particles at 0.1 µm per cubic meter.

Here’s a quick difference – FS209E has six classes, and ISO 14644-1 has nine. In FS209E, the cleanest cleanroom is Class 1 and the dirtiest is class 100,000. ISO classifications are similar but extend from class 1, the cleanest, to class 9, the dirtiest. ISO class 3 is about the same as FS209E class 1, and ISO class 8 is about the same as FS209E class 100,000.

Moreover, different regions have their own standards. For instance, the GMP EU Cleanroom Classifications Grades A, B, C, D represent specific requirements in Europe, aiming to minimize risks of contamination during the manufacturing of sterile products. Grade A is approximately equal to ISO 5, while Grade D can be equated to ISO 8. Compare ISO and GMP EU Cleanroom Classifications here.

These standards are routinely evaluated and refined to address emerging requirements and to ensure maximum control over contaminants.

Importance of Controlling Contaminants

Dealing with contaminants isn't just about keeping a space squeaky clean. It's about ensuring the purity and quality of what's being produced inside. Any unwanted particle or microbe can wreak havoc, potentially ruining products and setting back weeks or even months of work.

• Protection of Sensitive Processes: Some procedures are extremely delicate. Even a minute contaminant from dust, airborne microbes, aerosol particles, and chemical vapors can spoil an entire batch of product – be it microchips for smartphones and EVs, high-precision lenses for telescopes, or nuclear fuel rods in the energy sector.

• Safety First: In fields like pharmaceuticals and biotech, contamination could lead to products that are unsafe for consumption. The manufacturing of medical devices such as implants and surgical instruments also requires strict cleanliness – you don’t want pathogens getting to heart valves during production, and then transferring to patients in the OR.

• Cost Efficiency: Reducing waste and rework by preventing contamination saves money in the long run. That way you won't wind up with defective electronics that will need to be replaced right at the production stage, especially critical in sectors like aerospace where any flaw can have grave consequences.

• Regulatory Compliance: Many industries are required to adhere to strict cleanliness standards. Falling short can mean hefty fines or business closure. For instance, pharmaceutical manufacturers are required by the FDA to maintain strict controls in their cleanrooms, accurately monitoring everything from the airborne particles and air pressure, to the airflow, humidity, temperature, and even lighting. Each cleanroom must be equipped with a monitoring system.
  

Applications of Cleanrooms in Different Industries

Pharmaceutical and Biotechnology Industries

Here cleanrooms are needed safeguard the sanctity of products like sterile meds. Without them, contamination risks would go through the roof, compromising product safety and patient health. For instance, with vaccines, cleanrooms ensure that they are manufactured, stored, and packaged without contamination, maintaining their effectiveness and safety, thus protecting millions from infectious diseases.

These industries have strict regulations. The FDA, along with other regulatory bodies, has outlined guidelines to ensure the production processes are free from contaminants that can alter the composition and efficacy of the products – like the Guidance for Drugs produced by Aseptic Processing, in line with Current Good Manufacturing Practice (CGMP).

Semiconductor and Electronics Industries

In the world of semiconductors and electronics, cleanrooms are critical! We’re talking about places that are about 10,000 times cleaner than the air we breathe outside. The air here is constantly filtered and refreshed, and the people working there wear special outfits (you might hear them called ‘bunny suits’) to ensure no particles from their clothes or bodies contaminate the air, depending on the cleanroom ISO rating.

Most of these companies have ‘ISO 3 or Class 1’ cleanrooms, that are practically ‘dust-free’. In these rooms, there are no more than 10 tiny particles at 0.3 µm, per cubic meter of air. To give you a comparison, even a neat and tidy modern hospital has about 10,000 dust particles per cubic meter of air.

How clean is clean? The cleanroom at Goddard Space Center in Maryland, where NASA put together the James Webb Space Telescope, is considered an ISO 7 environment. This means it can have 352,000 tiny, half-micron-size particles in every cubic meter of air. But the ASML cleanrooms in the Netherlands follows the stricter ISO 1 standard. ASML makes photolithography machines, used for the mass production computer chips.

Aerospace and Automotive Industries

When building intricate devices that will explore distant planets and moons in the aerospace sector, you want precision and perfection. Cleanrooms in this field are used to assemble and test things like spacecrafts, satellites, or intricate instruments under strictly controlled conditions to avoid even the smallest contaminants that could compromise the integrity of space missions. The last thing you want is a speck of dust in the production stage ruining an entire space expedition later on.

For the automotive industry, cleanrooms aren’t any less important. This is especially during the assembly of highly specialized automotive parts like sensors, airbags, or electronic control units. This ranges from everyday family sedans to high-performance racing cars destined for Formula 1 circuits or the NASCAR track. Here, any contamination can result in the failure of these components, which can be disastrous, putting vehicle performance and passenger safety at risk.

Healthcare and Medical Research

Cleanrooms provide the controlled environment needed during medical procedures, research, and the production of medical devices.

Take creating critical medical devices like heart valves or artificial joints for instance. Manufacturing a prosthetic limb in a cleanroom ensures that no foreign particles compromise its integrity or functionality. That way, patients can safely use the prosthetic.

Some surgical procedures, especially those involving implants or transplantations, require sterile environments to minimize the risk of infections. These specially controlled spaces mean that surgeons can operate with precision without worrying about airborne contaminants affecting the surgical site or the implanted materials.

In fields like stem cell and genetic research precision and contamination control are crucial. Whether researchers are working on gene-editing techniques or cultivating stem cells, the controlled environment of a cleanroom is essential for preventing any external interference that could compromise the research outcomes.

Factors To Consider When Designing and Constructing A Cleanroom

1. Project Budget

First things first, set your budget. Nobody likes unexpected expenses! Costs can vary based on cleanroom size, type (like HardWall, SoftWall, or Modular), classification (i.e. ISO, GMP EU classifications depending on the jurisdiction) and all those bells and whistles you might want. If you're going for a top-tier classification with additional features, like process piping and gowning rooms, be prepared to shell out a bit more.

2. Modular vs Traditional Cleanroom

Modular cleanrooms are constructed with prefabricated components. These are popular for their flexibility and versatility. The ease of installation, minimal maintenance, and adaptability to the changing needs of your facility operations makes them a valuable investment in the long run.

Traditional cleanrooms can't be easily relocated and require extensive renovation when moving. You may need to completely tear down existing walls and systems when renovating. While traditional construction can take months, modular construction, with pre-manufactured components, can be completed in shorter time (depending on the supply chain delays we are currently experiencing). Modular cleanrooms could also have a tax advantage (consult your financial advisor or CPA) and assembled by in-house staff, and manufacturers often provide installation guidance or services.

3. Find Your ISO Sweet Spot

The ISO classification you need will be based on the maximum number of particles you can have floating around. For specific applications like pharmaceutical production, more stringent classifications are required, whereas, for basic manufacturing, like automotive parts, lower classifications may suffice.

4. Optimize for Process Flow

Before you lay the first brick, you should know how everything will move in your cleanroom. From the entrance to the exit, and every operation in between, it's essential to have a bird's eye view. Understanding the flow can help you decide the perfect spots for your work surfaces, equipment, and even the filters. Plus, it ensures everyone has enough room to move around without bumping into each other.

Purity and Precision: The DesignTek Way

Cleanrooms are crucial catalysts for innovation and are pivotal in ensuring product reliability across various industries. From creating the latest tech gadgets to forging breakthroughs in medicine, these controlled environments are at the heart of it all. They directly contribute to advancements that shape our future.

At DesignTek Consulting, we get it. We understand the meticulous details and care that goes into creating and maintaining these essential spaces. Our commitment to excellence ensures that you get a cleanroom that not only meets the stringent standards but also aligns with your specific needs. With our wealth of experience in cleanroom design and construction, you can rest assured you're in good hands.

Thinking about setting up a cleanroom or need some expert advice? Reach out to us! We're here to help and guide you every step of the way. Give us a ring at (855) 203-2958 or drop an email at info@dtcdesign.us. Let's bring your vision to life!