Where Are Critical Environment Cleanrooms Used?

Your Industry May Require Critical Environment HVAC Solutions

Critical environment cleanrooms are environments with strict air quality standards. The International Standards Organization (ISO) is the agreed-upon source for determining how cleanrooms are classified, based on air quality.

For example, a cleanroom can range between “ISO 1” and “ISO 9,” depending on the air particle sizes that are permissible in that environment. Additional standards, such as Federal Standard 209e, the EU, as well as industry-specific requirements, including those from the U.S. Food and Drug Administration (FDA), provide additional quantifiable measurements to classify cleanroom environments.

Designers create critical environment solutions—such as cleanrooms—in various layouts and configurations to ensure safe processes without the risk of contamination or infection, regardless of the specific classification. Keep reading to learn more about the industries that depend on these systems and how to find a leading critical environment manufacturing facility.

Industries That Rely On Cleanrooms

Organizations use cleanrooms in any environment where even the smallest airborne particle could affect sensitive equipment, laboratory research, organic processes, or production.

Although the following list is by no means exhaustive, this diverse set of industries use cleanrooms as a typical part of their day-to-day operations:

1. Pharmaceuticals: Pharmaceutical research laboratories and manufacturing plants both require stringent environmental conditions to ensure the safety and quality of their products. Pharmaceutical companies follow strict guidelines and regulatory procedures to protect against contamination in the environments in which they develop their products. Today’s most advanced biopharmaceutical technologies demand even more rigorous critical environment solutions, since these treatments rely on extremely sensitive materials.
2. Semiconductor plants: The engineering of microchips and other electronic components is a highly nuanced process. Therefore, even the smallest particles can negatively affect successful manufacturing processes. Semiconductor plants must adhere closely to cleanroom measurements at all times to ensure their products are not defective and operate as expected in our technology-forward marketplace.
3. Hospitals and healthcare facilities: Cleanrooms are used in certain parts of healthcare buildings where patients are most vulnerable to infection. Isolation rooms, operating rooms, treatment wards, and in-facility laboratories all must adhere to specific standards for air particle counts.
4. Medical device manufacturing: Because medical devices—especially those intended for use inside the human body—must be free of infectious particles, manufacturers build implanted devices and surgical equipment in cleanroom environments.
5. Manufacturing facilities for automotive products, aerospace, and defense products are also exceptionally strict when it comes to indoor air quality. In each of these industries, safety and precision are of the utmost importance, whether the facility is manufacturing airbags or devices that detect objects in airspace during defense scenarios. Incredibly, air quality can mean the difference between a reliable system and one that fails while in operation.

Kinds of Critical Environment Solutions

Cleanrooms are as varied as the industries that require them. Builders can integrate some cleanrooms into existing construction frameworks when the processes involved don’t require meeting the highest ISO benchmarks.

For example, an operating room cleanroom can exist within an operating room’s original walls and requires the installation of a critical environment HVAC solution, such as a ceiling system and other components. Teams install these systems to create the environmental conditions essential for preventing infections—an approach known as a hybrid cleanroom.

However, other cleanroom environments require complete modular design, including the walls, so that the entire area is completely sterile and is, in a sense, cut off from the rest of the facility. Manufacturers often use these cleanroom types to produce specific parts for medical devices, microchips, and in environments where pharmaceutical compounding occurs.

Finding a Critical Environment Manufacturing Facility

Finding a manufacturer that creates cleanroom components for your industry requires research and careful vetting. When you visit a prospective cleanroom manufacturer, consider the following:

• Does this manufacturer build for my industry?
• Do they share regular insights on my industry, including standards and requirements?
• Do they build critical environment systems and products?
• Do they share examples of cleanrooms they’ve built that match my facility’s processes?

If this is the case, a second level of questioning may be required to ensure you’re getting additional value from this manufacturer:

• Does this critical environment manufacturing facility offer turnkey solutions, so that the management and coordination of my installation, along with engineering support, is completely taken care of?
• Does this team use modular critical environment HVAC solutions to reduce cost, ensure single-source responsibility, and protect my facility from unnecessary project roadblocks?

Explore the work of one critical environment manufacturer that designs superior products for many sectors, including medical, pharmaceutical, industrial, and more.