Cleanroom Classification Standards for Beginners
- zachsievert15
- Jul 1
- 5 min read
If you’re stepping into the world of cleanrooms for the first time, the number of standards, classifications, and technical terms can feel overwhelming. Whether you're planning a new facility or working to meet regulatory expectations, understanding cleanroom classification standards is a key part of designing and maintaining a controlled environment. This guide will break it all down in a clear and straightforward way.
Table of Contents
What Is a Cleanroom?
A cleanroom is a specially constructed space designed to control airborne particles, temperature, humidity, and other environmental conditions. These spaces are used in industries where even microscopic contamination could affect outcomes—like pharmaceutical manufacturing, electronics, biotechnology, aerospace, and more.
Cleanrooms are built to strict cleanroom standards to protect both the product and the people working inside. They're part of a larger ecosystem of cleanroom construction, cleanroom HVAC, air filtration systems, and wastewater management systems that ensure everything operates smoothly. The integrity of a cleanroom depends on several factors working together—filtration, airflow, materials, and pressure control—all tailored to meet specific classification levels.
Why Cleanroom Classification Standards Matter
Cleanroom classification standards set the rules for how clean a cleanroom needs to be based on its intended use. These standards help ensure consistency, safety, and regulatory compliance across different industries and regions.
They are especially important when a cleanroom is being certified for the first time or recertified during routine inspections. Cleanroom certification requires meeting specific thresholds of cleanliness, which are defined by these standards. Having a clear understanding of them makes the entire cleanroom design and management process smoother and more efficient. These classifications also serve as a common language across industries, helping teams coordinate better from design through operation.
Understanding ISO Classifications
The most commonly used standard for cleanrooms is ISO 14644-1, which defines cleanroom classifications based on the number of airborne particles per cubic meter of air. ISO classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the least stringent).
For example:
ISO Class 5 is commonly used in pharmaceutical filling operations and semiconductor production.
ISO Class 7 or 8 might be sufficient for less sensitive processes like storage rooms or pre-packaging areas.
Here’s a quick breakdown:
ISO Class 1: Fewer than 10 particles per cubic meter
ISO Class 5: Approximately 3,520 particles per cubic meter
ISO Class 8: Up to 3,520,000 particles per cubic meter
The class you need depends on your application. Electronics manufacturing might require a Class 5, while certain medical device assembly areas may be fine with a Class 7 or 8. Understanding these requirements upfront helps avoid costly redesigns or operational disruptions later.
How Air Filtration Systems Impact Cleanroom Classes
Your air filtration system is one of the most critical parts of meeting cleanroom classification standards. High-Efficiency Particulate Air (HEPA) and Ultra-Low Penetration Air (ULPA) filters remove contaminants from the air, maintaining cleanliness levels appropriate to your clean room classification.
These filters are typically installed in the ceiling and recirculate air through return vents. Depending on the class of your cleanroom, the air may be changed dozens or even hundreds of times per hour (called air changes per hour, or ACH). The higher the classification requirement, the more frequently the air needs to be filtered and replaced. Filtration design isn’t one-size-fits-all—everything from ceiling layout to pressure zones must be customized to match the space's classification and use case.
Cleanroom Certification and Compliance
Cleanroom certification is the process of testing your facility to make sure it meets required cleanroom classification standards. Certification can be done by third-party firms or specialized cleanroom contractors. During this process, particle counts, airflow velocity, air pressure, and filtration efficiency are measured and documented.
If your business is regulated by the FDA, EPA, or other governing bodies, certification and continued compliance aren’t optional. It's an essential step in maintaining quality assurance and avoiding costly shutdowns or product recalls. Routine monitoring and re-certification also keep your cleanroom within spec, especially as processes or personnel change over time.
Common Applications by Classification Level
Each cleanroom classification serves a different industry need. Here are a few examples:
ISO Class 5: Sterile drug compounding, semiconductor manufacturing
ISO Class 6–7: Medical device assembly, pharmaceutical production
ISO Class 8: Food packaging, general electronics assembly
Knowing which cleanroom standard matches your operations can save time and money during the design and construction process. It also helps with future scalability if you plan to expand or update your facility.
How Cleanroom HVAC Design Supports Standards
Cleanroom HVAC systems do more than just control temperature—they manage pressure differentials, humidity levels, and air exchange rates. These elements are essential to maintaining a controlled environment and achieving consistent cleanroom classification results.
For instance, pressurization strategies are used to prevent contaminated air from entering sensitive clean rooms. Humidity control also helps reduce static electricity in electronic cleanrooms or maintain necessary moisture levels in pharmaceutical environments. HVAC systems are tailored specifically to cleanroom standards and should be designed by professionals with experience in cleanroom engineering. A well-designed HVAC system also supports energy efficiency, which is a growing concern for facilities managing long-term operating costs.
Working with a Cleanroom Contractor
Working with an experienced cleanroom contractor can help translate your operational requirements into a functional cleanroom design. These professionals bring together construction management, cleanroom certification, cleanroom HVAC, and more—ensuring your facility meets industry standards while staying on budget and on time.
Cleanroom contractors can also help you identify potential roadblocks early in the planning phase, from regulatory requirements to space constraints and mechanical integration. That kind of foresight keeps your project on track.
Cleanroom Classification Standards and DesignTek Consulting
At DesignTek Consulting, cleanroom classification standards are at the core of every design and construction project we take on. From concept to commissioning, our team ensures that your cleanroom meets the specific iso standards required for your industry—whether you're building from scratch or upgrading an existing space. We offer a wide range of services to assist in your cleanroom build.
We combine technical precision with real-world experience in cleanroom HVAC, cleanroom construction, air filtration systems, and wastewater management to ensure your space performs as expected. We understand how to design cleanrooms that are compliant, efficient, and built to last. Looking to build or upgrade a cleanroom that meets strict classification standards? Contact us at DesignTek Consulting. We’ll help bring your vision to life with precision, compliance, and clarity from day one.