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Views: 0 Author: Site Editor Publish Time: 2025-08-21 Origin: Site
Are you unsure which cleanroom classification your industry needs? Choosing the correct classification can make or break your product quality and compliance. Cleanrooms range from ISO 1 (the strictest) to ISO 9, each designed to meet different industry requirements.
In this post, we’ll explore cleanroom classifications, their importance, and how to select the right one for your business. You'll learn the differences between classifications and how to align them with your specific industry needs.
Cleanrooms are categorized based on the number of particles in the air, measured in microns. The cleaner the room, the fewer particles are allowed per cubic meter. Cleanrooms are classified from ISO 1 to ISO 9, with ISO 1 being the cleanest and ISO 9 the least clean.
Each classification indicates the maximum number of particles of specific sizes that can be present in the air. For instance, an ISO 1 cleanroom allows just 10 particles per cubic meter at 0.1 microns. As the classification number increases, the allowable particle count also increases.
Here’s a quick look at the maximum particles allowed for each classification:
| ISO Class | Particles per m³ at 0.1 µm | Particles per m³ at 0.5 µm |
|---|---|---|
| ISO 1 | 10 | — |
| ISO 2 | 100 | 4 |
| ISO 3 | 1,000 | 35 |
| ISO 4 | 10,000 | 352 |
| ISO 5 | 100,000 | 3,520 |
| ISO 6 | 1,000,000 | 35,200 |
| ISO 7 | 10,000,000 | 352,000 |
| ISO 8 | 100,000,000 | 3,520,000 |
| ISO 9 | 1,000,000,000 | 35,200,000 |
ISO 14644-1 is the international standard that defines the classification of air cleanliness in cleanrooms. It measures the concentration of airborne particles and provides guidelines for cleanroom design and maintenance.
This standard specifies the limits for particles of various sizes in the air, such as 0.1, 0.2, and 0.5 microns, depending on the cleanroom classification. It is essential for industries like pharmaceuticals, semiconductor manufacturing, and biotechnology, where contamination control is critical for product safety and quality.
Cleanroom classifications are based on the number of airborne particles allowed per cubic meter of air. The stricter the classification, the fewer particles are permitted, ensuring a cleaner environment. Below, we break down the ISO classifications from the cleanest (ISO 1) to the least clean (ISO 9).
ISO Class 1: The cleanest environment, ideal for semiconductor manufacturing, nanotechnology, and high-precision research. These cleanrooms maintain an ultra-sterile environment with minimal contamination.
ISO Class 2-3: Highly controlled environments used for pharmaceutical manufacturing, advanced biotechnology, and other critical processes. These cleanrooms are essential for ensuring product safety and quality in sensitive industries.
ISO Class 4-5: Suitable for general pharmaceutical production, electronics, and some medical device manufacturing. These rooms allow for a slightly higher particle count but still maintain a controlled environment.
ISO Class 6-9: Less stringent, but still necessary for certain industries like food processing, agriculture, and general assembly. These cleanrooms offer basic contamination control without requiring the high precision of stricter classifications.
Here’s a breakdown of the maximum number of particles allowed per cubic meter at different particle sizes for each ISO class:
| ISO Class | ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥1.0 µm | ≥5.0 µm |
|---|---|---|---|---|---|---|
| ISO 1 | 10 | 2 | — | — | — | — |
| ISO 2 | 100 | 24 | 10 | 4 | — | — |
| ISO 3 | 1,000 | 237 | 102 | 35 | 8 | — |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | — |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 |
| ISO 7 | — | — | — | 352,000 | 83,200 | 2,930 |
| ISO 8 | — | — | — | 3,520,000 | 832,000 | 29,300 |
| ISO 9 | — | — | — | 35,200,000 | 8,320,000 | 293,000 |
For example, an ISO Class 5 cleanroom allows up to 100,000 particles per cubic meter at 0.1 microns. This level is often used in pharmaceutical compounding to ensure the safety and sterility of the products being manufactured.
Cleanroom classifications are vital for maintaining product integrity. In industries like pharmaceuticals and semiconductor manufacturing, even tiny particles can cause major defects. For example, an ISO Class 5 cleanroom allows up to 100,000 particles per cubic meter, which may be acceptable for some industries but could compromise sterile drugs or microchips. Proper classification ensures that the environment is controlled to prevent contamination, safeguarding the quality of sensitive products.
Many industries must meet stringent standards to stay compliant. For example, the pharmaceutical industry follows Good Manufacturing Practice (GMP) and ISO standards to ensure the safety of medications. These regulations specify the cleanroom class needed based on the nature of the product. A cleanroom that doesn’t meet the required class may not pass inspections from regulatory bodies like the FDA or European GMP, leading to penalties or product recalls.
Choosing the wrong cleanroom classification can have serious consequences. If a cleanroom isn't stringent enough, contamination may occur, resulting in defective products. In industries such as medical device manufacturing or drug production, this could endanger patients' health. Additionally, failing to meet regulatory standards could lead to costly fines, lawsuits, and loss of business reputation. Ultimately, the wrong classification can jeopardize both product safety and a company's financial stability.
Choosing the right cleanroom classification is essential for meeting industry standards, ensuring product quality, and maintaining compliance. Below, we break down which ISO classifications are best suited for various industries.
ISO Class 5 or 6 cleanrooms are ideal for sterile manufacturing processes in the pharmaceutical and biotechnology sectors.
Why These Classifications Are Crucial for Medicine Safety Sterility is a top priority for injectable drugs, vaccines, and other pharmaceutical products. ISO Class 5 ensures minimal particle contamination, which is vital to prevent harmful contaminants from compromising patient safety.
For chip fabrication and microprocessor production, ISO Class 2 or 3 cleanrooms are a must.
How Strict Particle Control Ensures Functional Components A single particle can ruin a semiconductor. These cleanrooms maintain ultra-low particle counts to preserve the integrity and functionality of electronic components during manufacturing.
ISO Class 5 to 7 cleanrooms are commonly used for satellite assembly and aerospace component testing.
Why Cleanroom Quality Impacts Aerospace Safety Contaminants can seriously affect satellite performance. By ensuring strict particle control, these cleanrooms protect sensitive components from contamination that could impact functionality.
ISO Class 4 or 5 cleanrooms are required for producing implantable devices and medical tools that come into direct contact with the human body.
Ensuring Patient Safety Through Stringent Cleanroom Standards Medical device contamination can have severe consequences for patients. Cleanroom standards ensure that devices are manufactured in a contamination-free environment, safeguarding public health.
For industries like food packaging and cannabis production, ISO 7 or 8 cleanrooms are common.
Why Cleanroom Standards Are Important in Food Packaging Even in food packaging, maintaining a clean environment is essential to prevent contaminants that could compromise product quality. Cleanroom standards help keep food safe and fresh throughout the process.
Each industry has unique contamination sensitivities. For example, semiconductor manufacturing requires ISO Class 1 or 2 to ensure microchip integrity. On the other hand, food packaging can operate within ISO Class 6 or 7.
To determine the necessary cleanroom class for your industry, evaluate the level of contamination your processes can tolerate. The more delicate your product or process, the stricter the cleanroom requirements. For instance, industries like pharmaceuticals and biotechnology often need Class 5 or higher to avoid product contamination.
Regulations such as FDA, EU GMP, and ISO 14644-1 dictate cleanroom standards to ensure safety and product quality. Adhering to these standards is critical for compliance. Failing to meet the necessary cleanroom class can result in costly delays, recalls, or loss of certification.
For pharmaceutical manufacturers, ISO Class 5 cleanrooms are often required to ensure sterile conditions. Similarly, industries like aerospace and electronics have specific contamination control standards that align with higher ISO classes to protect sensitive products.
Maintaining a highly controlled environment can be expensive, particularly with stricter ISO classifications. While cleanrooms with lower classes (such as ISO 7 and 8) are less costly to maintain, they may not be suitable for all industries.
When choosing the right classification, balance cleanliness needs with your budget. For example, while ISO Class 5 may be necessary for pharmaceutical production, it could be overkill for less sensitive processes like packaging. Consider operational efficiency and long-term costs when selecting a cleanroom class that aligns with both cleanliness and financial constraints.
When considering cleanrooms, you’re not limited to traditional designs. There are different types that cater to specific needs, ensuring industries get the environment they require for optimal product quality. Let’s explore some of these options.
Modular Cleanrooms These are prefabricated units that are easy to install and modify. They are ideal for businesses needing flexibility, as they can be expanded or relocated based on future needs. Modular cleanrooms are cost-effective and quick to set up, making them perfect for companies with changing or temporary cleanroom requirements.
Hardwall Cleanrooms Unlike modular units, hardwall cleanrooms have rigid walls, offering superior environmental control. These cleanrooms are more durable and reliable, making them suitable for industries with high-precision demands. However, they are less flexible and usually cost more to set up.
Softwall cleanrooms use flexible plastic curtains to create a controlled environment. These cleanrooms are easy to assemble and relocate, making them perfect for less critical applications or temporary setups. Softwall cleanrooms are more affordable and commonly used in industries like assembly, research, and light manufacturing.
Some industries require cleanrooms that control both particle levels and moisture. Dry rooms are essential in sectors like lithium battery production, where low humidity is crucial to prevent moisture damage. These rooms use specialized HVAC systems to maintain ultra-low humidity, often below 1% relative humidity.
Clean zones or mini-environments are localized cleanrooms used over specific equipment or processes. They offer targeted contamination control without the need for a full cleanroom. These are often used for isolated tasks like robotic workstations or critical equipment in electronics manufacturing. They’re cost-effective and efficient for controlling contamination in specific areas.
The design of a cleanroom directly influences its classification. Airflow systems, filtration technologies, and building materials all play a significant role in ensuring that the cleanroom maintains the required cleanliness levels.
Airflow Systems: The type of airflow system—whether unidirectional (laminar) or non-unidirectional—determines how effectively particles are removed from the air. For example, laminar flow systems are commonly used in high-class cleanrooms (ISO 1-3) where strict contamination control is critical.
Filtration Systems: High-efficiency particulate air (HEPA) and ultra-low particulate air (ULPA) filters are used to capture airborne contaminants. The choice of filters depends on the classification, with higher-class cleanrooms requiring more advanced filtration systems.
Construction Materials: Smooth, non-shedding materials are essential in cleanroom construction. Floors, walls, and ceilings must be easy to clean and should not contribute to particle generation. Common materials include stainless steel and acrylic, as they resist dust accumulation and are easily sanitized.
To ensure a cleanroom remains within its designated classification, regular maintenance and monitoring are essential. Frequent inspections and tests guarantee that the environment continues to meet its cleanliness requirements.
Particle Count Monitoring: Cleanrooms need continuous monitoring for airborne particles. Particle counters check the concentration of contaminants in the air at various sizes, ensuring the room maintains its classification.
Airflow Assessments: Airflow patterns must be tested regularly to ensure proper ventilation and removal of particles. Any deviation in airflow could lead to contamination risks.
Scheduled Inspections: Cleanrooms require periodic inspections to ensure compliance. This includes testing particle levels, airflow, and pressure differentials. These tests are conducted to verify that the cleanroom remains effective and meets industry-specific standards.
Choosing the right cleanroom classification is crucial for product quality and regulatory compliance. The design and maintenance of cleanrooms ensure they meet required standards. Factors like airflow, filtration, and materials affect the classification level. Regular monitoring of particles and airflow helps maintain the cleanroom's effectiveness. Understanding these aspects will help you select the right cleanroom for your industry.
A: Different industries have specific cleanroom classification needs. Pharmaceuticals generally require ISO 5, while medical devices need ISO 4 or 5 for safety. Semiconductor manufacturing demands ISO 2 to protect chip integrity.
A: Biotechnology often needs ISO 5 for high precision, while aerospace manufacturing usually requires ISO 5 or ISO 7 to prevent contamination in critical components.
A: Food production typically requires ISO 7 or ISO 8, while electronics assembly often needs ISO 3 for contamination control and product integrity.
