MODULAR COLD ROOM

What is a Clean Room Environment?

A cleanroom is any controlled area where contaminants and airborne particles are highly controlled and kept within strict limits. They are used in different industries, including aerospace, healthcare, life sciences, electronics, biotech, optics, military, and other branches where substantial amounts of particles could affect manufacturing.

The High-Efficiency Particulate Air (HEPA) filter is the key component of any cleanroom. Its role is to trap all the particles larger than 0.3 microns, which represent one of the most penetrating particle sizes. According to scientists, 0.3 micron-particles tend to evade air filters more than any larger or smaller particles.

The air inside a cleanroom goes through the HEPA filter, capable of trapping even 99.97% of 0.3-micron particles. Modern HEPA filters have interlaced glass fibers twisted and turned in multiple directions to form a fibrous maze. When particles enter this web, they leave it in some of the following ways:

• Direct impaction: Dust, mold, pollen, and other types of large contaminants tend to travel in a straight path.
• Sieving direction: Sieving happens when the particle is too large to fit between the fiber spaces.
• Interception: Direct interception occurs when the particles are not large enough to have inertia or small enough to diffuse within the flow.
• Diffusion: Diffusion works on the tiniest particles. Since the air cannot hold small particles in place, they tend to diffuse within the flow stream.

While HEPA filter purifies the air quite efficiently, some cases may require Ultra Low Particulate Air (ULPA) filters. These provide next-level cleanliness in situations where it is needed

Cleanroom Fun Facts

Although the idea of cleanroom might not sound exciting at first, you’ll change your opinion once you’ve read the following cleanroom facts:

• A person standing in a cleanroom emits more than 100,000 particles per minute. To avoid potential cross-contamination, cleanroom staff must wear special garments that prevent the release of particles.
• NASA uses cleanrooms regularly to foster their space program growth, including the airflow technology and airflow development.
• Food industries use cleanrooms. More and more food industries rely on cleanrooms to manufacture products according to high sanitation standards.
• Many different types of contamination can affect the production quality. Substantial amounts of contaminants, microorganisms, and air particles may lead to product failure. Certain cleanroom supplies, such as solutions, wipes, and swabs, can reduce contamination levels.

A Brief History of Cleanrooms

Do you know when the idea of cleanroom first started and what was its initial goal?

The first cleanroom dates back to the mid-19^th century, where cleanroom environments were used in hospital operating rooms. However, the first modern cleanrooms were formed during WWII and were used to manufacture military weaponry in a safe and sterile environment. As for the HEPA filters, it is known that they were being utilized in cleanrooms by the early 1950s.

Although there are various theories regarding when and how the first cleanroom was established, it is important to remember that they appeared as an innovative solution for a severe problem – contamination.

The idea of a cleanroom has significantly evolved since its beginnings. Today, it varies in size, can have portable cleanroom design, and is used by various industries, including scientific research, software engineering, manufacturing, and more.

Cleanroom Classifications and ISO Cleanroom Standards

Cleanroom classifications refer to how clean the air is. The Federal Standard 209 of the USA states that the number of particles that equals to or is greater than 0.5 microns in one cubic foot of air is the count used to classify the cleanroom.

Cleanrooms are classified based on the numbers and size of contaminants permitted per air volume. That said, you may notice “class 10,000 clean rooms” or “class 100 clean rooms.” These signs indicate the number of 0.5micron-sized particles, or larger, allowed per cubic foot of air.

The ISO 14644-1 classification system is the primary authority in the US and Canada. It includes the following cleanroom classes: ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, and ISO 9. While ISO 1 is considered the cleanest class, ISO 9 stands for the “dirtiest” area. However, it is still much cleaner than a regular room.

Let’s take a look at the ISO cleanroom requirements table:

The most common clean room classes include ISO 5, ISO 6, ISO 7, and ISO 8.

ISO 5 Cleanroom Requirements

ISO 5 is considered a super clean cleanroom classification. ISO 5 cleanroom requirements state that the area must have less than 3,520 particles >0.5 microns per cubic meter, as well as 250-300 HEPA filtered air changes per hour. ISO 5 cleanrooms are commonly used in semiconductor manufacturing and for pharmaceutical purposes. Pristine Clean Bags® are manufactured in an ISO 5 class cleanroom in order to provide our customer’s with the highest level of cleanliness.

ISO 6 Cleanroom Requirements

ISO 6 is a very clean cleanroom. According to the ISO Class 6 cleanroom requirements, a cleanroom must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. It is commonly used in biotechnology, nanotechnology, and different cleantech manufacturing applications, including solar, film/packaging, medical device, etc.

ISO 7 Cleanroom Requirements

ISO 7 is a common clean cleanroom class. ISO 7 cleanroom requirements indicate that a cleanroom must have less than 352,000 >0.5 micron per cubic meter and 60 HEPA filtered air changes per hour. The most common ISO 7 cleanroom applications are pharmaceutical, electronic, and medical device manufacturing.

ISO 8 Cleanroom Requirements

ISO 8 is the least clean cleanroom class. According to the ISO Class 8 cleanroom requirements, the area mustn’t have more than 35,200,200 particles >0.5 microns per cubic meter. It should have 20 HEPA filtered air changes per hour. The most common uses include e-liquid manufacturing, nutraceutical packaging, and plastic extrusion for medical devices.