ISO certified cleanroom manufacturing is used in numerous industries due to the ability of the cleanroom to filter out various types of pollutants. ISO class 8 cleanrooms are one of the most common cleanroom standards and are suitable for use in the medical, industrial, and electronics industries. While cleanroom manufacturing offers many benefits, it is important to know when cleanrooms should be used. Our team has outlined the basics of cleanroom manufacturing so you can determine if it is right for you.

What is ISO Class 8 Cleanroom Manufacturing?

ISO class 8 cleanrooms filter out pollutants that may impact the safety and function of various products. These cleanrooms are required to have 20 air changes per hour and have less than 29,300 particles/meter3 that are greater or equal to 5 microns. To put it into perspective, this standard is ten times cleaner than the air that is circulated in a traditional conditioned office space.

During the manufacturing process, air filters are used to remove unwanted airborne particles. Additionally, proper cleaning, maintenance, and operational procedures must be followed while in the cleanroom to prevent contamination. So, while the process of plastic extrusion doesn’t change, there are many factors that go into making sure the cleanroom maintains the standards needed to create certain products.

What Industries Use Cleanroom Manufacturing?


The medical industry is heavily regulated to protect the health and safety of patients and healthcare providers. Profile extrusion is commonly used to create products for the medical industry, so cleanroom manufacturing is a must.

Since plastics are used in the medical industry due to their flexibility, cost-effectiveness, biocompatibility, and chemical resistance, plastic extrusion is common. Cleanroom extrusion manufacturing is used to create surgical instruments, IV tubing, catheter tubing, syringes, and more.

Sustainable Energy

Solar cells and the components involved in solar cells need to be created in an environment where particles will not cause disruptions to their functionality. This is where cleanroom manufacturing comes into play.

Many times, critical electrical components used in sustainable energy systems need to be created in cleanrooms so they do not come into contact with any particles or contaminants that may impact their function. For example, crosshead extrusion is a common manufacturing process used to encapsulate wires for these applications. The process is completed within an ISO certified class 8 cleanroom to ensure proper function.

When Should You Use Cleanroom Manufacturing?

If you need products for the medical industry, it is likely that you will need to find a manufacturer with cleanroom capabilities. Since these products are likely to come into contact with both patients and healthcare providers, they need to be sterile and avoid potentially harmful contaminants during production.

There are many other applications that may require the use of a cleanroom. If you are creating a product where a small particle may impact the quality of the product, you should consider cleanroom plastic extrusion. Some of these applications include critical applications such as aerospace, automotive, defense, and optics.

Custom Profile Has the Ability to Take On Your Cleanroom Manufacturing Projects

At Custom Profile, we strive to provide our customers with all of the plastic extrusion services they need for their projects to be successful. For the past 30 years, we have been producing high-quality products for a range of industries through co-extrusion, dual durometer co-extrusion, tri-extrusion, crosshead extrusion, and tubing extrusion.

Additionally, we have the ability to help you design and create the extrusion die and tooling needed for your project. Once production is complete, our team will assemble and finish your products so they look and function exactly as you imagine. Plus, at our Juarez, Mexico location, we have an ISO certified class 8 cleanroom so we can take on your critical projects.

Reach out to our team today to see what we can do for you.