Working With a Profile Extruder That Has an ISO Class 8 Environment
ISO cleanrooms are used all across the United States to manufacture medical devices, tubing, biotech devices, and more. Since ISO cleanrooms are used for such a wide range of industries and applications, there are different classifications, with ISO class 8 environments being one of the lowest levels.
These ISO cleanrooms must comply with standards that are set by the International Organization for Standardization. This gives customers the ability to know exactly what environment their products are being manufactured in. Finding a manufacturer that has an ISO class 8 environment could be beneficial or necessary for your production. Continue reading to learn more about the benefits of working with a plastic profile extruder with ISO class 8 environments.
What is an ISO Class 8 Environment?
The standards for an ISO class 8 environment include:
- A required 20 air changes per hour of HEPA-filtered air
- Less than 29,000 particles/meter3 that are greater or equal to 5 microns
Just to put those standards into perspective, air-conditioned office spaces have more than 10 times as many particles/meter3, showing just how strict the requirements are for this type of cleanroom environment.
What is Created in an ISO Class 8 Environment?
ISO class 8 environments are typically used in industries that require strict standards to be met. This includes the medical industry and industries that require critical electrical components, such as renewable energy and electronics
Medical Applications
Many medical products are created in ISO class 8 cleanrooms. Since they need to be free of contaminants in order to keep patients safe and function properly. Some of the most common medical products that are manufactured in ISO class 8 cleanrooms include IV tubing, medical device tubing and parts, surgical instruments, syringes, and more.
Renewable Energy
Renewable energy needs to function in a wide range of environments flawlessly so residents and businesses aren’t left without power. Many electrical applications, such as wire casings, need to be created in an environment without particles that could damage the wire and impact its performance.
Benefits of Working with a Plastic Profile Extruder That Has an ISO Class 8 Environment
Improved Quality, Safety, and Performance
When you work with a plastic profile extruder with ISO class 8 environment capabilities, you will experience a higher quality product with improved safety and performance. The low particle count in the cleanrooms and the reduced risk of contamination lead to better, safer products for various industries.
Ability to Serve Strict and Critical Industries
Industries that require highly precise manufacturing that can meet strict safety standards can greatly benefit from ISO class 8 environments. Plastic extruders that have ISO class 8 environments are able to provide the critical manufacturing processes that meet these standards.
Custom Profile Can Create All Types of Extrusion Dies for Your Projects
At Custom Profile, we have been providing plastic profile and tubing extrusion services for a wide range of industries since 1992. Not only are we able to offer traditional plastic profile and tubing extrusion services, but we also have the ability to complete all of our services in ISO class 8 cleanroom environments. This allows us to tackle complex projects that require strict standards to be met in critical industries like medical and renewable energy.
When you are looking for a plastic extruder that has ISO class 8 cleanroom abilities for your manufacturing process and tooling production, contact our team today to get started.