What is Cleanroom Manufacturing?
A cleanroom is instrumental in creating a controlled environment where pollutants like dust, airborne microbes, and aerosol particles can’t disrupt the manufacturing process.
Cleanrooms are used for a wide range of manufacturing and scientific projects, including industrial, electronics, aerospace, and medical packaging processes that require high levels of scrutiny and care.
The main job of a cleanroom is to stop pollutants, particles, and contaminants from disrupting the manufacturing process. Cleanrooms give those operating the room total control of the environment where they’re working, allowing for the adjustment of temperature, airflow, and humidity in accordance with unique project needs.
Because of these strict limitations and guidelines, common project materials such as pencils, paper, and even many typical fabrics made from natural fibers aren’t allowed within the space.
Common Cleanroom Manufacturing Projects
Whenever you’re manufacturing something that might be easily affected by contaminants or air particles, you should be operating in a cleanroom with proper protocols. There are also industry standards specific to medical packaging that require cleanroom facilities to be used.
These are a few markets within the medical industry where our team frequently utilizes cleanroom manufacturing:
- Spinal and Biologics
Cleanrooms are classified into levels of contamination, a classification that depends on the number of particles allowed in the space, per cubic meter. Different products and devices will require varying levels of cleanroom classification to be manufactured, so you need to check with your manufacturer to ensure that they have the proper facilities to take on your project.
At Janco, our facilities include ISO-certified class 7 and class 8 cleanrooms used for forming, packaging, and assembly projects. Our cleanroom manufacturing facilities are FDA registered, and ISO 13485 & ISO 14464-1 certified. Our full range of certifications include:
- High Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
- Low Volume Thermoforming ISO 14644-1 Cleanroom Certification-Class 8
- Packaging ISO 14644-1 Cleanroom Certification-Class 7
- Medical Device Assembly ISO 14644-1 Clean Room Certification- Class 8
- Foam Die Cut/Assembly ISO 14644-1 Clean Room Certification- Class 8
- ISO 13485 Certification
- FDA Registered Facility
Have a project that requires Cleanroom Manufacturing?
Get in touch with Janco to learn more about how our team can help.