What ISO cleanroom classification is needed for your medical device manufacturing needs?

When it comes to manufacturing medical devices, maintaining a clean environment is crucial to ensure product quality and safety. MMBT by Metro CAD can provide assistance with determining the requirements for your ISO cleanroom classification needs. MMBT provides gowning room and cleanroom furniture. MMBT by Metro CAD specializes in building modular demountable wall hardwall cleanrooms, with cleanroom classifications ranging from ISO 5 to ISO 8. ISO 5 allows fewer particles in the air, which is cleaner than ISO 6, ISO 7, and ISO 8. ISO 5 is the cleanest cleanroom MMBT builds.

What Determines Clean Room Classification?

The cleanroom classification level is determined by the size of air particles that need to be targeted. Different ISO Cleanroom classes are designed to filter out specific particle sizes. For example, ISO 5 and ISO 6 cleanrooms target particles from 5 micrometers or larger down to 0.1 micrometers or larger. On the other hand, ISO 7 and ISO 8 cleanrooms target particles from 5 micrometers or larger down to 0.5 micrometers or larger.

Impact of Product and Process

The product being manufactured or the specific process taking place inside the cleanroom also plays a significant role in determining the required ISO cleanroom class level. Certain products or processes may be more sensitive to particle contamination, requiring a higher level of cleanliness. Cleanroom classification ISO 5 is more clean than an ISO 8 cleanroom classification.

For instance, products that are highly sensitive to contamination, such as medical devices or pharmaceuticals, may require a cleaner environment with a lower particle count. In such cases, an ISO 5 cleanroom would be necessary to meet the stringent cleanliness requirements.

Higher Cleanroom Class More Air Changes Per Hour

It's important to note that higher cleanroom classes, such as ISO 5, typically require more air changes per hour to maintain the desired level of cleanliness. The increased air changes help to continuously filter out particles and maintain a pristine environment for manufacturing sensitive products.

ISO 5 Cleanroom (100 PPM) Application Uses:

• Medical devices
• Cleantech manufacturing
• Pharmaceutical industry (filling rooms)
• Nanotechnology
• Biotechnology
• Semiconductor manufacturing
• Nanofabrication
• Pharmaceutical Filling
• Optics
• Surgical Equipment
• Implantable Devices

ISO 5 Cleanroom has 240-600 air changes per hour(ACPH) and uses unidirectional air flow. ISO 5 equivalent to Class 100.

Particle Sizes ISO 5 Cleanrooms Filter

ISO 5 (Class 100) Maxiumum Particles Per Cubic Meter of Air:

• 100,000 particles for sizes 0.1 micrometers or larger
• 23,700 particles for sizes 0.2 micrometers or larger
• 10,200 particles for sizes 0.3 micrometers or larger
• 3,520 particles for sizes 0.5 micrometers or larger
• 832 particles for sizes 1 micrometer or larger
• 29 particles for sizes 5 micrometer or larger

ISO 6 Cleanroom (1000 PPM) Application Uses:

• Pharmaceutical compounding
• Optical manufacturing
• Food processing and packaging
• Medical Devices
• Life Science
• Operating Rooms

ISO 6 Cleanroom has 150-240 air changes per hour(ACPH) and generally use turbulent airflow. ISO 6 equivalent to Class 1000.

Particle Sizes ISO 6 Cleanrooms Filter

ISO 6 (Class 1000) Maximum Particles Per Cubic Meter of Air:

• 1,000,000 particles for sizes 0.1 micrometers or larger
• 237,000 particles for sizes 0.2 micrometers or larger
• 102,000 particles for sizes 0.3 micrometers or larger
• 35,200 particles for sizes 0.5 micrometers or larger
• 8,320 particles for sizes 1 micrometer or larger
• 293 particles for sizes 5 micrometer or larger

ISO 7 Cleanroom (10,000 PPM) Application Uses:

• Pharmaceuticals
• Biotechnology
• Medical Devices Placed in Body
• IV Compounding
• Electronics manufacturing
• Nutraceutical Development
• Drug Compounding
• Cell Culture
• Medical Device Packaging

ISO 7 Cleanroom has 60-90 air changes per hour(ACPH) and usually use non-unidirectional airflow. ISO 7 equivalent to Class 10,000. ISO 7 targets particles sizes bigger than .5microns

Particle Sizes ISO 7 Cleanrooms Filter

ISO 7 (Class 10000) Maximum Particles Per Cubic Meter of Air:

• 352,000 particles for sizes 0.5 micrometers or larger
• 83,200 particles for sizes 1 micrometer or larger
• 2,930 particles for sizes 5 micrometer or larger

ISO 8 Cleanroom (100000 PPM) Application Uses:

• Medical device manufacturing
• Medical device assembly
• Phamaceutical Packaging
• Aerospace
• 3D Printing
• Gowning Rooms
• Plastic Injection Molding of Subcomponents
• Sterile Packaging

ISO 8 Cleanroom has 10-25 air changes per hour(ACPH) and usually do not require unidirectional airflow, which makes them more economical to build than higher class cleanrooms like ISO 5.ISO 8 equivalent to Class 100,000. ISO 8 targets particles sizes bigger than .5microns.

Particle Sizes ISO 8 Cleanrooms Filter

ISO 8 (Class 100,000) Maximum Particles Per Cubic Meter of Air:

• 3,520,000 particles for sizes 0.5 micrometers or larger
• 832,000 particles for sizes 1 micrometer or larger
• 29,300 particles for sizes 5 micrometer or larger

In conclusion, understanding the ISO cleanroom classification needed for your medical device manufacturing process is essential to ensure product quality and compliance with industry standards. By considering the particle size requirements, the product being manufactured, and the necessary air changes, you can determine the appropriate ISO class level for your specific needs.