ISO 5 – ISO 8 Cleanroom Classes Explained: Modular Solutions for Medical Device, Pharma & Electronics
ISO 5 – ISO 8 Cleanroom Classes Explained: How Manufacturers Choose the Right ISO Level
A Practical Guide for Medical Device, Pharma, and Electronics Teams
Table of Contents
- Why ISO Classes Matter
- ISO Classes 5–8 Explained
- Illustrative Scenario
- Why ISO Class Impacts Cost
- Common Questions About ISO Cleanroom Classes
- Tips for Buyers
- Why Modular Hardwall Cleanrooms Are the Smart Choice
- Call to Action
Why ISO Classes Matter
ISO cleanroom classifications define air cleanliness based on the number of particles allowed per cubic meter.
Key takeaways:
- Two ISO 7 cleanrooms can perform very differently depending on layout, airflow, and pressure control.
- Your ISO class should match the process, not just the industry.
- ISO class drives construction and operating costs.
Pro Tip: Avoid selecting an ISO class based on competitors. Align it with your workflow for efficiency and cost savings.
ISO Classes 5–8 Explained
| ISO Class | Typical Uses | Cost Level | Who Uses It |
|---|---|---|---|
| ISO 8 | General assembly, packaging | $ | Startups, small manufacturers |
| ISO 7 | Medical device assembly, electronics | $$ | Scaling companies |
| ISO 6 | Microelectronics, optics, precision components | $$$ | High-precision labs |
| ISO 5 | Sterile manufacturing, implants, critical pharma processes | $$$$ | Pharma, aseptic manufacturing |
ISO 8 — The Most Common Starting Point
Ideal for general assembly, packaging, molded plastics, and labeling. Provides basic contamination control at the lowest build and operating cost.
ISO 7 — The “Workhorse”
Used for catheter assembly, electronics, adhesive bonding, and medical device production. Strong contamination control without the high cost of ISO 6.
ISO 6 — High-Precision Environments
Used for optics, microelectronics, and specialty medical components. Balances high cleanliness with manageable cost.
ISO 5 — Critical Work Only
Used for sterile manufacturing, implantable devices, and pharmaceutical aseptic operations. Often implemented as modules or laminar-flow hoods inside an ISO 7 space.
Illustrative Scenario: How Modular Cleanrooms Optimize ISO Classes
A common situation we see is manufacturers planning their cleanrooms at a higher ISO class than necessary. By aligning each workflow step with the appropriate ISO level—rather than assigning one class to the entire room—they can significantly reduce installation and operating costs. Modular cleanroom layouts make this right-sizing much easier.
Pro Tip: Modular design allows hybrid ISO zones, so critical processes get the high-level control they need without overspending on the entire space.
Why ISO Class Impacts Cost
Moving from ISO 8 to ISO 7, or ISO 7 to ISO 6, increases requirements for airflow and filtration, which can raise both construction and operating costs. ISO 5 requires specialized laminar airflow and tight control for critical processes.
Modular cleanrooms make it easier to match the right ISO class to your workflow, helping you avoid unnecessary expense while maintaining compliance.
Common Mistakes Manufacturers Make
- Overbuilding: Choosing the highest ISO class for the entire room unnecessarily
- Ignoring hybrid ISO zones for critical processes
- Not planning for future expansion
- Overlooking modular benefits in installation and upgrades
Common Questions About ISO Cleanroom Classes
Q: What ISO class is best for medical device assembly?
A: Often ISO 7 or ISO 8, depending on the criticality of your process steps.
Q: Can I have multiple ISO classes in one cleanroom?
A: Yes — modular cleanrooms make hybrid ISO zones possible, so only the critical areas need higher classifications.
Q: How do ISO classes affect cost and HVAC requirements?
A: Higher ISO classes require more filtration, tighter airflow control, and more complex HVAC systems.
Q: Why choose a modular hardwall cleanroom for ISO 5–8?
A: They are faster to install, scalable, upgradeable, and provide better air quality control than softwall alternatives.
Tips for Buyers
- Align ISO class to workflow, not competitors
- Use hybrid zones instead of overbuilding
- Modular systems allow upgrades without rebuilding the entire facility
- Consult with experts to match your ISO class to critical process steps
Why Modular Hardwall Cleanrooms Are the Smart Choice
MMBT by Metro CAD modular cleanrooms deliver:
- Faster installation
- Stable pressure control
- Expandability and upgradeability
- Lower operating costs
- Smooth, compliant surfaces ideal for ISO standards
They are perfect for manufacturers who want flexibility without overspending.
Call to Action
Choosing the right ISO class isn’t about picking a number—it’s about aligning your cleanroom to your actual process. If you want help selecting the correct ISO level or designing an expandable modular cleanroom, MMBT by Metro CAD can guide you through it.