How to Choose the Right ISO Classification for Your Cleanroom
Cleanrooms are essential for industries like biotechnology, pharmaceuticals, aerospace, and electronics, where controlling contamination is critical to product quality and safety. Choosing the right ISO classification for your cleanroom is one of the most important decisions in designing or selecting a facility. It directly impacts your ability to meet regulatory requirements, maintain product integrity, and optimize costs.
In this blog, we’ll break down the factors to consider when choosing the appropriate ISO classification for your cleanroom, ensuring it aligns with your industry needs and operational goals.
What Is ISO Classification?
ISO classification, as defined by ISO 14644-1, categorizes cleanrooms based on the number and size of particles permitted per cubic meter of air. The classifications range from ISO Class 1 (the cleanest) to ISO Class 9 (the least stringent). The lower the class number, the stricter the contamination control requirements.
Key Parameters:
Particle size: Measured in microns (e.g., 0.1 µm, 0.5 µm).
Particle count: Maximum allowable number of particles per cubic meter of air.
Common ISO Classifications and Their Applications
ISO Class 1–3: Ultra-clean environments for advanced applications such as semiconductor manufacturing and nanotechnology.
Example: Microelectronics, nanotechnology.
ISO Class 4–5: High-level cleanliness for critical processes in pharmaceuticals and biotechnology.
Example: Aseptic filling, cell therapy, gene therapy.
ISO Class 6–7: Moderate cleanliness for general pharmaceutical production and medical device assembly.
Example: Sterile medical device manufacturing, secondary pharmaceutical packaging.
ISO Class 8–9: Basic cleanliness for less sensitive operations.
Example: General laboratory work, warehouse areas.
Factors to Consider When Choosing ISO Classification
1. Industry Requirements
The industry you operate in dictates the level of cleanliness required for compliance. For example:
Pharmaceuticals: Requires stringent cleanliness (ISO Class 5 or 7) for sterile drug production.
Biotechnology: Demands high cleanliness (ISO Class 5 or 6) for cell culture and biologics.
Electronics: Requires ultra-clean environments (ISO Class 1–3) to prevent defects in microelectronics.
2. Regulatory Compliance
Understand the specific regulations governing your industry, such as:
FDA cGMP (Current Good Manufacturing Practices): Mandates cleanliness for pharmaceutical and medical device production.
EU GMP Standards: Aligns cleanroom grades with ISO classifications.
ISO 13485: Requires compliance for medical device manufacturers.
3. Product Sensitivity
The level of cleanliness depends on how sensitive your products are to contamination:
High Sensitivity: Products like injectables, gene therapies, and semiconductors need ISO Class 5 or better.
Moderate Sensitivity: Products such as implantable medical devices or sterile dressings may require ISO Class 7.
Low Sensitivity: General packaging and storage often align with ISO Class 8–9.
4. Budget and Cost Considerations
Higher-class cleanrooms are more expensive to design, construct, and maintain. Costs increase due to:
More frequent air changes per hour (ACH).
Higher energy consumption for HVAC systems.
Advanced filtration systems like HEPA/ULPA filters.
Ensure the classification matches your needs without over-engineering for unnecessary cleanliness.
5. Operational Workflow
Evaluate how your processes interact with the cleanroom environment:
Personnel and material flow: Ensure pathways are designed to reduce cross-contamination.
Process sensitivity: Match the cleanroom classification to the specific stage of your operations. For instance, aseptic filling may require ISO Class 5, while storage can be ISO Class 8.
6. Scalability
If you anticipate growth, choose a cleanroom that can accommodate future needs:
Modular designs: Allow for easy upgrades to a higher ISO classification.
Flexible layouts: Support process expansion without significant structural changes.
Steps to Determine the Right ISO Classification
Identify Process Requirements:
Outline the processes that will take place in the cleanroom.
Determine the sensitivity of products and equipment to contamination.
Understand Regulatory Standards:
Research industry-specific guidelines.
Consult regulatory bodies such as FDA, EMA, or ISO committees.
Analyze Environmental Needs:
Assess temperature, humidity, and pressure requirements.
Determine air change rates and filtration needs.
Consult Experts:
Work with cleanroom consultants or engineers to design a facility that meets your needs.
Conduct Risk Assessment:
Identify potential contamination sources and evaluate their impact.
Use this assessment to refine your choice of ISO classification.
Example Use Case: Pharmaceutical Manufacturing
Product: Injectable drugs.
Cleanroom Classification: ISO Class 5 for filling operations, ISO Class 7 for preparation areas.
Key Considerations: Regulatory compliance with cGMP, risk of microbial contamination, scalability for future production increases.
Conclusion
Choosing the right ISO classification for your cleanroom is a critical decision that impacts product quality, regulatory compliance, and operational efficiency. By considering industry requirements, regulatory standards, product sensitivity, and budget constraints, you can design or select a cleanroom that meets your specific needs.
At ThermoGenesis CleanRooms, we provide ISO-compliant cleanroom solutions tailored to your industry. Contact us today to learn how we can help you build a cleanroom that supports your operational and compliance goals.
About The Author
Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.
Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.
