Cleanroom Standards: ISO vs. GMP | Key Differences Explained
Cleanroom Standards: ISO vs. GMP
Cleanrooms are used across a wide range of industries—from pharmaceuticals and biotechnology to electronics and aerospace. Two of the most widely referenced cleanroom standards are ISO 14644 and GMP (Good Manufacturing Practice). Although both frameworks aim to reduce contamination, they operate with different scopes, objectives, measurement rules, and compliance requirements.
This comprehensive guide explains the differences between ISO and GMP cleanrooms, helping facility owners, project managers, and manufacturers choose the right system for their production needs.
What Is ISO 14644?
ISO 14644 is an international cleanroom standard primarily focused on environmental cleanliness measured by airborne particulate concentration. It applies to industries such as electronics, optics, aerospace, battery manufacturing, and precision engineering.
- Defines cleanroom classes (ISO 1–9)
- Concentration-based particle limits
- Focuses on environmental control, not process workflows
- Emphasizes testing and monitoring frequencies
What Is GMP?
GMP (Good Manufacturing Practice) includes cleanroom standards used in pharmaceuticals, medical devices, biotechnology, and sterile manufacturing. GMP covers not only environmental cleanliness but also production workflow, equipment procedures, documentation, and personnel behavior.
- Defines Grades A, B, C, and D
- Controls both viable and non-viable contamination
- Strong emphasis on process validation and documentation
- Regulated heavily by government health authorities
ISO Cleanroom Classification vs. GMP Grades
ISO classifications are based purely on particle concentration, whereas GMP grades consider both particle levels and operational procedures.
| ISO Class | Approx. GMP Grade | Application Notes |
|---|---|---|
| ISO 5 | Grade A/B | Sterile operations, aseptic filling |
| ISO 7 | Grade C | Support areas for critical manufacturing |
| ISO 8 | Grade D | General pharmaceutical cleanrooms |
Key Differences Between ISO and GMP Cleanrooms
1. Scope and Purpose
ISO focuses on environmental particle concentration. GMP includes environmental control plus strict process, documentation, personnel, and equipment regulations.
2. Compliance Requirements
ISO is applied voluntarily or based on industry needs. GMP is legally enforced by government agencies such as FDA and EMA.
3. Monitoring and Validation
ISO requires periodic cleanroom testing, while GMP mandates continuous environmental monitoring, extensive validation, SOPs, and full traceability.
4. Contamination Type
ISO: primarily non-viable particles
GMP: viable + non-viable contamination
5. Documentation
ISO documentation is relatively simple, while GMP requires detailed logs, batch records, deviations, CAPA, and audit trails.
Which Standard Should You Choose?
- Electronics / Aerospace / Lithium Battery: ISO cleanrooms
- Pharmaceutical / Sterile Packaging / Biotech: GMP cleanrooms
- Hybrid production: Combination of ISO + GMP zones
Farclean Cleanroom Solutions
Farclean provides professional cleanroom design, construction, validation, and equipment for both ISO and GMP environments. Our engineering team helps you meet global compliance while optimizing operational efficiency, energy consumption, and lifecycle performance.
