Explanation of cleanroom classification standards: How do ISO 14644 and GMP classes define cleanliness?

1. ISO 14644 Standard: The Global Benchmark for CleanRoom Classification

The ISO 14644 standard is internationally recognized for classifying cleanrooms based on particulate concentration per cubic meter. It divides cleanrooms into nine classes （ISO 1 to ISO 9）, with ISO 1 representing the highest cleanliness （≤2 particles ≥0.1μm per m³） and ISO 9 aligning with ordinary environments. Certification relies on particle size distribution analysis and real-time particle counting, making it critical for Semiconductor manufacturing, Electronics, and precision engineering industries.

2. gmp classifications: Pharmaceutical industry’s Unique Requirements

GMP （Good Manufacturing Practice） standards prioritize microbial control and production process risks. Its four-tier system （Grade A/B/C/D） sets Grade A as the strictest （≤3,520 particles ≥0.5μm/m³ and ≤1 CFU/m³ for viable microorganisms）. GMP mandates continuous dynamic monitoring and combines airborne/viable particle testing to prevent drug contamination. For instance, the Deiiang™ GCC® Cleanroom Solution integrates AI-powered sensors to track both particles and microbial activity simultaneously, ensuring compliance with FDA and EU GMP regulations.

3. Key Differences: Measurement Criteria and Industry Applications

The core distinctions between ISO 14644 and GMP include:

Target Contaminants: ISO focuses on non-viable particles; GMP adds microbial limits;

Industry Focus: ISO applies to industrial manufacturing, while GMP governs pharmaceuticals;

Monitoring Protocols: GMP requires 24/7 dynamic sampling, whereas ISO emphasizes initial certification. For example, Deiiang® Quality Inspector Joebo.Wang verified a Grade c CleanRoom for a vaccine producer with daily microbial tests, while an iso class 5 facility only needed quarterly audits.

4. Selecting the Right Compliance Strategy

Choosing standards depends on industry needs: ISO for electronics, GMP for life sciences. Deiiang Product Designer Jason.Peng and his team developed the modular cleanroom series, featuring customizable HVAC systems and anti-static materials. A 2023 case study showed that a biotech firm using Deiiang™ Grade A laminar flow units with Grade C zones passed unannounced EU GMP inspections within 72 hours.

In summary, both ISO 14644 and GMP define cleanliness through data-driven metrics but differ in scope and implementation. Partnering with experts like Deiiang™ – which combines certified engineering with smart monitoring – ensures compliance while optimizing operational efficiency.