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What is an ISO 14644 Clean Room?

2025-08-11

ISO 14644 is the international standard that defines clean room classifications and requirements. It establishes standardized protocols for controlling airborne particulate contamination in controlled environments across industries like pharmaceuticals, electronics manufacturing, biotechnology, and food processing.

Key Aspects of ISO 14644 Clean Rooms

Classification System

Rates clean rooms from ISO Class 1 (most stringent) to ISO Class 9 (least stringent)
Based on maximum allowable particles per cubic meter by size (0.1μm to 5μm)

Critical Requirements

Air filtration (typically HEPA or ULPA filters)
Air change rates and airflow patterns
Pressure differentials between zones
Temperature and humidity controls
Monitoring and validation procedures

Compliance Components

Regular particle counting tests
Airflow velocity and uniformity checks
Filter integrity testing
Recovery testing (how quickly room cleans after contamination)

Why ISO 14644 Matters for Food Processing

While originally developed for semiconductor manufacturing, ISO 14644 standards have become crucial for food production because:

Provides measurable benchmarks for cleanliness
Helps prevent microbial contamination
Supports compliance with food safety regulations (GMP, HACCP)
Reduces product recalls and quality issues

ISO Clean Room Classes Relevant to Food Industry

ISO Class	Max Particles/m³ (≥0.5μm)	Typical Food Applications
ISO 5	3,520	Aseptic packaging, sterile products
ISO 7	352,000	Ready-to-eat meals, dairy processing
ISO 8	3,520,000	Packaging areas, dry goods handling

Prefab Cleanroom

Air Shower

Pass Box

Fan Filter Unit

Downflow Booth

Air Filter

Air Filter Hepa Box

Fresh Air Cabinet

Laminar Flow Hood

Laminar Flow Ceiling

Laboratory Equipment

Fume Hood

Laboratory Bench

Laminar Flow Clean Bench

Biological Safety Cabinet

Stainless Steel Equipment

Pharmaceutical Equipment

Industrial Water Treatment Equipment

What is an ISO 14644 Clean Room?