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Comprehensive
Guide to
Cleanroom
Classification &
Standards
Cleanroom Classification & Standards: A Comprehensive Guide
Cleanrooms are essential for maintaining contamination control and cleanliness in various industries, such as
pharmaceuticals, biotechnology, medical devices, and electronics manufacturing. To ensure that cleanrooms meet the
necessary requirements, different classifications and standards have been developed. In this comprehensive guide, we
will explore the most widely used cleanroom classification systems and stanards, including ISO 14644-1, EU GMP, USFed
209E, and BS 5295.
ISO 14644-1 Cleanroom Classification
ISO 14644-1 is an international standard for cleanroom classification that provides a consistent method for classifying
cleanrooms based on airborne particle concentration. The standard defines nine classes, ranging from ISO 1 (the
cleanest) to ISO 9 (the least clean), with specific requirements for each class.
Key features of ISO 14644-1 classification:
1.
Particle concentration-based classification.
2.
Nine classes from ISO 1 to ISO 9.
3.
Widely adopted across various industries.
EU GMP Cleanroom Classification
The European Union’s Good Manufacturing Practice (EU GMP) guidelines classify cleanrooms into four grades: A, B, C,
and D. These grades correspond to the cleanliness level required for different activities in pharmaceutical
manufacturing, ranging from the most stringent conditions for aseptic processing (Grade A) to less stringent conditions
for less critical operations (Grade D).
Key features of EU GMP classification:
1.
Four grades:A, B, C, and D.
2.
Based on requirements for different manufacturing activities.
3.
Focused on pharmaceutical and biotechnology industries.
US Fed 209E Cleanroom Classification
The US Federal Standard 209E (Fed 209E) defined six classes of cleanrooms, ranging from Class 1 (the cleanest) to Class
100,000 (the least clean). Although it has been superseded by ISO 14644-1, some industries still refer to Fed 209E due to
historical reasons or familiarity with the standard. The classification is based on airborne particle concentration.
Key features of US Fed 209E classification:
1.
Six classes: Class 1 to Class 100,000.
2.
Particle concentration-based classification.
3.
Superseded by ISO 14644-1 but still referenced in some industries.
BS 5295 Cleanroom Classification
The British Standard BS 5295 is a cleanroom classification system primarily used in the United Kingdom. It defines four
classes, ranging from Class 1 (the cleanest) to Class 4 (the least clean). BS 5295 is based on airborne particle
concentration and additional factors such as air pressure differentials and air change rates.
Key features of BS 5295 classification:
1.
Four classes: Class 1 to Class 4.
2.
Based on particle concentration and additional factors.
3.
Primarily used in the United Kingdom.
Understanding cleanroom classifications and standards is essential for maintaining the quality and compliance of your
controlled environment. For more information or assisitance in selecting the right cleanroom classification for your
specific needs, contact our team of experts. We’re here to help you maintain the highest standards of cleanliness and
contamination control.
