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© PHARMACLEANSE Ltd
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Although it has been superseded by ISO 14644-1, some industries still refer to Fed 209E due to historical reasons or familiarity with the standard.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Superseded by ISO 14644-1 but still referenced in some industries.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.
Enquire Now:
0161 483 5391
© Pharmacleanse Ltd
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.