STANDARDS & REGULATIONS
Standards & Regulations
Applicable Standards
At Euroflux, all our cleanroom solutions are designed and manufactured in full compliance with international standards and best practices governing clean environments and contamination control.
Our products and installations meet the requirements of the following standards:
| NF EN ISO 14644-1 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness. Reference index: X44-101 |
| NF EN ISO 14644-2 | Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 Reference index: X44-102 |
| NF EN ISO 14644-3 | Cleanrooms and associated controlled environments Part 3: Test methods |
| NF EN ISO 14698-1 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods Reference index: X44-110 |
| NF EN ISO 14799 | Air filters for general air cleanliness Terminology Reference index: X44-001 |
| NF EN ISO 1822-1 | High-efficiency air filters (EPA, HEPA, and ULPA) Part 1: Classification, performance testing, and marking Reference index: X44-014-1 |
GMP Good Manufacturing Practices
We adhere to the Good Manufacturing Practices (GMP) issued by the French Health Products Safety Agency (ANSM) in accordance with official bulletin No. 2009/9 bis.
These practices define the quality assurance principles for the design, production, testing, and validation of equipment used in clean and controlled environments.
They ensure compliance with the highest standards of safety, traceability, and performance required in the pharmaceutical, biotechnology, medical device, and cosmetic industries.
Emerging Standards
We continuously monitor regulatory updates, including the implementation of new GMP guidelines specific to the cosmetics industry and other sectors, to ensure ongoing compliance and excellence across all our projects.
Useful Resources
ISO Official Website (https://www.iso.org)
AFNOR Official Website (https://www.afnor.org)
ANSM Official Website (https://ansm.sante.fr)
Applicable Standards
At Euroflux, all our cleanroom solutions are designed and manufactured in full compliance with international standards and best practices governing clean environments and contamination control.
Our products and installations meet the requirements of the following standards:
| NF EN ISO 14644-1 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness. Reference index: X44-101 |
| NF EN ISO 14644-2 | Cleanrooms and associated controlled environments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 Reference index: X44-102 |
| NF EN ISO 14644-3 | Cleanrooms and associated controlled environments Part 3: Test methods |
| NF EN ISO 14698-1 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods Reference index: X44-110 |
| NF EN ISO 14799 | Air filters for general air cleanliness Terminology Reference index: X44-001 |
| NF EN ISO 1822-1 | High-efficiency air filters (EPA, HEPA, and ULPA) Part 1: Classification, performance testing, and marking Reference index: X44-014-1 |
GMP Good Manufacturing Practices
We adhere to the Good Manufacturing Practices (GMP) issued by the French Health Products Safety Agency (ANSM) in accordance with official bulletin No. 2009/9 bis.
These practices define the quality assurance principles for the design, production, testing, and validation of equipment used in clean and controlled environments.
They ensure compliance with the highest standards of safety, traceability, and performance required in the pharmaceutical, biotechnology, medical device, and cosmetic industries.
Emerging Standards
We continuously monitor regulatory updates, including the implementation of new GMP guidelines specific to the cosmetics industry and other sectors, to ensure ongoing compliance and excellence across all our projects.
Useful Resources
ISO Official Website (https://www.iso.org)
AFNOR Official Website (https://www.afnor.org)
ANSM Official Website (https://ansm.sante.fr)
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