The required cleanroom standards for the United States and Europe are very similar with slight differences. The main cleanroom standard that is required and recognized by the both U.S. and Europe is ISO 14644-1 The main difference is that European Standards require CE certification for the electrical components, while the U.S. Standards require UL-Certification. Our prefabricated and modular ISO Cleanrooms are certified by UL for both the electrical components and the construction codes for each city and state.
ISO 14644-1:2015 establishes the air purity classifications related to the concentration of airborne particles in cleanrooms and clean zones. Only the particle counts ranging from 0.1 µm to 5 µm are considered for this classification.
USP 797/800 Cleanrooms are used for compounding pharmacies, and typically require ISO 7 compounding rooms, gloveboxes, and ISO 8 gown rooms. The prefabricated modular cleanrooms are a great solution for the wide variety of USP 797/800 cleanroom sizes and types.
In addition, a CBD Extraction cleanroom is mandatory for CGMP practices that are FDA regulated. The main features of this type of cleanroom include;
ISO 7 or ISO 8 Cleanrooms with HEPA Fan Filter Units to filter the air in the space, gowning room with airlock while donning the disposable cleanroom apparel. Sensors to measure the air pressure of the cleanroom and the ambient.
ISO 14644-1 Cleanroom Standards
Cleanrooms are mainly used in the manufacturing of equipment and scientific research. A cleanroom is a controlled environment with low levels of contaminants such as dust, airborne microorganisms, aerosol particles, and chemical fumes.
More specifically, clean rooms have controlled contamination levels. This is indicated by the number of particles per cubic meter for a given particle size. Outdoor air in a typical urban environment contains 35,000,000 particles per cubic meter with a diameter of 0.5 microns or larger. This corresponds to ISO 9 cleanrooms, the lowest level of cleanroom standards.
ISO 1: This is the cleanest cleanroom option with the lowest particulate count which requires no more than 1.0 microns and no more than 2 particles per cubic meter that are larger than 0.3 microns. This ISO 1 standard is used in life science and electronic companies where nanotechnology is used with ultra-fine particulate processing. The standard air changes per hour for an ISO 1 cleanroom is 500 to 750 and the ceiling coverage is 100 percent. ISO 1 specification typically uses ULPA filtering. Other popular features include 100% ULPA ceiling coverings and raised floors. The cleanest of cleanroom classifications
ISO 2: The second most clean option which requires less than 11 particles larger than 0.3 microns per cubic meter and no particles greater than 1.0 microns. ISO 2 cleanrooms typically have 500-750 air changes per hour and use ULPA filters. Other popular features include 100% ULPA ceiling coverings and raised floors. is the second cleanest category
ISO 3: The ISO 3 cleanroom specification requires no more than 102 particles larger than 0.3 microns and no more than 8 particles larger than 1.0 microns per cubic meter. In an IS0 3 cleanroom typically ULPA filtration is used with 500–750 air changes per hour. Additionally, typical traits are elevated floors and 100% ULPA filtering and ceiling coverage. This is the third cleanest classification of cleanrooms. ISO 3 cleanroom is considered as class 1 (or, 1 particle per cubic foot).
ISO 4: The ISO 4 cleanroom criteria requires less than 1020 particles larger than 0.3 microns and no more than 2 particles larger than 5.0 microns per cubic meter. ULPA filtration is commonly used, which typically has 500–600 air changes per hour. 100% ULPA ceiling coverage and raised floors are additional features that are typical. This class 10 (or, 10 particles per cubic foot) is the fourth cleanest cleanroom in the ISO categorization.
ISO 5: The ISO 5 cleanrooms must have 250–300 HEPA-filtered air changes per hour and less than 3,520 particles larger than 0.5 microns per cubic meter. Class 100 (or, 100 particles per cubic foot) is the equivalent FED standard. Pharmaceutical filling rooms and semiconductor manufacturers typically use this type of cleanroom in their organizations.
ISO 6: This ISO 6 cleanroom must have 180 HEPA-filtered air changes per hour and less than 35,200 particles larger than 0.5 microns per cubic meter. Class 1000 (or, 1000 particles per cubic foot) is the equivalent FED standard.
ISO 7: The ISO 7 cleanroom must have 60 HEPA-filtered air changes per hour and less than 352,000 particles larger than 0.5 microns per cubic meter. Class 10,000 (or, 10,000 particles per cubic foot) is the corresponding FED standard. Pharmacy USP 800, compounding rooms, electronics production facilities, and medical device manufacturers typically use this type of cleanrooms.
ISO 8: The ISO 8 cleanrooms are the least clean cleanroom classification. This type of cleanroom has less than 35,200,000 particles greater than 0.5 microns per cubic meter. The required HEPA-filtered ventilation is 20 times per hour. By comparison, typical office space is 5-10 times dirtier. The corresponding FED standard is Class 100,000 (or, 100,000 particles per cubic foot). Common applications include plastic extrusion for medical devices, e-liquid manufacturing, nutritional supplement packaging, and manufacturing assembly lines.
ULPA Filters vs. HEPA Filters: ULPA (Ultra-Low Particulate Air) filters trap more small particles than HEPA (High-Efficiency Particulate Air) filters.
ULPA filters are 99.999 times more efficient at removing submicron particulate matter with a diameter of 0.12 microns or larger, while HEPA filters are 99.97 times more efficient at removing particulate matter with a diameter of 0.3 microns or larger.
Contact us today at info@trustmedically.com to get started with your custom-made, prefabricated, and modular cleanroom projects that are ISO and UL certified.
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