ISO 8 cleanroom design requires the understanding of several methodologies and procedures that evaluate airborne contamination levels including ISO 14644-1 to ISO 14644-8, ISO 14698-1, and ISO 14698-2.
ISO 14644-1: Standardizes cleanroom air quality, classifying it into nine levels, from the very clean (ISO Class 1) to the least clean (ISO Class 9), based on the number of particles in the air.
ISO 14644-2: Methods for enumerating particles in cleanrooms, along with establishing sampling methods and protocols.
ISO 14644-3: Evaluation of filtration systems and HEPA, ULPA, and MERV filters in cleanrooms.
ISO 14644-4: Planning, building, and commissioning cleanroom facilities to meet specific standards.
ISO 14644-5: Approach to daily operations, training, and standardized procedures.
ISO 14644-6: Evaluation of tools and equipment for counting airborne particles.
ISO 14644-7: Standards for secondary equipment used in cleanrooms such as laminar flow hoods and isolators.
ISO 14644-8: Guides the assessment and ranking of in-room cleaning systems, focusing on the qualities and benefits of these specialized cleaning tools.
ISO 14644-1 | ISO 8 Cleanroom Design Standards
ISO-compliant cleanroom design ensures a rigorous and scientifically sound method to evaluate and maintain the integrity of critical environments. However, ISO standards do not explain the protocols and adaptations required for your specific facility or application. In industries where regulatory bodies enforce additional rules or constraints, modifications to testing processes and evaluation methods may be necessary.
Each cleanroom build should demonstrate a structured approach with a logical sequential flow through the design, construction, and start-up stages. Along the way, there will normally be reviews and iterations of the requirements, contamination control concepts, layouts, and other considerations. The final design should be reviewed against the requirements before construction commences and when construction is complete.
ISO 8 Cleanroom Airborne Particulate Requirements ISO 14644-1
ISO 8 cleanroom certification requires the enumeration of three particle sizes:
Under ISO 14644-1, ISO Class 8 cleanrooms do not include the evaluation of particles below ≥ 0.5 µm. Particle sampling ranges for thresholds of ≥ 0.1µm and ≥ 0.2 µm are not required.
ISO 8 GMP Grade C/D Cleanrooms
ISO 8 cleanrooms meet the requirements for two grades of GMP-rated cleanrooms:
Grade C (ISO Class 8): This classification is used for non-critical manufacturing areas where a relatively low level of cleanliness is required, such as solution preparation, powder weighing, and product filling for terminal sterilization. The maximum particle count in this type of cleanroom, during operation, is 100,000 particles per cubic foot (or approximately 3,520,000 particles per cubic meter) of air that are 0.5 microns in size or larger. However, Grade C spaces must maintain ISO 7 conditions while at rest.
Grade D (unrated): This classification defines a Clean Non-Classified (CNC), which acts as a background zone for processes such as equipment cleaning, component assembly and handling of closed, sterilized aseptic containers. As an unrated space, Grade D rooms are not expected to maintain a defined particle count during operation. However, they must maintain ISO 8 conditions while at rest.
ISO 8 Particulate Testing Interval Requirements
ISO 8 cleanrooms require annual testing and revalidation (every 12 months) to maintain ISO-accredited performance
Per 14644-2, cleanroom tests may be performed in either the operational or at-rest state. For cleanrooms that have dedicated particulate, airflow, and air pressure monitoring systems, ISO 14644-2 states that time frames may be extended, provided that the results of continuous or frequent monitoring remain within the specified limit(s).
 |
 |
 |
 |
 |
 |
 |
 |
 |