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TS 11605 EN ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
The standard for cleanrooms and associated controlled environments has been prepared to control airborne particle contamination, ensuring that contamination levels remain within acceptable limits for critical activities.
Industries such as aerospace, microelectronics, pharmaceuticals, medical devices, food, and healthcare, which benefit from air contamination control, are included in the scope of this standard.
The TS 11605 EN ISO 14644-1 standard defines air cleanliness classification using ISO classification limits for cleanrooms and associated controlled environments. In addition to determining the concentration of airborne particles, it also outlines the standard testing methods.
The TS 11605 EN ISO 14644-1 standard specifies particle size ranges designed for classification purposes to determine the concentration limits for particles. The standard also outlines the protocols for determining and designing cleanliness levels based on particles that are larger or smaller than the particle size range defined in the classification.
This standard is one of the standard series related to cleanrooms and contamination control.
In the design, definition, use, and control of cleanrooms and other controlled environments, the factor of cleanliness from airborne particles, along with many other factors, should be considered. These are detailed in other sections of international standards prepared by ISO/TC 209.
In some cases, additional methods and restrictions may be provided by competent regulators. In such cases, appropriate adaptations of the standard testing procedures may be necessary.
The TS 11605 EN ISO 14644-1 standard specifically applies to the classification of air cleanliness in cleanrooms and associated controlled environments, particularly based on airborne particle concentration. The classification is based on particle populations that only show cumulative distribution within the specified size range, from 0.1 µm to 5 µm (the lower threshold). Particles that fall outside of the specified size range (larger than 5 µm or smaller than 0.1 µm) are not included in the classification process.
For very small particles (smaller than 0.1 µm) and macro particles (larger than 5 µm), concentrations can be determined using the U and M identifiers, respectively.
The TS 11605 EN ISO 14644-1 standard does not address the physical, chemical, radiological, or permeable structures of airborne particles. Due to increases in size distribution, the final concentration distribution of particles is not predictably determinable and typically varies over time.
Cleanroom: A room where the entry, formation, and retention of particles are minimized, and where the concentration of airborne particles, along with other parameters such as temperature, humidity, and pressure, are controlled as required.
DEMONSTRATING COMPLIANCE
Customer: By conducting the agreed-upon testing procedures, and providing the corresponding documentation related to the results and test conditions, compliance with the air cleanliness requirements (ISO class) set by the customer is verified.
Tests: To demonstrate compliance, cleanroom analyses must be performed. If no consensus method exists or no method has been determined, a reference method can be used, and a comparably clear alternative method may also be applied. Tests to verify compliance must be conducted using calibrated equipment.
TS EN ISO 14644-2 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: TESTING AND MONITORING REQUIREMENTS FOR CONTINUOUS COMPLIANCE WITH ISO 14644-1
The TS EN ISO 14644-2 standard provides a process to ensure continuous compliance with ISO 14644-1 and specifies the minimum requirements for testing and monitoring. Specific conditions related to operations and risk assessment of the installation must be taken into account.
Cleanrooms and controlled environments ensure the control of airborne particle contamination to define suitable levels for pollution-sensitive activities. Industries benefiting from contamination control include aerospace, microelectronics, pharmaceuticals, medical devices, health, food, and more. Besides particle cleanliness, many factors must be considered in the design, specification, operation, and control of cleanrooms and other controlled environments. In some cases, additional policies and restrictions may be imposed by regulators.
In such situations, appropriate adaptations of the standard testing procedures may be required.
The TS EN ISO 14644-2 standard specifies the conditions for periodic testing required to demonstrate continuous compliance with the air cleanliness (ISO class) of cleanrooms and controlled areas. These conditions refer to the tests outlined for the classification of cleanrooms and controlled environments in ISO 14644-1.
Additional tests for compliance are specified in this standard. Optional tests that may be performed at the user's discretion are also included. The TS EN ISO 14644-2 standard also covers the conditions for monitoring to demonstrate continuous compliance with the air cleanliness of cleanrooms and controlled environments.
Re-evaluation of Compliance: Based on the cleanroom classification, a series of tests must be conducted to demonstrate compliance with ISO 14644-1. Verification of pre-test conditions is included.
Tests: The following tests are typically performed for a cleanroom or its components to determine performance:
• Air particle measurement at specified points according to the cleanroom condition.
• Air microbiological measurements (total bacteria, mold-yeast) taken from the same points.
• Microbiological test samples from the hands of the staff (total coliforms, E. coli, S. aureus).
• Microbiological test samples from surfaces such as cleanroom entrances, cleanroom interiors, material entry points (total bacteria, total coliforms, E. coli).
• Microbiological test samples from surfaces in the cleanroom, especially those in contact with products (equipment, material boxes, etc.) (total bacteria, total coliforms, E. coli).
Monitoring: Monitoring is the observation activity conducted through measurements and analysis to gather evidence about the performance of a facility. Monitoring data can be used as an indicator of the facility's condition and help determine the frequency of tests.
Periodic Intervals for Cleanroom Measurements and Analysis
• Continuous: Ongoing updates that occur continuously.
• Frequently: Updates that occur at intervals not exceeding 60 minutes during operation.
• 6 months: Updates that occur at an average interval not exceeding 183 days during operation.
No interval should exceed 190 days.
• 12 months: Updates that occur at an average interval not exceeding 366 days during operation.
No interval should exceed 400 days.
• 24 months: Updates that occur at an average interval not exceeding 731 days during operation.
No interval should exceed 800 days.
Demonstrating Continuous Compliance: Continuous compliance with the air cleanliness requirements (ISO class) of the facility is verified through the completion of the specified tests and documentation of the results. Monitoring data can be used to determine the frequency of required tests.
Tests for Continuous Compliance: The maximum time intervals between these tests for continuous compliance with the specified ISO class are as follows:
< ISO Class 5 every 6 months (Particle) Monthly (Air Microbiology)
< ISO Class 5 every 12 months (Particle) Every 3 months (Air Microbiology)