What Are the Standards Organizations That Focus on Controlled Environments?

A Comprehensive Overview of the Key Standard-Setting Organizations Dedicated to Controlled Environments

When the Federal Standard 209, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, was developed in the 1960’s the primary purpose was to distinguish an environment that controlled airborne viable and non-viable particles from other environments.

The standards provided common terminology and testing methodologies for meeting compliance. The Institute for Environmental Sciences and Technology (IEST) took the lead in developing these standards. IEST is a technical, nonprofit membership association focused on controlled environments. As the global economy expanded and more cleanrooms began operation internationally the need for an international standard arose.

Beginning in 1990, the International Organization for Standardization (ISO) formed a technical committee (ISO/TC 209) to develop the ISO 14644 cleanroom standards. The voting members of ISO/TC 209 represent 22 nations.

IEST collaborated with the International Cleanroom and Contamination Control Society (ICCCS) to write the ISO 14644 standards under the auspices of ISO/TC 209. ICCCS is a member organization for national member societies that helps facilitate international cooperation in the development, application, education, and standardization of cleanroom technology and contamination control best practices.

The IEST is the Secretariat of ISO/TC 209 and administrator of the American National Standards Institute (ANSI)-accredited U.S. Technical Advisory Group (TAG) to ISO/TC 209. The U.S. TAG to ISO/TC 209 represents the United States interests as defined in accordance with ANSI guidelines. IEST is also a founding member of the ANSI-accredited U.S. TAG to ISO/TC 229 for Nanotechnologies.

IEST Recommended Practices for Compliance

In addition to writing standards, IEST gives technical guidance through recommended practices, and education programs developed by experts in the fields of contamination control, environmental test and reliability, and nanotechnology facilities.

IEST has been writing RPs and conducting training courses for the RPs since it was established in 1953. IEST industry professional members meet twice yearly to participate in working groups on their industries' subject matter expertise. IEST develops RPs for the nanotechnology; contamination control; design, test, and evaluation; and product reliability industries.

Airborne Particulate Cleanliness

The first two standards published in the ISO 14644 series were;

• Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness (1999) and
• Part 2 -Testing and monitoring to prove continued compliance with ISO 14644-1 (2000).

These standards are considered the cornerstone of the ISO cleanroom series and were updated in 2015.

Several IEST RP’s enable end users to meet the requirements of ISO 14644-1 and -2 including:

• IEST-RP-CC001: HEPA and ULPA Filters – reference prior to selecting air filters for the cleanroom.
• IEST-RP-CC002: Unidirectional Flow Clean-Air Devices – reviews products and systems for directing air flow in the cleanroom.
• IEST-RP-CC006: Testing Cleanrooms – reviews how to perform particle testing and associated testing to achieve the desired ISO cleanliness classification.
• IEST-RP-CC007: Testing ULPA Filters – testing ULPA filters in the cleanroom.
• IEST-RP-CC019: Qualifications for Organizations Engaged in the Testing and Certification of Cleanrooms and Clean-Air Devices – provides guidelines for evaluating and selecting subcontractors to test and certify cleanrooms.
• IEST-RP-CC021: Testing HEPA and ULPA Filter Media – describes test methods for physical and filtrations properties and includes a table on filter testing frequency.
  
  

IEST publishes four technical guides to assist cleanroom operators in testing for particles:

• IEST-G-CC1001: Counting Airborne Particles for Classification and Monitoring of Cleanrooms and Clean Zones
• IEST-G-CC1002: Determination of the Concentration of Airborne Ultrafine Particles
• IEST-G-CC1003: Measurement of Airborne Macroparticles
• IEST-C-CC1004: Sequential Sampling Plan for Use in Classification of Particulate Cleanliness of Air in Cleanrooms and Clean Zones

Biocontamination Control

ISO 14698-1:2003 General principles and methods establish the principles and basic methodology of a formal system of biocontamination control for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved.

ISO 14698-2:2003 Evaluation and interpretation of biocontamination data offers guidance on evaluating microbiological data and the estimation of results obtained from sampling for viable particles. It should be used, when relevant, in combination with ISO 14698-1.

Associated recommended practices that assist cleanroom operators in achieving the principles in these standards are:

• IEST-RP-CC013: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Cleanrooms and Other Controlled Environments
• IEST-RP-CC023: Microorganisms in Cleanrooms

ISO/TC 209 members were microbiologists that also were members of the American Society for Microbiologists.

Testing

ISO 14644-3: Test Methods specifies metrology and test methods for characterizing the performance of cleanrooms and clean zones.

• IEST-RP-CC014: Calibration and Characterization of Optical Airborne Particle Counters
• IEST-RP-CC034: HEPA and ULPA Filter Leak Tests

ISO/TC 209 members were also members of NEBB, CETA and ASHRAE.

ISO 14644-4: Design, construction and start-up provides guidance for cleanroom designers, contractors, purchasers, and suppliers. A useful tool for cleanroom installers is the construction protocol included in IEST-RP-CC012: Considerations in Cleanroom Design, which addresses the design and installation of cleanroom production equipment and includes a table on cleanroom classifications, airflow velocities, and recommended number of air changes per hour.

IEST-RP-CC024: Measuring and Reporting Vibration in Microelectronics Facilities provides guidance regarding the special vibration considerations for equipment in the cleanroom.

IEST-RP-CC052: Understanding, Identifying, and Controlling Electrostatic Charge in Cleanrooms and Other Controlled Environments addresses design aspects that enable control of static electricity in cleanrooms. ISO/TC 209 members were also members of NEBB, CETA, ASHRAE and ESDA.

Cleanroom Operations

ISO 14644-5: Operations specifies basic requirements for cleanroom operations. IEST RP’s that support the basic requirements outlined in ISO 14644-5: Operations include:

• IEST-RP-CC003: Garment Considerations for Cleanrooms and Other Controlled Environments - used to select garments to protect both the product and personnel from contaminants.
• IEST-RP-CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments - used to evaluate wipers used to clean surfaces of the product and the cleanroom. Describes methods to test wiper properties. Wipers should be selected based on their intended usage.
• IEST-RP-CC005: Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments - used to select gloves to protect both product and personnel from contaminants or hazardous materials. Describes methods to test glove properties and provides guidance on donning and doffing the glove.
• IEST-RP-CC018: Cleanroom Cleaning and Sanitization: Operating and Monitoring Procedures -provides practical information regarding cleaning techniques, equipment, cleaning compounds, housekeeping, checklists, and methods for auditing housekeeping.
• IEST-RP-CC020: Substrates and Forms for Documentation in Cleanrooms - provides methods for assessing the cleanliness of items such as paper, labels, forms and similar materials.
• IEST-RP-CC026: Cleanroom Operations provides guidance to maintain the integrity of the cleanroom during operation.
• IEST-RP-CC027: Personnel Practices and Procedures in Cleanrooms and Other Controlled Environments - reviews behavior requirements for personnel working inside the cleanroom including gowning requirements.
• IEST-RP-CC032: Flexible Packaging Materials for Use in Cleanrooms and Other Controlled Environments - provides guidance for the selection of packaging materials to protect product integrity.

Minienvironments and Enclosures

ISO 14644-7: Separative Devices addressed enclosures such as barrier isolator systems, clean air hoods, gloveboxes, and minienvironments.

• IEST-RP-CC028: Minienvironments - provides guidance specifically for minienvironments in cleanrooms.

Molecular Contamination

A primary concern for any product produced in a cleanroom environment is the potential impact of airborne molecular contamination (AMC) on the product.

ISO 14644-8: Classification of airborne molecular contamination addresses airborne concentrations of specific chemical substances and provides a protocol to include test methods, analysis, and time-weighted factors within the specifications for classification.

• IEST-G-CC035: Design Considerations for AMC Filtration Systems in Cleanrooms covers HVAC system design, filter selection and the materials used to build the cleanroom.
• IEST-RP-CC016: The Rate of Deposition of Nonvolatile Residue in Cleanrooms is a reference for cleanroom certification and monitoring of nonvolatile residue.
• IEST-RP-CC031: Method for Characterizing Outgassed Organic Compounds from Cleanroom Materials and Components provides guidance for the selection of materials to assure cleanroom compatibility.

Surface Cleanliness

ISO 14644-9: Classification of surface cleanliness for particle concentration describes the classification of particle contamination levels on solid surfaces and recommends testing and measuring methods.

ISO 14644-10: Classification of surface cleanliness by chemical concentration defines the classification system for the cleanliness of surfaces in cleanrooms regarding the presence of chemical compounds or elements (including molecules, ions, atoms, and particles).

IEST-STD-1246: Product Cleanliness Levels – Applications, Requirements, and Determination, a standard for testing surfaces for contaminants, provides guidance for the selection of the test methods to demonstrate the cleanliness level required.

• IEST-RP-CC043: Surface Molecular Contamination will describe the types of surface molecular contamination (SMC) that may affect critical surfaces and processes, sources of SMC, and measurement and control methods.

Nanotechnology

ISO/TC 209 has established a nanotechnology working group to develop contamination control standards for industries involving materials and devices on the nanoscale. The four standards include classification of air cleanliness and metrology; design, construction and start-up; operations, and nanobiotechnology.

• NANO- 200: Planning of Nanoscale Science and Technology Facilities: Guidelines for Design, Construction and Start-up.
• NANO- 201: Measuring and Reporting Vibrations in Advanced Technology Facilities
• NANO-202: Testing Aerosol-Nanomaterial Containment Devices
• NANO-205: Nanotechnology Safety: Application of “Prevention Through Design” Principles to Nanotechnology Facilities

New IEST Recommended Practices

IEST-RP-CC041: Planning for Recovery from Disruption to Cleanrooms and Other Controlled Environments provides guidance for creating a disaster prevention, response, and recovery program for many of the potential direct and indirect risks for failure in the cleanroom.

IEST-RP-CC046: Contamination Control in Controlled Environments provides guidance for controlled environments such as laboratories.

IEST-RP-CC052: Understanding, Identifying and Controlling Electrostatic Charge in Cleanrooms and Other Controlled Environments provides guidance for ESD-sensitive cleanrooms.

Working Groups

Working groups meet twice annually to review and write recommended practices. New working groups that are currently writing recommended practices are:

CC036: Testing Fan Filter Units

CC040: Cleaning Equipment Surfaces in the Cleanroom and Other Controlled Environments

CC042: Sizing and Counting Submicrometer Liquid-Borne Particles using Optical Discrete-Particle Counters

CC044: Vacuum Cleaners and Systems for Cleanrooms and Other Controlled Environments

CC045: Design Considerations for Critical Exhaust Systems

CC047: Cleanroom Lighting

CC051: Airborne-based Particle Measurement Methodologies

CC053: Robotics and Automation in Cleanrooms and Other Controlled Environments

CC054: Evaluating Mops Used in Cleanrooms and Other Controlled Environments

Details about each of the ISO standards and RP’s discussed in this article, along with information on how to participate in Working Groups, can be found in the Standards and RP’s area of the IEST website at www.iest.org.

All documents are available through the IEST bookstore.

 

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