The IEST holds two conferences each year. ESTECH, the annual technical meeting of the Institute of Environmental Sciences and Technology (IEST), was held April 27-30 in Danvers, Mass. The IEST Fall Conference will be held Nov. 9-12 at the Crowne Plaza O’Hare. The cleanroom and controlled environment industries rely on two main sources for standards and best practices in cleanroom and contamination control management: IEST and the International Organization for Standardization (ISO).
Since launching its program to develop global cleanroom standards in 1990, ISO has published 10 ISO 14644 standards under the auspices of Technical Committee (ISO/TC) 209, Cleanrooms and associated controlled environments. The voting members of ISO/TC 209 represent 22 nations. The ISO 14644 cleanroom standards established airborne particulate cleanliness classes for particle sizes ranging from 0.1 μm to 5 μm. Nine of these international standards have also been approved by the American National Standards Institute (ANSI) as American national standards. IEST is Secretariat of ISO/TC 209 and Administrator of the ANSI-accredited US Technical Advisory Group (TAG) to ISO/TC 209.
IEST also develops recommended practices (RPs) for the nanotechnology; contamination control; design, test, and evaluation; and product reliability industries. For more than 60 years, this society has tapped the voluntary commitment of industry professionals to develop these documents based on their industries’ best practices.
Together, these non-profit organizations contribute a vast amount of knowledge and resources to the cleanroom and controlled environments industries. This article will provide an overview and summarize the key points of the full array of contamination control guidance documents produced by IEST and ISO and presented at ESTECH 2015.
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: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (2000). These standards, together considered the cornerstone of the ISO cleanroom series, are being updated, and revisions were issued in Sept. 2014 as Draft International Standards (DIS). The final draft standard will be released in mid-2015. One of the major changes concerns a new principle for selection of cleanroom sample locations. Currently, both the original standards and the DIS versions may be used as trade reference per agreement between customers and suppliers.
Several IEST RPs enable end users to meet the requirements of ISO 14644-1 and -2, including:
• IEST-RP-CC001: HEPA and ULPA Filters — For use as a reference prior to selecting air filters for the cleanroom.
• IEST-RP-CC002: Unidirectional-Flow, Clean-Air Devices — Reviews products and systems available 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 classifications.
• IEST-RP-CC007: Testing ULPA Filters — For use to evaluate ULPA filters used 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 filtration properties, and includes a table on filter-testing frequency.
The most current revisions to filtration recommended practices (CC001, CC007, CC021, and CC034) are scheduled to be published in 2015.
Additionally, IEST publishes four technical guides to assist cleanroom operators 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-G-CC1004: Sequential-Sampling Plan for Use in Classification of the Particulate Cleanliness of Air in Cleanrooms and Clean Zones
ISO/TC 209 published two biocontamination control standards in 2000: ISO 14698-1 General principles and methods and ISO 14698-2 Evaluation and interpretation of biocontamination data. Associated RPs that assist cleanroom operators in achieving the principles in these ISO standards are IEST-RP-CC013: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Cleanrooms and other Controlled Environments, and IEST-RPCC023: Microorganisms in Cleanrooms.
ISO 14644-3: Test methods specifies metrology and test methods for characterizing the performance of cleanrooms and clean zones. Relatedly, IEST-RP-CC014: Calibration and Characterization of Optical Airborne Particle Counters and IEST-RP-CC034: HEPA and ULPA Filter Leak Tests provide test methods for compliance with ISO 14644-3.
Cleanroom design and construction 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. IESTRP-CC024: Measuring and Reporting Vibration in Microelectronics Facilities provides guidance regarding the special vibration considerations for equipment in the cleanroom. IEST-RP-CC022, Electrostatic Charge in Cleanrooms and Other Controlled Environments addresses design aspects that enable control of static electricity in cleanrooms.
Cleanroom design and construction
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. IESTRP-CC024: Measuring and Reporting Vibration in Microelectronics Facilities provides guidance regarding the special vibration considerations for equipment in the cleanroom. IEST-RP-CC022, Electrostatic Charge in Cleanrooms and Other Controlled Environments addresses design aspects that enable control of static electricity in cleanrooms.
IEST RPs that support the basic requirements outlined in ISO 14644-5: Operations include:
• IEST-RP-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments — Use to select garments to protect both product and personnel from contaminants.
• IEST-RP-CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments — Use to evaluate wipers used to clean surfaces of the product and the cleanroom. Wipers should be selected based on their intended usage.
• IEST-RP-CC005: Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments — Use 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 Housekeeping: 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 Controlled Environments — Reviews behavior requirements for personnel working inside the cleanroom and includes gowning requirements.
• IEST-RP-CC032: Flexible Packaging Materials for Use in Cleanrooms and Other Controlled Environments — Provides guidance for the selection of packaging to protect product integrity.
Minienvironments and enclosures
ISO 14644-7: Separative devices addresses enclosures such as barrier isolator systems, clean air hoods, gloveboxes, and minienvironments. IESTRP-CC028: Minienvironments provides guidance specifically for minienvironments in cleanrooms.
The 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 air cleanliness by chemical concentration (ACC) addresses airborne concentrations of specific chemical substances and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.
The recommended practice IEST-RPCC035: Design Considerations for Airborne Molecular Contamination 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 selecting of compatible materials.
ISO 14644-9: Classification of surface cleanliness by 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 cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms, and particles).
IEST-STD-CC1246E: Product Cleanliness Levels — Applications, Requirements, and Determination, a standard for testing of surfaces for contaminants, provides guidance for the selection of the test methods to demonstrate the cleanliness
level required. IEST also has an RP (IESTRP-CC043: Surface Molecular Contamination) under development on this topic that will describe the types of surface molecular contamination (SMC) that may affect critical surfaces and processes, as well as the sources of SMC and measurement and control methods.
ISO/TC 209 also established a nanotechnology working group (WG) to develop contamination control standards for industries involved with nanoscale materials and devices. This WG is convened by the US under the leadership of IEST. The first document will be written to help nanotechnology professionals apply the existing series of ISO/TC 209 documents. Future standards are proposed to include classification of air cleanliness and metrology; design, construction, and start-up; operations; and nanobiotechnology. Another ISO technical committee, ISO/TC 229 Nanotechnologies, is addressing all aspects of this emerging discipline. IEST represents the environmental sciences as a voting member of the ANSI-accredited US TAG to ISO/TC 229.
IEST WGs are developing a series of RPs addressing nanotechnology topics. IEST-RPNANO200: Planning of Nanoscale Science and Technology Facilities: Guidelines for Design, Construction, and Start-up, was published in 2013. Also under development is IEST-RPNANO205: Nanotechnology Safety: Applying Prevention through Design Principles to Nanotechnology Facilities. At ESTECH 2015, two new working groups are being formed: Vibration and Acoustics in Nanotechnology, and Testing Aerosol-Nanomaterial Containment Devices.
Also on the docket
IEST recently published IEST-RP-CC046: Controlled Environments (Aerospace, Noncleanroom) and IEST-RP-CC042: Sizing and Counting of Submicrometer Liquid-Borne Particles Using Optical Discrete-Particle Counters.
Several RPs are under development and revision. Interested professionals are invited to participate in the working groups at ESTECH and at the Fall Conference. Titles under development or revision include:
• Vibration and Acoustics in Nanotechnology
• Testing Aerosol-Nanomaterial Containment Devices
• CC002: Unidirectional-Flow, Clean-Air Devices
• CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments
• CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments
• CC006: Testing Cleanrooms
• CC012: Considerations in Cleanroom Design
• CC019: Qualifications for Organizations Engaged in the Testing and Certification of Cleanrooms and Clean-Air Devices
• CC020: Substrates and Forms for Documentation in Cleanrooms
• CC021: Testing HEPA and ULPA Filter Media
• CC023: Microorganisms in Cleanrooms
• CC025: Evaluation of Swabs Used in Cleanrooms
• CC034: HEPA and ULPA Filter Leak Tests
• CC041: Recovery from Disruption to Cleanrooms and Other Controlled Environments
• CC044: Vacuum Cleaners and Systems for Cleanrooms and Other Controlled Environments
• CC046: Contamination Control in Controlled Environments
• CC047: Cleanroom Lighting
• CC048: Guidance of Design, Performance, and Operations for Controlled Environments per USP 797
• CC205: Nanotechnology Safety: Applying Prevention through Design Principles to Nanotechnology Facilities
• CC902: MIL-HDBK-406: Contamination Control Technology: Cleaning Materials for Precision Pre-Cleaning and Use in Cleanrooms and Clean Work Stations; MIL-HDBK-407: Contamination Control Technology: Precision Cleaning Methods and Procedures
Details about each of the standards and RPs discussed in this article, along with information on how to participate in working groups, can be found in the Standards RPs area of the IEST website at www.iest.org. The documents, including both the original and revised versions of ISO 14644 parts 1 and 2, are available through the IEST Bookstore.
Standards Training — Continuing Education Program
Contamination control courses offered at ESTECH will explain practical applications of various standards and RPs. One course will focus on using documents to comply with USP Chapter 797, Pharmaceutical Compounding — Sterile Preparations:
Cleanroom Operations for USP 797 will explain what is required to reduce the risk of microbial contamination, with reference to IEST-RP-CC018.4: Cleanroom Housekeeping: Operating and Monitoring Procedures and IEST-RP-CC026: Cleanroom Operations.
The popular ISO Certificate Series will provide insights on the ISO cleanroom standards and pending revisions. These two courses in the series may also be taken individually: Evolution and Revolution in the Cleanroom: New ISO 14644-1 and -2 Standards discusses the significant changes in the newly revised Draft International Standards, how they impact your cleanroom operations, and the rationale of the documents. Application of ISO 14644-3 discusses the practical application of the series that a certification contractor would use to certify a clean space, including an open discussion on how best to implement these standards.
A new Cleanroom Basics course is being offered as an overview of all the IEST recommended practices and ISO 14644 standards applicable to the design, construction, and operation of a controlled environment.
Those interested in attending all of these courses can register for the ESTECH Education Passport and take advantage of savings on a full four days of training. Additionally, IEST conducts on-site training at IEST headquarters in Arlington Heights, Ill., and on-site training at a company’s designated site. All training is performed by senior IEST faculty members who are experts in their fields.
Jan Eudy is a Cleanroom/Contamination Control Consultant as well as a Fellow and Past President, Institute of Environmental Sciences and Technology. She is located in Carolina Beach, N.C. and can be reached at firstname.lastname@example.org.
This article appeared in the May/June 2015 issue of Controlled Environments.