Cleanroom Wipe Testing Standards for ASTM, IEST & ISO Organizations
What Is A Cleanroom Standard?
Standards organizations define high-detail techniques and scientifically backed approaches towards “standardized” measurements and tests. The most common standards organizations for cleanroom manufacturing include ASTM, IEST, and ISO.
Cleanroom Wipe Evaluation Quick Links
— Particulate | Fiber Testing Methods
— Ionic Contamination, Trace Metals & Heavy Metal Contamination
— Nonvolatile Residue – NVR – in Cleanrooms
— Microbiological & Pyrogen Testing
— Profiles for Medical Device Wipedown & Electronics
— Wipe Testing Standards for ASTM, IEST & ISO Organizations
ASTM Cleanroom Wipe Tests & Standards
ASTM (American Standards for Testing and Measurement) is an organization representing the collective expertise and judgment of stakeholders from industry, government, academia, trade groups, consumers, and more. ASTM International standards are known for establishing high quality best practices, measurement methods, and technique validation for repeatable manufacturing outcomes.
“2,000 subcommittees) meet face-to-face and virtually, using tools like electronic balloting and online collaboration areas, to develop standards. ASTM International publishes those standards shortly thereafter.”
ASTM Tests for Cleanroom Wiper Materials Examples
ASTM E 2090, Standard Test Method for Size Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy
ASTM E 1560, Standard Test Method for Gravimetric Determination of Nonvolatile Residue from Cleanroom Wipers
ASTM F 50, Standard Practice for Continuous Sizing and Counting of Airborne Particles in Dust Controlled Areas and Clean Rooms Using Instruments Capable of Detecting Single Sub Micrometre and Larger Particles
ASTM E 2090, Standard Test Method for Size Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy
EN 1276 for bacterial efficacy,
EN1650 for fungal efficacy.
EN 13704 for sporicidal efficacy.
IEST Cleanroom Wipe Test Methods & Standards
IEST (Institute for Environmental Sciences and Technology) is a standards organization that outlines industrial benchmarks for assessing cleanroom wiper performance, test methods, and validation benchmarks.
IEST-RP-CC016, The Rate of Deposition of Nonvolatile Residue in Cleanrooms
IEST-STD-CC1246, Product Cleanliness Levels and Contamination Control Program
IEST-RP-CC003, Garment System Considerations for Cleanrooms and Other Controlled Environments
IEST-RP-CC004: Evaluating Wiping Materials Used In Cleanrooms And Other Controlled Environments is one of the most common cleanroom methodologies for task wiper contamination testing and benchmarks.
Read: Complete Guide to IEST Test Methods for Cleanroom Wipes and Fabrics
ISO Class Cleanroom Wipe Requirements
Establishing proper ISO rated products is important for a minimal cleanroom product assessment, but not sufficient. ISO standards regard particle counts, however, device sensitivity may require a much cleaner, softer, or absorbent wipe than the respective ISO class particle counts.
ISO Standards for Cleanroom Wipes
“Methods for selecting, applying and controlling suitable procedures for cleaning and disinfection are indicated in ISO 14698-1 and ISO 14698-3, and other relevant parts of this International Standard.”
ISO 9073-10:2005-03 Textiles – Test Methods for Nonwovens – Part 10: Lint and other particle generation in the dry state.
ISO 14698-1 and ISO 14698-3 – Standards which address suitable procedures for cleaning and disinfection
ISO 10993 covers the biological evaluation of medical devices for toxicity. Inherently, understanding the potential toxicity of a product or device must also consider potential contamination sources such as wipes, garments, chemicals, operators, and manufacturing processes.
Cleanroom Wipe Applications and ISO Classes
A cleanroom often requires cascading classifications of ISO classes. For example, a pharmaceutical compounding cleanroom maintains both critical and non-critical areas which range between non-classified S-CSA and less critical ISO 7 or ISO 8 buffer and gowning rooms to ISO 3 – 5 primary production areas.
The most basic cleanroom wipe selection criteria must consider baseline particulate shed thresholds for the end-user environment. Like any cleanroom rated product, cleanroom wipe manufacturers qualify ISO wipers between ISO Class 1 – ISO Class 9 as specified in step with cleanroom classifications of the International Standards Organization (ISO). The majority of cleanroom classifications fall between ISO 5 – ISO 8.
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