Table of Contents
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
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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- What’s the Correct Way to Wipedown a Surface? What’s the Advantage of Microfiber Wipes?What is the proper technique for wipedown and sanitation of surfaces? Why is a microfiber wipe most effective for viruses and infection control?
Shop Wipe Supplies by ISO Class
Wipes
Find dry, pre-saturated, and sterile wipes to meet strict demands of controlled cleanroom areas.
Mops
Cleanroom features include lint free fibers, multi-bucket antimicrobial features and no drip systems.
Disinfectants
EPA Registered disinfectants, effective against most pathogens. Fragrance & dye free.
Manufacturing Related
How Do I Properly Wipe Down Surfaces in Cleanrooms and Labs?
What are the proper steps for wiping surfaces, biological isolators, and laminar flow cabinets, and excess hazardous drugs?
Cleanroom Wipes for Pharmaceuticals: Pyrogen Testing Methods
Cleanroom wipes and gloves undergo LAL and Agar Overlay Analysis when testing for pyrogen and endotoxin levels. This post details the methodology, historical relevance, and explores cleanroom solutions for pyrogen-free and low-endotoxin gloves and garments.
Particulate and Molecular Contamination Tests for Cleanroom Wipes and Fibers
The majority of wiper contamination tests probe for particles, fibers, ions, nonvolatile residue, and bio-contaminants. Cleanroom wipe test methods detail and measure the extraction and enumeration particles, fibers, and other contamination released from wipers (or other materials), usually in a wetted state, under conditions of moderate mechanical stress.
Cleanroom Wipe Contamination Profiles for Medical Device Wipedown & Electronics
The ideal cleanroom wipe must meet industrial and regulatory standards concerning chemical, physical, and biological compatibility. Wipe fabrics undergo a strict examination to simulate manufacturing outcomes in the real world.
Stretch and strength, chemical compatibility, task efficiency, sorbency, shed, retention, and biological harmony have unique consequences in both high-tech cleanrooms and general manufacturing floors.
Cleanroom Sticky Rollers and Foam Mops for Walls Ceilings, and Floors
Cleanroom tacky rollers and sticky foam rollers remove particulate from flat and slightly textured surfaces within a cleanroom. Extendable mop handles with adhesive rollers on the ends allow easy access to cleanroom, floors, ceilings, and walls.
Polycellulose & Polyester Cleanroom Wipe Supplies
Here’s the guide to buying cleanroom wipes that stay on-budget. Differing package sizes, bulk counts, edge types, material options, cloth size, weights, ISO class, substrates, ionic levels…comparing cleanroom wipes is mind numbing. 50% of leading cleanroom wipe advertisers don’t even offer prices online!
New: Texwipe Cleanroom Products
Texwipe offers a variety of dry, pre-saturated, and sterile wipes to meet the strict demands of controlled environments. Texwipe swabs are manufactured to exacting and consistent tolerances with lot coded for traceability and quality control.
Cleanroom Wipe Use, Protocol, and ISO Class Standards
Cleanroom wipes differ by application, cleanliness, materials, and essential properties. This post addresses cleanroom wipe ISO classes and properties. What’s the right wipe for ISO class 5, ISO 6, ISO 7, or ISO 8??
The Seven Deadly Sins of Cleanroom Wiping (and How to Avoid Them!)
1. Ignoring the Need to Wipe on a Regular Basis To assure quality is maintained in all cleanroom and restricted areas, housekeeping maintenance must be
Air Showers: Increasing Productivity & Reducing Costs of Cleanroom Operations
Article reprinted from Clean Air Products, manufacturers of air showers, cleanrooms, and cleanroom accessories. A cleanroom provides a controlled environment in which companies can produce
