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Setting Up Selection Criteria for Re-usable and Single-use Cleanroom Consumables
Debunking bad science to simplify product selection.
A Class 10 cleanroom garment or a Class 100 wiper or glove does not exist. Manufacturers asserting a product is certified to a broad cleanroom standard is an overgeneralization that was the result of a marketing fad in the 1990s.
This technical paper explains how controlled environments should develop criteria for critical reusable and single-use materials in line with IEST Recommended Practices.
At the time, manufacturers attempted to tie the Federal Standard 209E for air cleanliness classifications (e.g. Class 10, 100, 1000) to cleanroom materials, making comparisons that did not necessarily exist.
Federal Standard 209E was replaced by ISO 14644-1 and -2 air cleanliness classifications (e.g. ISO 4,5,6) in 1999. Additionally, characterizing a cleanroom wiper, garment or mop as non-linting or non-shedding is misleading.
All consumables brought into the cleanroom, whether reusable or single-use, will shed particles at some level of detection. Do not be confused or misled by vendors that perpetuate the bad science of marketing an environmental air quality cleanliness standard (Federal Standard 209E or ISO 14644-1 and -2) for consumables used in that environment.
How should controlled environments develop criteria for critical reusable and single-use materials?
Approximately 20% of the controlled environment market provides laundering services for reusable cleanroom garments, monitoring, certification, and cleaning services. The balance of vendors in the cleanroom market supplies consumables: gloves, wipes, mops, tacky mats, disposable apparel, paper, swabs, etc.
Consumables worn and brought into the cleanroom protect the product, process, and integrity of the cleanroom to varying degrees. As NEBB studies illustrate, 70% of the contaminants in your cleanroom are operator-generated.
Therefore, the vendors supplying the consumables are critical to the success of the cleanroom integrity, and selecting the most effective garments, gloves and wipes should be more than a procurement pricing and availability exercise.
Vendor selection for cleanroom consumables used in controlled environments should be based on criteria found in IEST Recommended Practices and ISO 14644 series of international cleanroom standards.
Purchasing, production, and quality departments must collaborate to determine the best solution for their product, process, and people. The final specification for consumables worn and brought into cleanrooms should be based on test data released by the manufacturer or an independent, third-party lab.
IEST Recommended Practices
Several IEST RPs address the test parameters and recommend specifications. IEST recommends testing methods that are generally accepted, published, and repeatable at third-party labs.
An operation’s internal testing methods should correlate with the published manufacturer specifications. If the testing methods are not consistent, the user should perform testing on each production lot to ensure the incoming material is compliant with their internal specification.
- 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 the 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.
Qualifying A Secondary Source For Cleanroom Consumables
Before the COVID-19 pandemic, most cleanroom operations sourced critical materials used in cleanroom production from a sole source vendor that provided just-in-time delivery of the materials.
During the past three years, the supply chain for these materials has been severely disrupted. To make supply chains more resilient and redundant, leading cleanroom operations are now qualifying and actively sourcing from primary and secondary manufacturers for critical materials. A redundant source is now widely considered a best practice in the cleanroom consumable qualification process.
When selecting multiple vendors, it is imperative to compare each product by its tested characteristics and suitability for use in that specific application. Challenge any new material vendor to demonstrate the product equivalency of its recommendation to your incumbent product before starting the new product qualification process.
Authored by Jan Eudy for Valutek.
Jan is an independent Cleanroom and Contamination Control consultant as well as a Fellow, Past President, and Senior Faculty Instructor of the Institute of Environmental Science and Technology.