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In the precision-driven world of cleanroom operations, every particle, process, and protocol matters. Whether you're manufacturing life-saving pharmaceuticals or medical devices under strict FDA oversight or assembling microelectronics or aerospace components where the margin for error is microscopic, operational controls are critical – and cleanroom standards play a big role.
For more than two decades, ISO 14644-5: Cleanrooms and Associated Controlled Environments – Part 5: Operations has been the global benchmark for cleanroom practices. But as the cleanroom industry evolved, this standard remained static.
The Long-Awaited Update to Cleanroom Operations Standards
Published in 2004, ISO 14644-5 established international requirements for cleanroom operations across industries. The document covered everything from cleanroom personnel practices and equipment to gowning, cleaning, and materials handling. However, since publication, controlled environments have become more complex and more tightly regulated.
In an attempt to cover 20 years of cleanroom advancement, industry-specific organizations like IEST, ANSI, ASTM, ESD, USP, PDA and ISPE published their own recommended practices to fill in the gaps. The result? A fragmented landscape of cleanroom guidance that left users piecing together an operational strategy from half a dozen different sources.
The newest revision of ISO 14644-5, published in May 2025, changes that. It delivers a modernized, cohesive, and comprehensive operational framework that reflects current technologies, risk profiles, and regulatory expectations – providing the normative framework every cleanroom operator, manager, and compliance officer needs.
A Roadmap for Cleanroom Consumables
One of the most significant changes to the new ISO 14644-5 standards is its alignment and reference to ISO 14644-18: Cleanrooms and Associated Controlled Environments – Part 18: Assessment of Suitability of Consumables, published in 2023. ISO 14644-18 recognizes what cleanroom professionals have long known: gloves, wipers, garments, and other consumables aren't accessories – they’re essential tools and critical materials.
Cleanroom consumables come into direct contact with products, surfaces, and processes. When improperly selected or tested, these materials can become a source of contamination, threatening both compliance and yield.
ISO 14644-18 sets out standardized criteria for evaluating consumables, including:
- Particle counts (airborne and surface)
- Chemical contaminants
- Biocontamination (viable particles, microorganisms or pyrogens)
- Functional performance
- Documentation and traceability
ISO 14644-18 also integrates best practices from the IEST – giving cleanroom managers a clear roadmap for selecting and qualifying consumables.
IEST Recommended Practices: A “How-To” Guide
For the first time, IEST Recommended Practices (RPs), are formally referenced in ISO standards, offering detailed, test-based procedures that support day-to-day cleanroom decisions:
- IEST-RP-CC003 – Cleanroom Garments
Covers garment design, material types, gowning protocols, and lifecycle management using tools like barcoding or radio-frequency identification (RFID). - IEST-RP-CC004 – Wipers
Provides test methods for absorbency, particle release, chemical compatibility, and application-specific selection. - IEST-RP-CC005 – Gloves and Finger Cots
Outlines testing for barrier performance, static dissipation, outgassing, extractables, and microbial risks.
Together with ISO 14644-18, these RPs bring the “how-to” to the updated standards.
A New Era for Cleanroom Operations
The 2025 revision of ISO 14644-5 – together with ISO 14644-18 and IEST’s recommended practices – ushers in a new era of clarity, consistency, and control in cleanroom operations.
With these changes coming soon, now is the time for cleanroom managers to:
- Reevaluate how consumables are selected, qualified and monitored
- Update SOPs and procurement standards to align with the latest ISO guidance
- Utilize IEST RPs for technical direction and best practices
- Revise training programs to reflect new operational requirements
The 2025 ISO 14644-5 revision presents a valuable opportunity for organizations to streamline operations, strengthen compliance, and reduce contamination risk. In the world of cleanrooms – where the margin between meeting standards and falling short is measured in microns – early adoption isn’t just beneficial, it’s essential.
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