ISO 14644-15:2017

Overview

ISO 14644-15:2017 - "Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration" - provides requirements and guidelines for evaluating the chemical airborne cleanliness of equipment and materials intended for use in cleanrooms and controlled zones. It links to the ACC (air cleanliness by chemical concentration) approach in ISO 14644‑8 and focuses on measuring emissions, calculating specific emission rates, and assessing suitability for an existing or planned cleanroom environment.

The standard excludes health & safety, cleaning-agent compatibility, cleanability, biocontamination, product- or process‑specific requirements, and equipment design details.

Key Topics

• Test setup and configurations: procedures for closed design, open design, and special applications to capture realistic emission behavior.
• Representative mode and samples: guidance on selecting representative material samples and representative operating modes for equipment.
• Visual inspection: checks for visible contamination sources and suitability of the equipment/material before testing.
• Measurement and test description: methods to sample and quantify airborne chemical species emitted from materials/equipment.
• Calculations:
  • Measured concentrations and data handling.
  • Specific emission rate calculations for both closed and open designs.
  • Assessment calculations to determine impact on a cleanroom or controlled zone (how emissions translate to ACC class impact).
• Assessment criteria: approach to determine whether equipment/materials are suitable for use in a given ACC class.
• Documentation: required test reports, input data, and records to support suitability decisions.
• Annex examples: worked examples of suitability assessments (Annex A–C) for equipment, wall/floor materials, and combined systems.

Applications

ISO 14644-15 is used to:

• Evaluate whether equipment or building materials will meet chemical cleanliness requirements in controlled environments.
• Quantify emission rates to predict impact on target ACC classes.
• Support procurement, installation, and qualification decisions for cleanrooms.
• Provide documented evidence for risk assessment and validation activities.

Typical sectors: pharmaceuticals, medical devices, microelectronics, aerospace, optics, food processing, and life sciences - essentially any industry where airborne chemical contamination can affect product quality or process integrity.

Who should use this standard

• Cleanroom designers and facility engineers
• Validation/QA specialists and contamination-control engineers
• Equipment and material manufacturers/suppliers
• Regulatory and compliance teams assessing environmental suitability

Related standards

• ISO 14644 series (general cleanroom standards)
• ISO 14644-8:2013 - Classification of air cleanliness by chemical concentration (ACC), which ISO 14644-15 references for ACC classes and criteria.

Keywords: ISO 14644-15, cleanrooms, airborne chemical concentration, ACC, chemical airborne cleanliness, emission rate, cleanroom suitability, ISO 14644 series.