New Edition of ISO 14644-15 published
Recommendation

13-15 October 2026
GMP Compliance and Technology for the Manufacture of Oral Solid Dosage Forms
With the publication of ISO 14644-15:2026, the second edition of the standard for the assessment of chemical emissions from materials and equipment in cleanrooms is now available. The standard replaces the previous ISO 14644-15:2017.
The standard describes procedures for assessing whether system components, materials or equipment can affect cleanroom quality through airborne chemical contamination. The focus is particularly on emission measurements and the assessment of suitability for use in controlled environments.
The standard excludes application in occupational health and safety; compatibility with cleaning agents; cleanability; biocontamination; specific requirements for equipment and materials for processes and products; and design details of installations.
ISO 14644-15 is closely related to the ISO 14644 series on chemical air purity, in particular ISO 14644-8. Among other things, it covers test set-ups, operating conditions, measurement methods for airborne chemical concentrations, emission rates and documentation requirements.
The new edition has primarily been editorially revised and clarified. No fundamental changes have been made to test concepts or evaluation principles.
The practical relevance of the standard has so far been primarily in sectors with high requirements for chemical air purity, such as the semiconductor, microelectronics or optical industries. For the pharmaceutical industry, ISO 14644-15 is of a more supplementary nature, as the GMP sector primarily focuses on particulate and microbiological contamination. However, the standard may become relevant for particularly sensitive processes and material evaluations.
The standard is available from DIN Media.
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