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  • ASTM
    E3495-25 Standard Classification for Reporting Particle Contamination and Insoluble Droplets in Water and other Pharmaceutical Fluids When Analyzed by Direct Imaging Analyzers
    Edition: 2025
    $144.00
    Unlimited Users per year

Description of ASTM-E3495 2025

ASTM E3495-25

Active Standard: Standard Classification for Reporting Particle Contamination and Insoluble Droplets in Water and other Pharmaceutical Fluids When Analyzed by Direct Imaging Analyzers




ASTM E3495

Scope

1.1 This classification identifies a concise code which can be used by direct imaging analyzers (DIA) for reporting counts of particle and insoluble droplet contamination in pharmaceutical and biotech fluids. The coding system includes the reporting of droplet content and particle counts in the ≥1 µm range. This classification is comparable to ISO 4406, but its requirements are not inferred.

1.2 It is valid for DIA calibrated and verified per the requirements of this document, and applies to reporting of contamination in cleaning fluids as well as process fluids.

1.3 The values stated in SI units are to be regarded as standard. No other units of measure are included in this standard.

1.4 Due to the variation of method and instrument types and resolutions, the reporting of results will include the ASTM standard used to conduct the analysis.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords

droplet; imaging; particle count;


ICS Code

ICS Number Code n/a


DOI: 10.1520/E3495-25



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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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