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ASTM E 3060 : 2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
Available format(s)

Hardcopy , PDF

Superseded date

09-11-2023

Language(s)

English

Published date

10-08-2023

CONTAINED IN VOL. 14.05, 2016 Pertains to inherent protein aggregate formation which may change over the product shelf life.

1.1Biotherapeutic drugs and vaccines are susceptible to inherent protein aggregate formation which may change over the product shelf life. Intrinsic particles, including excipients, silicone oil, and other particles from the process, container/closures, equipment or delivery devices, and extrinsic particles which originate from sources outside of the contained process, may also be present. Monitoring and identifying the source of the subvisible particles throughout the product life cycle (from initial characterization and formulation through finished product expiry) can optimize product development, process design, improve process control, improve the manufacturing process, and ensure lot-to-lot consistency.

1.2Understanding the nature of particles and their source is a key to the ability to take actions to adjust the manufacturing process to ensure final product quality. Dynamic imaging microscopy is a useful technique for particle analysis and characterization (proteinaceous and other types) during product development, in-process and commercial release with a sensitive detection and characterization of subvisible particles at 2 and 100 micrometers (although smaller and larger particles may also be reported if data are available). In this technique brightfield illumination is used to capture images either directly in a process stream, or as a continuous sample stream passes through a flow cell positioned in the field of view of an imaging system. An algorithm performs a particle detection routine. This process is a key step during dynamic imaging. The digital particle images in the sample are processed by image morphology analysis software that quantifies the particles in size, count, and other morphological parameters. Dynamic imaging particle analyzers can produce direct determinations of the particle count per unit volume (that is, particle concentration), as a function of particle size by dividing the particle count by the volume of imaged fluid (see Appendix X1).

1.3This guide will describe best practices and considerations in applying dynamic imaging to identification of potential sources and causes of particles during biomanufacturing. These results can be used to monitor these particles and where possible, to adjust the manufacturing process to avoid their formation. This guide will also address the fundamental principles of dynamic imaging analysis including image analysis methods, sample preparation, instrument calibration and verification and data reporting.

1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5This 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 and health practices and determine the applicability of regulatory limitations prior to use.

Committee
E 55
DocumentType
Guide
Pages
14
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM E 2589 : 2011 Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ISO 2859:1974 Sampling procedures and tables for inspection by attributes
ASTM E 2589 : 2023 : REV A Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASME BPE : 2016 BIOPROCESSING EQUIPMENT
BS 6001-1(1999) : 1999 SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION
ASTM E 2589 : 2008 Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASTM E 2589 : 2009 : REV A Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASTM E 2589 : 2011 TERMINOLOGY RELATING TO NONSIEVING METHODS OF POWDER CHARACTERIZATION
ASTM E 2589 : 2008 : REV A Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASTM E 2589 : 2011 : R2016 Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASTM E 2589 : 2022 Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASTM E 2589 : 2008 : REV B Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ASTM E 2589 : 2023 Standard Terminology Relating to Nonsieving Methods of Powder Characterization
ISO 9276-6:2008 Representation of results of particle size analysis — Part 6: Descriptive and quantitative representation of particle shape and morphology

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