Work Item
ASTM WK91364
New Guide for Development of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment
1. Scope
In this guide, guidance on the development of particle quantification test methods that determine the count and sizes of particulate matter present on the surfaces of single-use bioprocessing equipment (single-use systems, SUS) applied in biopharmaceutical manufacturing processes is described.
In particle quantification test methods, liquid is applied to extract particulate matter from the surfaces of SUS, and the extract is subsequently analyzed with a particle measurement technique to determine particle count and sizes.
Keywords
flow imaging; light obscuration; membrane microscopy; particulate matter; single-use systems
Rationale
In the absence of standards pertaining to the measurement of particulate matter present on the surfaces of SUS, a longstanding practice is to adapt USP <788> (harmonized with EP 2.9.19 and JP 6.07) to SUS.
A complete assessment of the levels of subvisible and visible particulate matter present on the surfaces of SUS requires test methods specifically designed and validated for this purpose. In this guide, guidance is given on the development of “particle quantification test methods,” whereby a SUS is extracted with a test liquid (extraction procedure), the resulting extraction liquid converted into a test sample (test sample preparation procedure), and the test sample analyzed (particle measurement procedure) to determine the particle count and sizes in the test sample.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 06-25-2024
Technical Contact: Klaus Wormuth
Item: 000
Ballot:
Status: