Changes to USP <1788>: Determination of Subvisible Particle Matter from the HIAC and Coulter Counters

A revised version of the USP chapter on Subvisible Particulate Matter USP<1788> became official on May 1, 2021. USP<1788> is meant to expand on the information given in the chapters <787>, <788> and <789> to include for the first time the use of Flow Imaging techniques to provide orthogonal complimentary information to the HIAC high accuracy particle counter used in the compendial Light Obscuration Limit Test. Users are encouraged to develop a particle sizing and counting strategy using an integrated approach of orthogonal, complimentary scientific methods in order to forensically characterize and possibly identify the particle population in injectable dosage form drug products. This paper gives an overview of this amended chapter and the main new recommendations it contains.

Learning Objectives:

  • Learn about the holistic approach to particle sizing and characterization recommended by the new USP<1788> chapter right from drug discovery, through process development and on to final product quality control in the GMP manufacturing environment.
  • Understand the difference between the compendial HIAC pass/fail test and complimentary orthogonal testing methods for particle characterization.
  • Understand why HIAC was chosen in the first instance to supersede the traditional microscopy method and why it remains the preferred instrument for compendial pass/fail Limit testing.

Changes to USP <1788>

usp 1788 changes whitepaper

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