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USP 1788 methods review Particle Measuring Systems (PMS) USP 1788 Methods Review

In May 2021 a revision to USP 1788 Methods for Determination of Subvisible Particulate Matter was published, its aim is to aid in clarification and support of the information given in chapters USP 788 Particulate Matter in Injections, USP 789 Particulate Matter in Ophthalmic Solutions, and USP 787 Sub-visible Particulate Matter in Therapeutic Protein Injections. It was previously titled, Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions, and was focused on the validation and instrument requirements of Light Obscuration instruments and microscopic methods variability. However, with the advent of Flow Imaging technologies and new therapeutic protein solutions, the scope was widened. The document’s changes are a valuable orthogonal method that provides complimentary morphology information. Enhanced knowledge of particle type aids in the determination of contamination source and potential correction, if found to be of adverse levels.

Particle Measuring Systems’(PMS) APSS-2000 testing system fully complies with the requirements for use in the testing of solutions in the Normative Chapters:

  • <788> Particulate Matter in Injections,
  • <789> Particulate Matter in Ophthalmic Solutions and
  • <787> Sub-visible Particulate Matter in Therapeutic Protein Injections

And complies with the requirements in the General Chapters:

  • USP 1788 Methods for Determination of Subvisible Particulate Matter
  • USP 1788.1 Light Obscuration Method for the Determination of Subvisible Particulate Matter

Complete the form here to access the full paper and learn about the new USP 1788 requirements

  • Author

    Mark Hallworth

    Global Manager, Life Sciences, Particle Measuring Systems

    Mark Hallworth is the Life Sciences Strategic Senior GMP Scientist. Mark has managed the design, installation and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field, he was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.