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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

    Sr Mark Hallworth

    Gerente Global de Ciências da Vida e Cientista Sênior de GMP, Particle Measuring Systems

    Mark Hallworth é o Cientista Sênior Estratégico de GMP em Ciências da Vida. Mark gerenciou o projeto, instalação e validação de mais de 200 projetos de sistemas de monitoramento ambiental em todo o mundo. Ele projetou vários produtos específicos para monitoramento ambiental farmacêutico, incluindo contadores de partículas para áreas explosivas e corrosivas e software compatível com 21 CFR parte 11 para teste e liberação de lote. Atualmente leciona para o PDA, ISPE e outras sociedades farmacêuticas internacionais sobre monitoramento ambiental e projeto e validação de conformidade com BPF. Mark escreveu mais de 100 artigos técnicos sobre monitoramento ambiental e contribuiu para vários livros específicos para este campo, ele foi premiado com o prêmio IEST James Mildon por « contribuições significativas para o avanço e aumento do conhecimento no campo do controle de contaminação ».