ASTM WK34349

    New Guide for THE APPLICATION OF CONTINUOUS PROCESSING IN THE PHARMACEUTICAL INDUSTRY

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    Developed by Subcommittee: E55.01 | Committee E55 | Contact Staff Manager



    WK34349

    1. Scope

    In terms of this document, continuous processes are defined as meeting one or more of the following criteria: Materials are fed into the system at the same time as product is removed from the system. The process materials condition is a function of its position within the process as it 81 flows from inlet to outlet. The quantity of product produced is a function of the duration for which the process is operated, the throughput rate of the process. A Continuous process may be a single unit operation or multiple continuous unit operations (line) linked together 89 (Appendix I); include transformations of quantities of material which may be viewed as discrete events, however when viewed from the scale of the overall process these form an effective continuum. E.g. the drying of a single droplet in a spray dryer. The principles laid out in this document are applicable to both Drug Substance (DS) and Drug Product (DP) processes. They apply during development of a new process or the improvement and / or redesign of an existing one.


    Keywords

    PHARMACEUTICAl, continuous process, drug substance, drug product processes

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    08-04-2011

    Technical Contact:
    Trevor Page

    Item:
    001

    Ballot:
    E55 (14-06)

    Status:
    In Balloting