Monitoring Vial Conditions During a Lyophilization Process

    公开(公告)号:US20230194166A1

    公开(公告)日:2023-06-22

    申请号:US17924925

    申请日:2021-05-11

    Applicant: AMGEN INC.

    CPC classification number: F26B5/06 F26B21/10

    Abstract: A method of facilitating real-time monitoring of conditions within a vial during a lyophilization process occurring within a lyophilization chamber includes, for each of a plurality of time intervals during the lyophilization process, determining current values of temperature and pressure within the lyophilization chamber and, after each time interval, determining current values of one or more conditions within the vial. Determining the current values of the condition(s) within the vial includes applying those current values as inputs to a heat and mass transfer balance model and solving for a current value of a temperature within the vial (and possibly water removed from or remaining within the product). The method also includes causing a display device to display the current value(s) of the condition(s) within the vial to a user, and/or controlling the temperature and/or pressure within the lyophilization chamber based on the current value(s) of the condition(s) within the vial.

    INTELLIGENT MITIGATION OR PREVENTION OF EQUIPMENT PERFORMANCE DEFICIENCIES

    公开(公告)号:US20240045414A1

    公开(公告)日:2024-02-08

    申请号:US18269015

    申请日:2022-01-03

    Applicant: AMGEN INC.

    CPC classification number: G05B23/0254 G05B23/0221 G05B23/0275

    Abstract: A method of diagnosing or predicting performance of equipment includes determining values of one or more parameters associated with the equipment by monitoring the one or more parameters over a time period in which the equipment is in use. The method also includes determining, by processing the values of the one or more parameters using a classification model, a performance classification of the equipment, mapping the performance classification to a mitigating or preventative action, and generating an output indicative of the mitigating or preventative action.

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