Methods and arrangements for inline, online, at-line, and offline process analytical technology testing (pat) boxes, fraction collectors, skids and automated sampling modules

An apparatus for deploying process analytical technology in a pharmaceutical or biopharmaceutical manufacturing process, the apparatus comprising:

• process analytical technology hardware in a housing, wherein the process analytical technology hardware comprises a human machine interface, a controller, and a data acquisition and analysis software layer, and an instrument stack to detect data associated with critical quality attributes in samples of process fluid from the pharmaceutical or biopharmaceutical manufacturing process, wherein the instrument stack comprises one or more process analytical instruments coupled with the data acquisition and analysis software layer provide the data associated with one or more critical quality attributes of the samples;
• and
• a sample injector to transfer the samples from the unit operation or a recirculation line to the process analytical technology hardware for analysis;
• wherein the controller comprises processing circuitry to execute the data acquisition and analysis software layer to analyze the data collected from the one or more process analytical instruments, to execute one or more instrument models to model the one or more process analytical instruments;
• and to execute an analysis model to determine information about the one or more critical quality attributes of the samples,
• wherein the human machine interface communicates the information about the one or more critical quality attributes via a display device;
• wherein the process analytical technology hardware comprises online process analytical technology hardware, at-line process analytical technology hardware, offline process analytical technology hardware, a fraction collector combined with in-line process analytical technology hardware, or a hybrid thereof.