US 12,230,387 B2
Pharmaceutical manufacturing process control, support and analysis
Matthias Friebe, Glattbrugg (CH)
Assigned to Augmenticon AG, Glattbrugg (CH)
Filed by Augmenticon AG, Glattbrugg (CH)
Filed on Dec. 12, 2023, as Appl. No. 18/537,255.
Application 18/537,255 is a continuation of application No. 17/133,167, filed on Dec. 23, 2020, granted, now 11,894,130.
Claims priority of application No. 1919333 (GB), filed on Dec. 26, 2019; application No. 1919334 (GB), filed on Dec. 26, 2019; and application No. 1919335 (GB), filed on Dec. 26, 2019.
Prior Publication US 2024/0120079 A1, Apr. 11, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 40/20 (2018.01); G06F 3/04847 (2022.01); G06F 16/901 (2019.01); G06Q 10/0631 (2023.01); G06Q 10/0639 (2023.01); G06Q 10/10 (2023.01); G06Q 50/04 (2012.01); G06V 20/20 (2022.01); G16H 70/40 (2018.01); H04N 7/14 (2006.01)
CPC G16H 40/20 (2018.01) [G06F 16/9024 (2019.01); G06Q 10/06316 (2013.01); G06Q 10/06395 (2013.01); G06Q 10/103 (2013.01); G06Q 50/04 (2013.01); G06V 20/20 (2022.01); G16H 70/40 (2018.01); H04N 7/147 (2013.01); G06F 3/04847 (2013.01)] 17 Claims
OG exemplary drawing
 
1. A computer apparatus configured to generate a batch record, BR, during manufacture of a batch of pharmaceutical product by populating a master batch record, MBR, the BR-generating computer apparatus comprising:
a process data structure defining a sequence of manufacturing process steps required to be carried out to manufacture a batch, the batch manufacturing process steps involving respective operator actions, wherein the operator actions include performing at least one of a chromatographic and spectroscopic analysis of the batch using a chromatographic or a spectroscopic instrument;
an MBR comprising a plurality of content items and associated fields, wherein the fields are to be populated as an operator progresses through the operator actions, the MBR including a group of fields relating to the analysis;
a mapping data structure that provides links between ones of the operator actions to ones of the content items and associated fields, including for the analysis; and
a control module configured to:
establish a data communication connection to a handheld computer apparatus of an operator responsible for manufacturing the batch;
receive scene image data from the operator's handheld computer apparatus of a graph image captured by the operator's handheld computer apparatus showing results of the analysis;
process the received scene image data to extract a graph and associated graph metadata from the graph image, wherein the graph includes a plurality of peaks;
interpret the peaks of the graph with reference to the graph metadata to obtain peak data;
populate the analysis fields with reference to the mapping data structure with the graph, metadata associated with the graph and peak data associated with the graph;
transmit image data to the operator's handheld computer apparatus to present to the operator the populated analysis fields; and
receive user interface commands from the operator's handheld computer apparatus to accept or reject the populated analysis fields.