Pharmaceutical manufacturing process control, support and analysis

1 . A computer apparatus configured to provide a process control function during manufacture of a batch of pharmaceutical product by an operator to check whether a piece of equipment has been set up correctly to carry out a manufacturing process step, the process controlling computer apparatus being configured to:

establish a data communication connection to a portable computer apparatus of an operator;

receive scene image data from the operator's portable computer apparatus of an image captured by the operator's portable computer apparatus;

process the received scene image data to identify an image of the piece of equipment and attempt to segment a pre-defined plurality of objects from the equipment image, and make a determination of its correct or incorrect set up by checking each segmented object; and

transmit data to the operator's portable computer apparatus conveying an indication of the correct or incorrect set up, wherein the transmitted data includes image data for the operator's portable computer apparatus to augment the scene by providing an indication of at least incorrectly set up segmented objects, and wherein the transmitted data includes an indication of any of the pre-defined objects that the process controlling computer apparatus was unable to segment from the equipment image.

2 . The computer apparatus of claim 1 , wherein the image data provides an indication also of correctly set up objects.

3 . The computer apparatus of claim 1 ,

wherein the process controlling computer apparatus is further configured to generate a batch record, BR, during manufacture of the batch of pharmaceutical product by populating a master batch record MBR, the process controlling computer apparatus further 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, and the manufacturing process steps including said one relating to the equipment set up;

a mapping data structure that provides links between ones of the operator actions to ones of the content items and associated fields;

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 process controlling computer apparatus being configured to:

transmit image data to the operator's portable computer apparatus, the image data presenting ones of the content items and associated fields to the operator in a way that follows the operator's progression through the operator actions as determined with reference to the mapping data structure and that is responsive to the operator populating the MBR fields; and

populate fields of the MBR, as presented to the operator in the image data, responsive to receipt of the user interface commands.

4 . The computer apparatus of claim 1 , wherein the operator's portable computer apparatus is an augmented reality headset.

5 . The computer apparatus of claim 1 , wherein the operator's portable computer apparatus is selected from the group consisting of: a tablet computer, a mobile phone and a laptop computer.

6 . A computer apparatus configured to provide a process control function during manufacture of a batch of pharmaceutical product by an operator to check whether a piece of equipment has been set up correctly to carry out a manufacturing process step, wherein the equipment set up involves arrangement of vials in set locations in relation to the equipment, and the process controlling computer apparatus is configured to:

establish a data communication connection to a portable computer apparatus of an operator;

receive scene image data from the operator's portable computer apparatus of an image of the equipment captured by the operator's portable computer apparatus;

process the received scene image data to identify any vials found in the scene and to identify whether they are at their set locations, wherein making the determination of correct or incorrect equipment set up takes account of whether the vials are at their set locations; and

transmit data to the operator's portable computer apparatus conveying an indication of the correct or incorrect set up.

7 . The computer apparatus of claim 6 , wherein the equipment set up involves arrangement of vials in relation to the equipment, and the process controlling computer apparatus is further configured to:

process the received scene image data to perform vial identification on any vials found in the scene image data by reading a machine-readable code attached to any such vial; and in response thereto

transmit data to the operator's portable computer apparatus providing feedback information extracted through each code.

8 . The computer apparatus of claim 6 ,

wherein the process controlling computer apparatus is further configured to generate a batch record, BR, during manufacture of the batch of pharmaceutical product by populating a master batch record MBR, the process controlling computer apparatus further 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, and the manufacturing process steps including said one relating to the equipment set up;

a mapping data structure that provides links between ones of the operator actions to ones of the content items and associated fields;

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 process controlling computer apparatus being configured to:

transmit image data to the operator's portable computer apparatus, the image data presenting ones of the content items and associated fields to the operator in a way that follows the operator's progression through the operator actions as determined with reference to the mapping data structure and that is responsive to the operator populating the MBR fields; and

populate fields of the MBR, as presented to the operator in the image data, responsive to receipt of the user interface commands.

9 . The computer apparatus of claim 6 , wherein the operator's portable computer apparatus is an augmented reality headset.

10 . The computer apparatus of claim 6 , wherein the operator's portable computer apparatus is selected from the group consisting of: a tablet computer, a mobile phone and a laptop computer.

11 . A computer apparatus configured to provide a process control function during manufacture of a batch of pharmaceutical product by an operator to check whether a piece of equipment has been set up correctly to carry out a manufacturing process step, wherein the equipment set up involves removal of an item from the equipment, the process controlling computer apparatus being configured to;

establish a data communication connection to a portable computer apparatus of an operator;

receive scene image data from the operator's portable computer apparatus of an image captured by the operator's portable computer apparatus;

process the received scene image data by segmenting the image to identify whether the item has been removed or is still present; and

transmit data to the operator's portable computer apparatus conveying an indication of a need for item removal.

12 . The computer apparatus of claim 11 , wherein the transmitted data includes image data for the operator's portable computer apparatus to augment the scene by providing an indication of an item that is still in place.

13 . The computer apparatus of claim 11 ,

wherein the process controlling computer apparatus is further configured to generate a batch record, BR, during manufacture of the batch of pharmaceutical product by populating a master batch record MBR, the process controlling computer apparatus further 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, and the manufacturing process steps including said one relating to the equipment set up;

a mapping data structure that provides links between ones of the operator actions to ones of the content items and associated fields;

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 process controlling computer apparatus being configured to:

transmit image data to the operator's portable computer apparatus, the image data presenting ones of the content items and associated fields to the operator in a way that follows the operator's progression through the operator actions as determined with reference to the mapping data structure and that is responsive to the operator populating the MBR fields; and

populate fields of the MBR, as presented to the operator in the image data, responsive to receipt of the user interface commands.

14 . The computer apparatus of claim 11 , wherein the operator's portable computer apparatus is an augmented reality headset.

15 . The computer apparatus of claim 11 , wherein the operator's portable computer apparatus is selected from the group consisting of: a tablet computer, a mobile phone and a laptop computer.

16 . A computer apparatus configured to provide a process control function during manufacture of a batch of pharmaceutical product by an operator to check whether a piece of equipment has been set up correctly to carry out a manufacturing process step, wherein the equipment set up involves correct operation of a spray nozzle, the process controlling computer apparatus being configured to;

establish a data communication connection to a portable computer apparatus of an operator;

receive scene image data from the operator's portable computer apparatus of an image captured by the operator's portable computer apparatus of a spray emission from the nozzle;

process the received scene image data to assess whether the spray emission has a shape that falls within specification; and

transmit data to the operator's portable computer apparatus conveying an indication of whether the spray emission has a shape that falls within specification.

17 . The computer apparatus of claim 16 ,

wherein the process controlling computer apparatus is further configured to generate a batch record, BR, during manufacture of the batch of pharmaceutical product by populating a master batch record MBR, the process controlling computer apparatus further 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, and the manufacturing process steps including said one relating to the equipment set up;

a mapping data structure that provides links between ones of the operator actions to ones of the content items and associated fields;

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 process controlling computer apparatus being configured to:

transmit image data to the operator's portable computer apparatus, the image data presenting ones of the content items and associated fields to the operator in a way that follows the operator's progression through the operator actions as determined with reference to the mapping data structure and that is responsive to the operator populating the MBR fields; and

populate fields of the MBR, as presented to the operator in the image data, responsive to receipt of the user interface commands.

18 . The computer apparatus of claim 16 , wherein the operator's portable computer apparatus is an augmented reality headset.

19 . The computer apparatus of claim 16 , wherein the operator's portable computer apparatus is selected from the group consisting of: a tablet computer, a mobile phone and a laptop computer.

20 . A computer-implemented process for providing a process control function with a computer apparatus during manufacture of a batch of pharmaceutical product to check whether a piece of equipment has been set up correctly to carry out a manufacturing process step, the process comprising:

establishing a data communication connection between the process controlling computer apparatus and a portable computer apparatus of an operator;

transmitting scene image data from the operator's portable computer apparatus to the process controlling computer apparatus of an image captured by the operator's portable computer apparatus;

processing the received scene image data by the process controlling computer apparatus to identify an image of the piece of equipment and attempting to segment a pre-defined plurality of objects from the equipment image, and making a determination of its correct or incorrect set up by checking each segmented object; and

transmitting data from the process controlling computer apparatus to the operator's portable computer apparatus conveying an indication of the correct or incorrect set up, wherein the transmitted data includes image data for the operator's portable computer apparatus to augment the scene by providing an indication of at least incorrectly set up segmented objects, and wherein the transmitted data includes an indication of any of the pre-defined objects that the process controlling computer apparatus was unable to segment from the equipment image.

21 . The computer-implemented process of claim 20 , wherein the operator's portable computer apparatus is selected from the group consisting of: an augmented reality headset, a tablet computer, a mobile phone and a laptop computer.

22 . A non-transitory computer readable medium storing instructions for performing a computer-implemented process on a computer apparatus for providing a process control function during manufacture of a batch of pharmaceutical product to check whether a piece of equipment has been set up correctly to carry out a manufacturing process step, the instructions comprising:

one or more instructions which, when executed by one or more processors, cause the one or more processors to:

establish a data communication connection between the process controlling computer apparatus and a portable computer apparatus of an operator;

transmit scene image data from the operator's portable computer apparatus to the process controlling computer apparatus of an image captured by the operator's portable computer apparatus;

process the received scene image data by the process controlling computer apparatus to identify an image of the piece of equipment and attempt to segment a pre-defined plurality of objects from the equipment image, and make a determination of its correct or incorrect set up by checking each segmented object; and

transmit data from the process controlling computer apparatus to the operator's portable computer apparatus conveying an indication of the correct or incorrect set up, wherein the transmitted data includes image data for the operator's portable computer apparatus to augment the scene by providing an indication of at least incorrectly set up segmented objects, and wherein the transmitted data includes an indication of any of the pre-defined objects that the process controlling computer apparatus was unable to segment from the equipment image.

23 . The non-transitory computer readable medium of claim 22 , wherein the operator's portable computer apparatus is selected from the group consisting of: an augmented reality headset, a tablet computer, a mobile phone and a laptop computer.