System

MBSE review session for {{entity:Pharmaceutical Manufacturing Line}} (se-pharma-manufacturing). Audited 6 existing diagrams — a misleading diag list report showed all diagrams at 0 blocks, but diag get confirmed actual content across the board. The primary defect found and fixed was the context diagram, which had 12 actor and external-system blocks but zero connectors. Three further structural issues were catalogued: duplicate block sets in the decomposition diagram, duplicate component sets in the PAT and MES internal diagrams, and four subsystems with no internal diagram at all because component-level decomposition hasn’t yet been done.

Diagrams

flowchart TB
  n0["system - Pharmaceutical Manufacturing Line"]
  n1["actor - Production Supervisor"]
  n2["actor - QC Analyst"]
  n3["actor - Maintenance Technician"]
  n4["actor - EHS Officer"]
  n5["actor - Material Handler"]
  n6["actor - Regulatory Inspector"]
  n7["system - ERP System"]
  n8["system - LIMS"]
  n9["system - Building Utilities"]
  n10["system - Serialisation System"]
  n11["actor - Patient"]
  n0 -->|batch records and consumption outbound| n7
  n7 -->|production orders and BOM inbound| n0
  n0 -->|sample requests outbound| n8
  n8 -->|test results and disposition inbound| n0
  n9 -->|HVAC purified water compressed air nitrogen| n0
  n0 -->|EPCIS events and serial number requests| n10
  n10 -->|unique identifiers inbound| n0
  n1 -->|batch release decisions and production control| n0
  n2 -->|in-process and release testing| n0
  n3 -->|maintenance and LOTO procedures| n0
  n4 -->|EHS oversight and incident reporting| n0
  n5 -->|raw material dispensing and transfer| n0
  n6 -->|GMP audit and 21 CFR Part 11 inspection| n0
  n0 -->|finished pharmaceutical product| n11

flowchart TB
  n0["system - Pharmaceutical Manufacturing Line"]
  n9["subsystem - Material Handling and Dispensing Subsystem"]
  n10["subsystem - Granulation and Blending Subsystem"]
  n11["subsystem - Tablet Compression Subsystem"]
  n12["subsystem - Process Analytical Technology Subsystem"]
  n13["subsystem - Film Coating Subsystem"]
  n14["subsystem - Containment and Environmental Control Subsystem"]
  n15["subsystem - Packaging and Serialisation Subsystem"]
  n0 -->|CONTAINS| n9
  n0 -->|CONTAINS| n10
  n0 -->|CONTAINS| n11
  n0 -->|CONTAINS| n12
  n0 -->|CONTAINS| n13
  n0 -->|CONTAINS| n14
  n0 -->|CONTAINS| n15
  n9 -->|weighed API and excipients| n10
  n10 -->|dried granulate target PSD| n11
  n11 -->|tablet cores| n13
  n13 -->|coated tablets| n15
  n10 -->|in-process samples NIR/Raman| n12
  n14 -->|conditioned air and pressure differential| n10

flowchart TB
  n7["component - PAT NIR Spectrometer"]
  n8["component - PAT Raman Spectrometer"]
  n9["component - PAT Laser Diffraction Analyser"]
  n10["component - PAT Data Acquisition and Processing Workstation"]
  n11["component - PAT CQA Model Engine"]
  n12["component - PAT Batch Diversion Valve Assembly"]
  n6["external - MES (External)"]
  n7 -->|NIR spectra 400-2500nm, 30s cycle| n10
  n8 -->|Raman spectra 785nm, 60s cycle| n10
  n9 -->|PSD data D10/D50/D90 at 2Hz| n10
  n11 -->|validated chemometric model predictions| n10
  n10 -->|diversion command on CQA fail SIL 3, 2s| n12
  n10 -->|OPC-UA: CQA alarm, health| n6

flowchart TB
  n7["component - MES Electronic Batch Record Engine"]
  n8["component - MES Electronic Signature Controller"]
  n9["component - MES Hash Chain Integrity Engine"]
  n10["component - MES LOTO Registry Module"]
  n5["external - PAT Subsystem (External)"]
  n6["external - ERP/SAP (External)"]
  n8 -->|signed record with non-repudiation token| n7
  n7 -->|EBR entries and signature events for SHA-256 chaining| n9
  n10 -->|LOTO lock status and isolation point confirmation| n7
  n5 -->|CQA data, alarms| n7
  n7 -->|batch records out| n6

flowchart TB
  n0["component - High Shear Granulator"]
  n1["component - Granule Transfer System"]
  n2["component - Fluid Bed Dryer"]
  n3["component - Granule Sizing Mill"]
  n4["component - IBC Blender"]
  n5["external - MES Recipe Controller"]
  n6["external - PAT DAC Workstation"]
  n0 -->|wet granules| n1
  n1 -->|wet granules| n2
  n2 -->|dried granules| n3
  n3 -->|sized granules| n4
  n5 -.->|recipe control| n0
  n5 -.->|recipe control| n2
  n5 -.->|blend recipe| n4
  n6 -.->|NIR blend endpoint| n4
  n2 -->|LOD NIR signal| n6

flowchart TB
  n0["component - Rotary Tablet Press"]
  n1["component - Tablet IPC System"]
  n2["component - Punch Die Tooling"]
  n3["component - Containment Housing"]
  n4["external - IBC Blender"]
  n5["external - PAT Workstation"]
  n6["external - MES"]
  n4 -->|granule feed| n0
  n0 -->|compression force| n1
  n2 -->|tooling RFID| n0
  n1 -->|OPC-UA weight/hardness| n5
  n1 -->|rejection events| n6
  n3 -.->|guard interlock| n0

Findings

• Context diagram missing all connectors (fixed): All 12 blocks existed but zero flow connectors had been created. Added 14 connectors: bidirectional flows to ERP, LIMS, and Serialisation System; unidirectional utility supply from Building Utilities; six human-actor interactions; and the product delivery arc to Patient.
• Decomposition diagram — duplicate block sets: Two generations of subsystem blocks coexist. The first set uses short names (e.g., “Granulation and Blending”) with null-labelled CONTAINS connectors; the second set uses full entity names matching PART_OF facts (e.g., “Granulation and Blending Subsystem”) with labelled material-flow connectors. Added seven labelled CONTAINS connectors to the canonical set this session. Deduplication by name failed because the names differ; cleanup requires a QC session with explicit list-and-delete logic.
• PAT and MES internal diagrams — same duplication pattern: Both diagrams contain an older block set (short component names) plus a newer set matching PART_OF entity names. The newer blocks carry the correctly specified connectors; the older blocks carry the original simpler connectors. Total redundant blocks: 6 in PAT, 5 in MES.
• Granulation internal — three blocks not in PART_OF: “Granule Transfer System”, “Blending Vessel”, and “Granulation Process Controller PLC” appear in the diagram but have no PART_OF fact in {{entity:Granulation and Blending Subsystem}}. These should either be classified and asserted into the knowledge graph or removed during QC.
• Tablet Compression block names differ from PART_OF entities: “Tablet IPC System”, “Punch Die Tooling”, and “Containment Housing” are shorthands for the PART_OF entities “Tablet In-Process Control System”, “Punch and Die Tooling Set”, and “Tablet Compression Containment Housing”. Not duplicate — but names must be reconciled for cross-reference to work.
• Four subsystems without internal diagrams: {{entity:Material Handling and Dispensing Subsystem}}, {{entity:Film Coating Subsystem}}, {{entity:Containment and Environmental Control Subsystem}}, and {{entity:Packaging and Serialisation Subsystem}} have no child PART_OF facts and therefore no internal component diagrams. These are the next decomposition targets.

Statistics

• Diagrams before: 6, after: 6
• Connectors added: 21 (14 context, 7 decomposition CONTAINS)
• Blocks added: 0 (all blocks were already present)
• Diagrams fully connected (blocks + labelled connectors): 5/6 (context now fixed; decomposition still has unlabelled legacy connectors)
• Subsystems with complete internal diagrams: 4/8

Next

The duplicate block sets across the decomposition, PAT, and MES diagrams need a dedicated QC cleanup: delete the short-name legacy blocks after re-pointing any unique connectors they carry. The four undecomposed subsystems — Material Handling, Film Coating, Containment and Environmental Control, and Packaging and Serialisation — each need component-level classification via Substrate followed by internal diagram population. Material Handling is the highest priority given it is the first process step and feeds every downstream subsystem.