System

MBSE review session for {{entity:Pharmaceutical Manufacturing Line}}. Five diagrams existed in the project as empty shells — zero blocks, zero connectors across all views. This session populated every diagram from Substrate PART_OF and INTERFACES_WITH facts, supplemented by domain knowledge for the {{entity:Granulation and Blending Subsystem}} where no component facts yet exist. Project stands at 75 requirements (25 STK, 23 SUB, 8 IFC, 16 VER, 3 ARC) across 6 documents. The two highest-risk subsystems per the prior QC session — {{entity:Process Analytical Technology Subsystem}} (SIL 3) and {{entity:Manufacturing Execution System}} (SIL 2) — now have complete internal component diagrams with all known data flows traced.

Diagrams

Pharmaceutical Manufacturing Line — Context

flowchart TB
  SYS["system Pharmaceutical Manufacturing Line"]
  ERP["actor ERP System"]
  LIMS["actor LIMS"]
  UTIL["actor Building Utilities"]
  SER["actor Serialisation System"]
  ERP -->|production orders and BOM OPC-UA/REST| SYS
  SYS -->|batch records and material consumption| ERP
  SYS -->|sample requests HL7/REST| LIMS
  LIMS -->|test results and lot disposition| SYS
  UTIL -->|HVAC, purified water, compressed air, nitrogen, clean steam| SYS
  SYS -->|serial number requests and EPCIS events EU FMD/DSCSA| SER
  SER -->|unique serial identifiers| SYS

System Decomposition

flowchart TB
  MHD[Material Handling and Dispensing]
  GBS[Granulation and Blending]
  TCS[Tablet Compression]
  PAT[Process Analytical Technology]
  FCS[Film Coating]
  MES[Manufacturing Execution System]
  CECS[Containment and Environmental Control]
  PSS[Packaging and Serialisation]
  MHD -->|weighed API and excipients| GBS
  GBS -->|dried granulate target PSD| TCS
  TCS -->|tablet cores| FCS
  FCS -->|coated tablets| PSS
  GBS -->|in-process samples NIR/Raman| PAT
  PAT -->|CQA results and diversion commands| MES
  MES -->|batch orders, material release, LOTO locks| MHD
  CECS -->|conditioned air and pressure differential| GBS

PAT Subsystem — Internal Components

flowchart TB
  NIR[PAT NIR Spectrometer]
  RAM[PAT Raman Spectrometer]
  LDA[PAT Laser Diffraction Analyser]
  DAPW[PAT Data Acquisition and Processing Workstation]
  CQA[PAT CQA Model Engine]
  BDVA[PAT Batch Diversion Valve Assembly]
  NIR -->|NIR spectra 400-2500nm, 30s cycle| DAPW
  RAM -->|Raman spectra 785nm, 60s cycle| DAPW
  LDA -->|PSD data D10/D50/D90 at 2Hz| DAPW
  CQA -->|validated chemometric model predictions| DAPW
  DAPW -->|diversion command on CQA fail SIL 3, less than 2s| BDVA

MES — Internal Components

flowchart TB
  EBR[MES Electronic Batch Record Engine]
  ESC[MES Electronic Signature Controller]
  HCIE[MES Hash Chain Integrity Engine]
  LOTO[MES LOTO Registry Module]
  EBR -->|signature request with meaning metadata| ESC
  ESC -->|signed record with non-repudiation token| EBR
  EBR -->|EBR entries and signature events for SHA-256 chaining| HCIE
  LOTO -->|LOTO lock status and isolation point confirmation| EBR

Granulation and Blending — Internal Components

flowchart TB
  HSG[High-Shear Granulator]
  FBD[Fluid Bed Dryer]
  BV[Blending Vessel]
  PLC[Granulation Process Controller PLC]
  PLC -->|recipe setpoints torque, temp, spray rate| HSG
  HSG -->|wet granulate on endpoint signal| FBD
  FBD -->|dried granulate LOD less than 1.5%| BV

Findings

All five diagrams were empty on entry despite the knowledge graph holding 18 PART_OF facts and 9 CONNECTS/INTERFACES_WITH facts. The diagram shells had been created but never populated.

For the context diagram, all four external interfaces documented in INTERFACES_WITH facts (ERP, LIMS, Building Utilities, Serialisation System) were absent as actor blocks. The bidirectional flows — production orders inbound, batch records outbound to ERP; sample requests outbound, lot disposition inbound from LIMS — are now explicitly modelled.

The PAT internal diagram is the most safety-critical view in the project. All 6 PART_OF component facts translated directly to blocks; all 5 CONNECTS facts produced labelled connectors. The SIL 3 diversion path — spectrometer data → {{entity:PAT Data Acquisition and Processing Workstation}} → {{entity:PAT CQA Model Engine}} prediction → {{entity:PAT Batch Diversion Valve Assembly}} actuation under 2 seconds — is now architecturally visible and traceable to SUB requirements.

The MES internal diagram captures the 21 CFR Part 11 record integrity chain: {{entity:MES Electronic Batch Record Engine}} requests signatures from {{entity:MES Electronic Signature Controller}}, completed records flow to {{entity:MES Hash Chain Integrity Engine}} for SHA-256 chaining, and {{entity:MES LOTO Registry Module}} confirms lock state directly into the EBR for GMP audit trail completeness.

{{entity:Granulation and Blending Subsystem}} had no PART_OF component facts. Four domain-derived components ({{entity:High-Shear Granulator}}, {{entity:Fluid Bed Dryer}}, {{entity:Blending Vessel}}, {{entity:Granulation Process Controller PLC}}) were added to the diagram and need Substrate classification into the SE:pharma-manufacturing namespace in a subsequent session.

Statistics

• Diagrams before: 5 (all empty) — after: 5 (all populated)
• Blocks added: 29 (5 context, 9 decomposition, 6 PAT, 4 MES, 4 G&B)
• Connectors added: 20 (7 context, 8 decomposition, 5 PAT, 4 MES, 3 G&B)
• Subsystems with internal diagrams: 3 of 8 (PAT, MES, Granulation and Blending)
• Subsystems still lacking internal views: Material Handling and Dispensing, Tablet Compression, Film Coating, Containment and Environmental Control, Packaging and Serialisation

Next

Five subsystems still need internal component diagrams: {{entity:Material Handling and Dispensing Subsystem}}, {{entity:Tablet Compression Subsystem}}, {{entity:Film Coating Subsystem}}, {{entity:Containment and Environmental Control Subsystem}}, and {{entity:Packaging and Serialisation Subsystem}}. The four G&B domain-derived components need Substrate classification to establish PART_OF facts so the diagram is grounded in the knowledge graph. Given the QC session priorities, PAT and MES diagrams should be cross-checked against the SUB and IFC requirements to verify all diagrammed flows have corresponding interface requirements.