SOL-001 / REPRESENTATIVE SCOPEBiopharma / Clean Utilities
PW/WFI Distribution Skid — I&C Documentation
PW loop, WFI circulation, conductivity, TOC, flow/temperature transmitters, valve manifolds
Typical contractor deliverables- Instrument Index
- I/O List
- loop diagrams
- termination schedule
- vendor-document review
Engineering / product referencesEudraLex Volume 4 Annexes 11/15 where GxP applies; ISPE GAMP 5 (guidance); IEC 81346
Local/site contextI.S. 10101 applies where site electrical installation work is included
SOL-002 / REPRESENTATIVE SCOPEBiopharma / Clean Utilities
CIP/SIP Skid — Electrical & Instrumentation Package
CIP supply/return, caustic/acid dosing, steam valves, temperature, conductivity
Typical contractor deliverables- Instrument List
- valve/I/O matrix
- control-panel wiring
- cable/terminal schedules
Engineering / product referencesEudraLex Volume 4 Annexes 11/15 where GxP applies; ISPE GAMP 5 (guidance); EN IEC 60204-1 for machinery
Local/site contextI.S. 10101 for fixed electrical installations
SOL-003 / REPRESENTATIVE SCOPEBioprocess OEM
Buffer Preparation / Mixing Skid Controls
mixing vessel, load cells, agitator VFD, pH probes, pumps
Typical contractor deliverables- PLC panel schematics
- I/O
- instrument datasheet check
- BOM
Engineering / product referencesEudraLex Volume 4 Annexes 11/15 where GxP applies; ISPE GAMP 5 (guidance); EN IEC 60204-1
Local/site contextI.S. 10101 (site installation only)