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Mesa 500L single-use → Durham 2000L stainless

TT-006Gate 2 blocker

AB-mAb-014 upstream transfer. Gate 2 Clearance (Engineering & CPP Dossier). Side-by-side comparison of donor and recipient equipment, with gaps and unknowns shown explicitly.

Gates
  1. G0 Feasibility: cleared
  2. G1 Process & analytics: cleared
  3. G2 Engineering & CPP dossier: blocked
  4. G3 Engineering run: not started
  5. G4 PPQ readiness: not started
Lead Alex RiveraDemo · read-only
Draft transfer plan Propose recipe delta
Frame TRANSFER-02

Scale factor

Calculated

1:4.00

2000 L / 500 L working volume

Volumetric power (donor)

Observation

42.8W/m³

Recipient not measured

Unresolved blocker

Durham PID cascade tuning constants unmapped

Owner K. Osei · due 2026-11-06

Donor · Mesa 500L single-use

EQ-SPEC-MESA-SUB500 Rev 3

PWTgravimetriccascadeH/D 1.5500 L working · single-usePBT 45° · drilled-hole sparger

Recipient · Durham 2000L stainless

EQ-SPEC-DUR-SS2000 Rev 1 (2023 · may be stale)

PFICflow-onlyPID unmappedH/D 2.02000 L working · stainlessRushton + PBT · ring sparger

Schematics are simplified and drawn to relative vessel scale only. Orange line = feed path; dashed red controller = unmapped loop.

Parameter comparability

Status per parameter. Unknowns stay unknown until a source supplies them.

ParameterMesa 500LDurham 2000LStatusNote
Working volume500 L2000 LScaledCalculatedScale factor 1:4.00
Aspect ratio H/D1.52.0GapObservationTaller vessel: longer mixing time and higher hydrostatic head at sparger
Impeller1 × PBT 45°, D/T 0.33Rushton + PBT, D/T 0.35GapObservationDifferent power number; Rushton adds radial shear
Tip speed1.38 m/s @ 160 rpmNot setUnknownUnknownDepends on Durham agitation setpoint, not yet chosen
Power per volume P/V42.8 W/m³ (measured)42.8 W/m³ (design basis)ScaledCalculatedConstant-P/V basis is a target; Durham value not measured
kLa (air)8.4 h⁻¹UnknownUnknownUnknownCharacterisation report ENG-RPT-0447 not issued
Aeration (VVM)0.05 vvm0.05 vvm (planned)MatchObservationSame VVM; different sparger bubble size
Feed control loopGravimetric cascade (DeltaV v14)Flow-only FIC-2201 (DeltaV v13) · PID constants unmappedGapObservationGate 2 blocker

Gate 2 readiness checklist

2 done · 2 in progress · 1 blocked · 3 not started

  • Process description & CPP list transferred

    Done

    Alex Rivera · MSAT

  • Analytical methods transferred (titer, VCD)

    Done

    K. Osei · QC Durham

  • Equipment equivalency assessment

    In progress

    R. Chen · Engineering

  • Feed-loop PID cascade constants mapped (FIC-2201)

    Blocked

    K. Osei · Durham Automation

  • kLa characterisation at 2000 L (ENG-RPT-0447)

    Not started

    Durham Engineering

  • Recipe translation RCP-AB014 → Durham DeltaV v13

    Not started

    Alex Rivera · MSAT

  • Transfer risk assessment (FMEA)

    In progress

    D. Kim · QA

  • Gate 2 dossier QA review

    Not started

    Priya Natarajan · QA

No readiness score is computed. Gate clearance is decided by the Gate 2 review board.