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Feed control scenarios · BR-UP-01

OPT-104AWAITING_TECHNICAL_REVIEWScenario Estimate (Illustrative — Non-Autonomous)

Three ways to respond to late-phase feed attenuation, compared on expected yield effect, risk and practical constraints. Predicted recovery for Candidate A: +5.1 pts normalized yield (range +3.2 to +6.8).

From investigation INV-104 · hypothesis AModel: AN-104 feed-loss regression v1 (3 batches)Demo · read-only
Frame OPT-01

These are illustrative estimates, not predictions you can bank on

Estimates rest on three batches and on hypothesis A, which is supported but not yet tested. Submitting sends the proposal for human review; it does not change the recipe, DeltaV configuration or equipment.

Parameter deltas

What each scenario changes relative to the current recipe

ParameterBaselineCandidate ACandidate B
Feed control mode Open-loop RPMMass-balance cascadeOpen-loop RPM + offset
Feed setpoint (mL/min)16.9016.9016.90
Pump speed (RPM)184.2 fixed172–196 (controller)212 fixed
Gravimetric trim interval (s)—2—
Head-pressure action at 1.20 bar Alarm onlyAlarm + RPM holdAlarm only
Projected peak head pressure (bar)1.48 (observed)≤ 1.151.35
Tubing changeout interval (h)500400500 (OEM life shortened)

Risk matrix

Likelihood × severity of an adverse process outcome · team judgement

LowMediumHighMinorModerateMajorSEVERITYLIKELIHOOD0AB
  • 0 Baseline — feed shortfall likely to recur; moderate yield impact.
  • A Controller mis-tuning possible but bounded by RPM and pressure limits.
  • B Tubing rupture or spallation risk; major impact.

Placements are a qualitative MSAT assessment, not a computed probability.

Practical constraints · Candidate A

  • Pump speed within OEM tubing limit (≤ 200 RPM)
  • Head pressure stays below the 1.20 bar ceiling
  • Feed-tote load cell LC-204 installed on BR-UP-01 skid
  • LC-204 calibration current
  • DeltaV cascade block available in the current control-system version
  • Change control raised for recipe and control strategy
  • Durham recipient loop can be mapped (TT-006 item 2.7)
  • Operator training on new alarm response

4 met · 3 open · 1 unverified. Open items must close before implementation, not before review.

Assumptions

  1. Feed-loss-to-yield relationship from AN-104 (3 batches) holds for future batches; small sample, wide uncertainty.
  2. Hypothesis A (tubing slip) is the main driver of the feed shortfall. If tests TP-01/TP-02 contradict it, this estimate no longer applies.
  3. Controller holds delivered mass within ±2% of setpoint; tuning not yet tested on this skid.
  4. No change to media, cell line, temperature profile or harvest timing.
  5. Range reflects bootstrap resampling of the 3-batch fit (5th–95th percentile); it is not a probability that the outcome will fall inside it.

Outcome measure after implementation

Primary: |feed PV − SP| ≤ 3% throughout Phase 05 on the next 3 batches.

Secondary: PM-204 head pressure ≤ 1.20 bar; normalized yield index compared against the +3.2 to +6.8 pt estimate.

Review point: after MES-26076 harvest. If yield gain is below +3.2 pts, revisit hypothesis A.

Status tracking

ProposedApproved —Implemented —Effect observed —

Proposal · Candidate A

What reviewers are being asked to evaluate

ProposalProposed · not approved · not executed
Rationale
Feed shortfall tracks head pressure (R² = 0.941, correlation) and the tubing-slip mechanism is plausible. A mass-balance loop corrects delivered feed regardless of tubing condition.
Expected result
+5.1 pts normalized yield (illustrative range +3.2 to +6.8) and feed delivery within ±3% of setpoint.
Constraints
Change control, LC-204 calibration check, operator training and Durham loop mapping (TT-006) remain open.
Owner
Alex Rivera (MSAT Lead) with Automation Engineering
Required approval
Technical review (MSAT + Automation) then QA review with named e-signatures in REV-01.
Would change this proposal
Test TP-01 showing no slip at 0.55 N·m; controller trial showing oscillation or pressure overshoot; a new batch with full feed delivery but persistent yield loss.