RippleFlo
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Industry
PharmaCriticalAerospaceProcessDiscreteMedical

Medical device manufacturing demands traceability — ERP can't simulate the validation path.

Cleanroom assembly, sterilization holds, and validation gates create ripples ERP never models. RippleFlo traces every lot from PO to release with audit-grade replay.

ERP / MES in medical devices

Tracks lots. Can't model validation chains.

Medical device manufacturing requires validated processes, sterilization holds, and QC gates. ERP schedules operations — it doesn't simulate how a sterilization delay ripples to release.

  • Sterilization holds applied as fixed offsets
  • Cannot model cleanroom capacity and queue contention
  • Validation review triggered at release — not proactively
  • CAPA-style schedule changes lack pre-commit evidence
RippleFlo for medical devices

Simulates the validated path.

Component prep through cleanroom, assembly, sterilization, validation QC, and release — with pegging trees and deterministic replay for quality review.

  • Sterilization hold and cleanroom queue modeling
  • Validation gate risk scoring before release review
  • Pegging tree from PO → lot → operation → root cause
  • CAPA-style pre-commit blast preview

Medical device manufacturing — ERP vs RippleFlo

DimensionERP / MESRippleFlo
Release schedulingFixed validation lead timeDES with hold & gate modeling
SterilizationStatic hold offsetDynamic hold chain ripples
Cleanroom capacityAssumes availableQueue contention simulated
Validation riskFound at sign-offAmber/red scoring earlier
Lot traceabilityBatch record lookupLive pegging tree + archive
Equipment failurePost-event logMTBF/MTTR in simulation
Audit trailManual reconstructionDeterministic replay + diff
What-if costChange live lotRe-run model — zero risk

Watch a medical device lot ripple through validation.

Assembly queues. Sterilization extends. Release review turns amber — before the CAPA meeting.

Lot MD-04 · Assembly → Release· DES tick 11:28:15
Component Prep
30m/lot · buf 2
In process
Cleanroom
2h/lot · buf 4
In process
Assembly
4h/lot · buf 3
Queue build
Sterilization
6h hold · buf 2
Ripple slip
QC Validation
8h/lot · buf 3
On hold
Labeling
1h/lot · buf 2
In process
Lot Release
Window Dec 3
At risk
Distribute
Due Dec 5
At risk
Ripple trace · Sterilization
Hold extended +8h
MD-04 slip +1d · Release Dec 2 → Dec 3
Validation risk
At risk
2 lots in hold · 1 past window
Line WIP
4 lots
+1 vs plan
Cleanroom util
89%
near capacity
Sterile hold
8h
+8h extended
Release
Dec 3
1d slip risk
Lot slip · Sterilization delay
MD-01
+0h
MD-02
+2h
MD-03
+6h
MD-04
+1d
MD-05
+2d

How RippleFlo solves what ERP cannot in medical devices.

Validated manufacturing paths need simulation-backed schedule evidence.

Validation risk scoring

Flag lots at risk before release review — planning and quality see the same alert.

Sterilization hold chains

Trace how hold extensions ripple through labeling and release.

CAPA-ready preview

Pre-commit blast shows which lots shift before QA signs off.

Pegging tree export

PO → lot → operation → root cause for quality and regulatory review.

Alternate validated routes

Route through qualified alternates when primary line is down.

Deterministic replay

Re-run any historical lot scenario with identical inputs.

Sterilization extended 8 hours. Four lots. Four different release paths.

ERP shifts all lots equally. RippleFlo measures slip per lot against its validation window — MD-04 slips 1 day while MD-01 clears QC before the hold peaked.

  • Per-lot slip with attribution (% sterilization vs assembly queue)
  • Stage-to-stage trace through validation gates
  • Pre-commit preview before QA release sign-off
Demo a medical device line
pegging.trace · MD-04
PO #7701 · Customer MedTech Inc
└─ Lot MD-04 · Release Dec 3
└─ 1d slip
└─ Sterilization hold +8h
└─ Assembly queue +4h
└─ Alt cleanroom route
└─ Audit entry #33401 ✓