New · Continuous pharma manufacturing

SDE PharmaFlow

A continuous-native automation & analytics layer for pharmaceutical manufacturing—bridging R&D benches, pilot skids, and GMP production with built-in PAT, recipe logic, and 21 CFR Part 11–ready records.

Part of the SDE suite: Control · Trace · Peak

Pharmaflow

Continuous Pharmaceutical Manufacturing Dashboard

Analytics

Equipment

Recipes

System Alerts

⚠️pH deviation in Reactor 2
⏱️Maintenance due: Pump A1

Throughput

120 g/hr

+3.2%

Yield

98.2%

+0.4%

Uptime

99.4%

+0.1%

Compliance checks

42/42

Pass

Process Flow

Feed

Solvent, API, buffer

Reactor

PFR 2 mm · 6 m

Quench

Inline mixer

Separator

Mixer-settler

Purification

Prep HPLC

Tooltips show setpoints, limits, and last deviations. Click a card to drill into trends and controls.

Equipment status

Unit State Setpoint PV
Pump A1 Running 6.00 mL/min 6.02
Reactor T Holding 45.0 °C 45.3
pH Cell R2 Alarm 6.5 ±0.2 7.0

Active alarms

  • pH high deviation · Reactor 2 2m ago

    PV 7.0 vs setpoint 6.5 ±0.2

  • Maintenance due · Pump A1 3d

    Last service 180h

Recipe queue

  1. PF-001 Steady-state Qual

    Targets: 6.0 mL/min · 45 °C · pH 6.5

    Running
  2. PF-002 Ramp-up → Hold

    Flow sweep 4→8 mL/min, hold 20 min

    Queued
  3. PF-003 Fractionation

    Trigger by UV@280 nm > 0.35 AU

    Queued

PAT signals

UV @ 280 nm

Trigger: > 0.35 AU

IR Inline

Endpoint: Abs 1.12 ±0.05

pH

Limit: 6.5 ±0.2

Conductivity

SPC: 3σ bands

Control loops

Flow PID · Pump A1

Auto

SP 6.00 mL/min · PV 6.02 · OP 41%

Temperature PID · Reactor

Auto

SP 45.0 °C · PV 45.3 °C · OP 28%

Electronic Batch Record (EBR)

Record Version Status Updated
PF-001-SS-Run-14 v1.6 Approved Today 14:22
PF-002-Ramp-Run-03 v0.9 Review Yesterday
PF-003-Frac-Run-01 v0.3 Draft 2d

Audit trail

  • 📝

    User A edited Recipe PF-002 setpoints

    14:11 · Fields: flow 5→6 mL/min

  • 🔐

    User B approved EBR PF-001-SS-Run-14

    13:58 · e-signature SHA256: …a91f

  • ⚠️

    Alarm acknowledged: pH high R2

    13:42 · HMI Station 03

Tech specs

  • Backend: Go + HTMX + WebSockets
  • DB: SQLite/Postgres; audit-safe append logs
  • Edge: ESP32 (OTA), Modbus-TCP/RTU, OPC-UA
  • Auth: Users/Roles, e-sig, 21 CFR Part 11
  • Export: PDF, CSV, JSON, EBR bundle

Integrations

  • SDE Control (DCS), SDE Trace (MES/EBR), SDE Peak (HPLC)
  • Inline UV/Vis/IR, pH/Cond, balances, flow meters
  • Preparative HPLC fractionation triggers
  • Label printing & QR batch IDs

Compliance

  • EBR with versioning & approvals
  • Time-stamped, immutable audit trail
  • User/role controls, session timeouts
  • Electronic signatures & reason codes

FAQ

How does PharmaFlow differ from a batch-oriented MES?

It models targets as steady-state windows with ramp/hold/diversion logic rather than forcing batch abstractions, enabling tighter PAT feedback and higher utilization.

Can it run offline at the edge?

Yes—edge nodes buffer data and reconcile on reconnect; core controls remain local for safety.

What’s the migration path from R&D to GMP?

Start with recipe prototypes and PAT wiring, then enable approvals, e-signatures, and EBR when moving to pilot/GMP.