One avoided rejected batch on a high-value product can pay for months of the Line tier. We would rather you started with one line and one number than with a plant-wide programme and a business case nobody believes.
Scenario: Run one immediate-release tablet batch through granulation, compression, coating and inspection inside the approved design space, with QA approval before release. A design walkthrough, not a customer record.
Land on one validated workflow with a measurable baseline. Expand by line, module, site and autonomy level. Outcome components are available on yield, rejects, deviations and energy.
Compression or coating control or inspection AI for one line. For OSD makers validating ROI on the wedge.
The whole loop: blend and dispense, granulate and dry, compress and fill, coat and dry, defect, quality and potency, yield and takt, robotic handling and the batch twin.
Pharma and CDMO groups standardising on Pildeon across sites, with custom formulation, tooling and tolerance models.
Annual prepay discounts run 15 to 20% depending on term; the toggle shows 15%. Usage metering applies above plan limits. Multi-year enterprise agreements carry usage ramps.
Modules are licensed per line on the Line tier and bundled on Plant and Enterprise.
| Capability | Line | Plant | Enterprise |
|---|---|---|---|
| Lines covered | 1 | All on site | All in group |
| Agent modules | 1 of 9 | All 9 | All 9 + custom |
| Twindra batch twin | · | Included | Custom formulation and tooling models |
| Spectryn, Visqa, Conforma, Kinetos | One module (Spectryn or Visqa or control) | All included | All included |
| Plant-edge node | Included | Per line | Fleet managed |
| Bounded equipment writes | Scoped setpoints | All scoped setpoints | Group policy |
| Part 11 audit trail and genealogy | Included | Included | Included + export API |
| Autonomy levels | L0 to L2 | L0 to L3 | L0 to L3, group policy |
| SSO, RBAC | · | SSO | SSO + RBAC to the setpoint |
| Validated on-prem, air-gapped | · | Optional | Included |
| Validation artefacts | Model cards | Model cards + change-control records | Full site validation package |
| Support | Business hours | 24/7 | 24/7 + named engineer |
| Model review | Annual | Quarterly | Quarterly per site |
| Indicative price | $17,000/mo | $100,000/mo | $750k to $10M ACV |
For the highest-value workflows, enterprise agreements can include an outcome component: a share of measured yield, reject, deviation, energy or first-pass-quality improvement against the shadow-mode baseline. The baseline method is agreed in writing first.
Per batch, per line or per action above plan limits, so a growing campaign does not need a new contract.
Only against a baseline both sides signed, only on numbers reproducible from the plant's own records.
Discounts are traded for term length and case-study rights, never for a weaker baseline method.
A run engine that produces this record on every batch, every shift, on every line you license.
Plant Orchestrator · Pulled the master batch record, the approved design-space limits for this formulation and tooling family, and the site autonomy policy from MES; locked the target envelope for the run.
Plant Orchestrator · Twindra simulated 36 candidate setpoint vectors on the as-made batch twin (granulation DEM, compression and ejection risk, coating CFD, dissolution surrogate) and ranked them on predicted content uniformity, capping risk and takt.
Blend-and-Dispense · Spectryn scored in-line NIR spectra against the formulation's chemometric model; the blend reached its uniformity end point with confidence bounds inside the site acceptance limit and blending stopped on evidence rather than on a fixed time.
Granulate-and-Dry · Inlet air temperature and drying airflow trimmed inside the approved window to bring loss-on-drying to the target moisture band for compression; the move was bounded, logged and inside the design space.
Compress-and-Fill · Main compression force and feed-frame speed adjusted inside the approved window to hold tablet weight and hardness on target while the twin's capping-risk estimate stayed under the site threshold.
Coat-and-Dry · Spray rate and inlet temperature re-phased against bed temperature and exhaust humidity to hold the film-coat window and avoid twinning and mottling; no excursion from the validated recipe envelope.
Defect-and-Inspect · Visqa classified chips, cracks, capping, spots, mottling and print defects on six synchronised cameras, within the sub-100 ms design budget, and linked a rising chip rate to coating spray rather than to tooling.
Quality-and-Potency · Spectryn assembled the method-linked evidence chain for content uniformity and moisture with confidence bounds and citations to the validated analytical method, ready for QA review.
Plant Orchestrator · Batch release is above every autonomy level Pildeon offers. The package was held for the named QA reviewer, who approved it in the review console; the decision, the reviewer identity and the timestamp are in the Part 11 audit trail.
Quality-and-Conformance · Conforma wrote the time-aligned batch genealogy (every sensor state, recommendation, approved action, equipment response and QC result) and the cited release package to the immutable audit trail.
Every tool invocation, argument and result is written to an immutable, human-readable log, and every reasoning step is expandable. Nothing about a run is hidden from the plant or from QA.
Plan, thought, action, observation, exactly as the orchestrator records it.
Run one immediate-release tablet batch through granulation, compression, coating and inspection inside the approved design space, with QA approval before release.
Rehearse on the twin first. Stop blending on NIR evidence rather than on a fixed time. Trim drying, compression and coating only inside the approved design space. Inspect continuously. Hold release for the named QA reviewer, always.
The fixed recipe blends for a set time regardless of what the spectra say. On the twin, the candidate that stops on evidence and trims inlet temperature before compression keeps content uniformity and moisture inside their limits with the lowest predicted capping risk.
twin.simulate(candidates=36) → candidate #14: evidence-based blend end point, bounded drying trim, compression force held inside the window, spray rate re-phased to bed temperature.
Every candidate that pushed turret speed for takt raised predicted capping risk above the site threshold and was discarded. Rate is never traded for a quality attribute.
Execute candidate #14 under autonomy level L2: five setpoint moves inside the design space, each logged. Batch release routed to QA.
Chip rate rose on camera 4 at 06:27:10. Visqa attributed it to coating spray rather than tooling; a bounded spray-rate trim returned it to baseline in about two minutes.
Scenario complete. Every move inside the approved design space, the QA approval recorded with identity and timestamp, and the cited release package written by Conforma to the immutable audit trail.
Cost, trial, ownership, risk and how to start.
Line tier $17,000 per compression, coating or granulation line per month; Plant tier $100,000 per month for the whole loop; Enterprise custom, landing between $750k and $10M annual contract value. Annual prepay saves 15 to 20%. Outcome components are available.
Shadow-mode instrumentation for design partners is at no charge. A paid validated pilot follows only when there is a written ROI target.
You own your data. Models fitted on your data are yours to use inside Pildeon and are never used for another tenant. Validation artefacts are delivered to you.
The pharma sales and validation cycle is long; robotics is capital-intensive; per-formulation calibration and surrogate accuracy are targets until measured. We mitigate with a shadow-to-pilot motion and staged autonomy, and we say so.
You keep the baseline report, the validation artefacts produced so far and your data. Connectors are removed under change control.
Book a line review. Bring the line, the number that hurts and the names of your MSAT champion and QA reviewer.
Pildeon writes to production equipment in a GMP plant. Every capability is scoped to the approved design space, every write is policy-checked, every action is written to an immutable Part 11 audit trail the site owns, and no agent can release a batch.
| Standard | Scope | Status |
|---|---|---|
| 21 CFR Part 11 | Audit trail, e-signatures, records | RUNNING Designed in from day one |
| GAMP 5 | Validation package for the platform | RUNNING In progress, planned for the first design partners |
| cGMP · ICH Q8 to Q13 | Design space, QbD, continuous manufacturing | RUNNING Design-aligned; site validation decides |
| SOC 2 Type I | Cloud control plane | QUEUED Planned, first six months |
| SOC 2 Type II | Cloud control plane | QUEUED Planned, months six to twelve |
| Data residency | Validated on-prem, air-gapped option | SUCCEEDED Available by design |
One policy model, one audit spine, one benchmark across every line in every plant, with formulation and tooling models kept private to each site.
Pildeon has no customer quotes to show yet, and will not invent any. These are the questions the three buyers in an OSD plant ask in the first meeting, and the answer each gets.
"What does this do to my reject rate, my deviation count and my release time, and how will you prove it on my line rather than on a slide?"
Site or manufacturing director · economic buyerAnswer: shadow mode first, baseline captured before any autonomous action, a written ROI target before a paid pilot.
"Will it ever move a setpoint outside the design space we validated, and can I see why it recommended every move it made?"
Formulation or process engineer (MSAT) · championAnswer: no, by construction. Every recommendation carries its reasoning trace and its citation.
"Where is the Part 11 audit trail, who signs the release, and what happens to my validated state when the model changes?"
QA, quality and compliance lead · approverAnswer: an immutable audit spine, a named QA reviewer on every release, and every model change under GxP change control.
Shadow mode is free for design partners. The Line tier starts when the written metric says it should.
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