Pharmaceutical sector
Industrial AI for pharma — without breaking GMP or 21 CFR Part 11
iLEAN digitizes the pharmaceutical plant without touching the qualified systems: the batch record leaves the paper, vision inspects 100% of the units, cleaning is validated with evidence and the auditor downloads the dossier from the web. Compliance by design — an immutable audit trail, ALCOA+ data integrity and a 21 CFR Part 11 electronic signature on every capture.
Full index
All 65 cases in pharma
The complete listing, unpaginated. Each link goes to the specific case: the problem as it shows up on the plant floor, how the IRIS schema solves it and what was measured.
- A pre-inspection evidence pack for FDA, COFEPRIS and ANVISA — zero documentary reconstruction
- AI cold chain for vaccines and biologics — one hour short of −70 °C does not show up on the label.
- AI control of pharma WFI water — the invisible utility that decides the batch.
- AI for veterinary pharma — multi-species, multi-dose, a single safety net.
- AI mRNA vaccine control — a batch is not signed off on hunches.
- AI nasal spray control — a crimp out of height is a dose out of specification.
- AI suppository manufacturing control — one degree less in the mass is a run of weights out of spec.
- AI-assisted CIP/SIP on direct impact equipment — an excursion you see coming never becomes a deviation.
- An always-ready FDA/EMA audit — the inspection walks in “prepared” because the evidence is live, not filed away.
- Annex 1 2023 with AI in sterile packaging — CCS, EM and QRM stopped being paperwork.
- Annex 11 with AI — every change triggers revalidation, and your quality team can no longer keep up.
- API + excipient blending with AI — content uniformity is confirmed in the blender, not in the lab.
- Aseptic eye drop filling with AI — contamination is not detected in QC, it is prevented at second zero.
- Aseptic eye drops control with AI — sterility is not tested at the end: it is built into every minute of the fill.
- Aseptic packaging with AI vision — a vial with a particle is not an incident, it is a recalled batch.
- ATMP vein-to-vein custody chain — a lost CAR-T is not an incident, it is a patient without treatment.
- Autoinjector pen control with AI — the patient activates it alone, so the assembly leaves no room for doubt.
- Cleaning between hormonal products validated by Edge — zero cross-contamination
- Cleaning validation with AI — dynamic MACO and continuous swab/rinse, without a bottleneck at every changeover.
- Clinical trial supply with AI — a site with no kit is a patient lost.
- Coder and serializer stitched to the ERP — zero serial mix-ups
- Combination products with AI — two regulatory worlds, one line, no gap in between.
- Early human verification with a 21 CFR Part 11 signature at the line
- EBR with AI — the batch ships in hours because QA only sees what departs from what was approved.
- From the delivery note and the CoA to the ERP with a single photo — 50-70% fewer receiving licenses
- From the physical chemistry Excel to the LIMS and ERP with no transcription — 50-80% fewer QC licenses
- From the supplier’s email to the concrete action with no human latency
- Galenic formulation with AI — from bench to plant without losing the conversation along the way.
- Giving the qualified granulator’s panel life without requalifying the asset
- GMP biotech with AI environmental monitoring — particles, microbiology and bioreactor on a single platform.
- GMP validation with continuous AI evidence — IQ/OQ/PQ alive, with no sprints before every audit.
- Granulation and compression in oral solids with AI — real RTRT, not a slide deck for the audit.
- iLEAN in regulated industry — five compliance pillars by design
- LAL/rFC endotoxin testing with AI — faster parenteral release, a firmer dossier.
- mAb/ATMP bioreactor control — anticipate drift minute by minute and hold per-patient traceability.
- MDI inhaler control with AI — one gram of propellant out of range is one delivered dose out of range.
- OEE on a pharma line — better performance without breaking GMP validation.
- OOS and GMP deviations with AI — QA should not spend weeks looking for what is already in the system.
- OTC manufacturing with AI — the line runs too fast to watch. Edge watches it.
- Paperless batch startup: MBR and log book at second zero
- Pharma API weighing control with AI — one misplaced decimal is one lost batch.
- Pharma blister control with AI — the half-empty cavity that comes back as a patient complaint.
- Pharma Class I/II/III recall with AI — in a Class I every hour counts, and the downstream trail is never ready.
- Pharma FMD/DSCSA serialization with AI — one badly aggregated serial is a pallet held at the border.
- Pharma lyophilization with AI predictive control — a 48-hour cycle, and a deviation takes 5 minutes to destroy the batch.
- Pharma pure gas control with AI — the gas is not in the batch, but it decides the batch.
- Pharma QC glassware control with AI — lose the lineage of the vial and you lose the batch.
- Pharma traceability from API to patient — one pharmacovigilance alert and you have 24 hours to rebuild the full genealogy.
- Pharmaceutical capsule filling with AI — the dose drifts before blistering, not after.
- Pharmaceutical dispensing with AI — one badly signed weighing costs the whole batch.
- Pharmaceutical topical cream manufacturing with AI — the emulsion does not break during packing, it breaks on the previous shift.
- Prefilled syringe inspection with AI — every unit leaves with its own file, not just its batch number.
- Protein purification with AI — chromatography curve drift shows up before the peak, not after the batch.
- Radiopharmacy with AI — short half-life, no margin to rebuild the batch afterwards.
- Rapid microbiology with AI — release batches sooner without touching the reference method.
- Real AI cases in hormonal pharma
- Spray drying with AI — process drift shows up half an hour early, not after the batch.
- Subvisible particles in parenterals with AI — by the time you read it, the batch is already rejected.
- Syrup filling control with AI — one milliliter out of range is not an incident, it is an OOS deviation.
- Tablet coating with AI — the defect is not visible in the lab: it is visible in the pan.
- The blister defect ejected in line with Edge — 100% cavity control at real rate
- The IPT lead’s earpiece — operational knowledge enters the system in real time
- Transdermal patch control with AI — one micron of thickness out is one dose released out.
- Visual inspection of injectables with AI — the eye must not blink, and by the end of the shift it blinks.
- Zero critical deviations and batch release in days — 4 rings coordinated by Agents
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