FulcrymSENTINEL
Automated pharmaceutical solid-dose inspection
● SIMULATION ONLY—
FULCRYM PRESENTS SENTINEL · INTERACTIVE DEMO
PHARMACEUTICAL INSPECTION, REIMAGINED
S E N T I N E L

Automated Tablet Inspection

Finds defective tablets and prepares the quality report.

01Inspect Tablets

Inspect sample tablets

02Detect Defects

Highlight quality findings

03Prepare QA Evidence

Document the inspection

315-tablet sampledemonstrated in seconds
DEMONSTRATION MODE · SIMULATED INSPECTION DATA · NOT A GMP RECORD

Machine Overview

SENTINEL 01 · Operator interface concept
● DEMO READY
Sample inspected
0 / 315
Illustrative inspection
Accepted units
0
All required checks passed
Flagged units
0
Queued for QA review
Nominal capacity
~100k
Tablets/hr design target · not measured here

Active inspection profile

ProductRound 10 mm · White
ProfileIP-DEMO-001 / Rev A
Sample plan315 units · Illustrative
Change partsNot verified

Machine & control boundary

GuardLogix PLCNOT CONNECTED
Vision stationsSIMULATED
Door interlocks / STONO LIVE INPUTS
Physical RUNRequired on production machine
This demonstration cannot energize motion, issue safety commands, or make a GMP batch-release decision.

Inspection Workflow

Guided operator sequence · illustrated electronic sampling
STEP 1 OF 4
01
Choose the tablet
Select a recipe, then continue.
1 · SETUP
2 · VERIFY PARTS
2.5 · QA PLAN
3 · INSPECT
4 · REVIEW

Select Product & Batch

Choose the tablet format and identify the inspection batch.

IP-DEMO-001 · Rev A ● Approved (simulation)

Batch & Recipe Details

WorkflowOff-line AQL sample inspection
Sample size315 units
Sampling locationsBeginning / middle / end
CriteriaPer approved customer QA profile
The initial 315 is an illustrative demonstration size, not a universal AQL requirement. Actual sample plans and acceptance numbers depend on the customer's approved method.

Verify Change Parts

Commercial direction: scan each installed part and compare part ID/revision against the selected recipe. For today's demo, tap each simulated scan.

Controlled format changeover

10
P
C
Required recipeRound 10 mm · White
Confirmation methodQR / Data Matrix concept
TraceabilityIDs + revisions + operator/time
The tablet camera isn't reading physical codes in this preview. These are demonstration confirmations, not verified installed parts.

Set QA Sampling Plan

Wahid, classify example defects and set the customer's proposed sampling parameters. These choices require authorized QA approval in a real system.
Lot size (tablets)
General inspection level
Sampling regimeNormal · Single
Major defect AQL
Minor defect AQL

Classify illustrative defects

Edge chip
Surface discoloration

Calculated sampling preview

Code letter
M
Base sample n
315
Major acceptance / rejectionAc 7 / Re 8
Minor acceptance / rejectionAc 14 / Re 15
Illustrative finding classes1 major · 1 minor
✓ Example table entries cross-checked

Code M, normal single sampling, Level II. Verify the applicable controlled table and customer-approved procedure before operational use.

Important: Defect classification selects the applicable AQL criteria; it does not itself set the base sample size. For some AQL/code combinations, ANSI/ASQ Z1.4 table-arrow rules change the final required n. Critical defects need separate customer QA criteria. Never treat the preview as a validated GMP sampling plan.
Reference: ANSI/ASQ Z1.4, Table I and Table II-A. Demonstration helper only; full licensed table implementation is not included.

Sample inspection

BatchDEMO-WAHID-001
Sample progress0 / 315
Accepted
0
Flagged
0
Rate
0
simulated/hr

Multi-view inspection concept

1
2
3
4
Vision heads4 multi-view inspection stations
ClassificationEmpty / foreign / reject / accept
Decision policyFail closed · accept only if all checks pass
Physical run commandNot available on tablet

Animation and statistics are illustrative only; no images were acquired, no defects detected, and no PLC command issued.

Sample review

Inspected
315
Accepted
313
Flagged
2
Flagged: DEMO-0147Edge chip · review
Flagged: DEMO-0281Surface discoloration · review
Machine classifications and sample acceptance decisions are separate. No batch release is determined here. Customer QA reviews the output under its approved plan.

Example flagged-unit evidence

147
DEMO-0147 · Edge anomaly
Simulated classification · Camera evidence placeholder · QA review needed
281
DEMO-0281 · Surface anomaly
Simulated classification · Camera evidence placeholder · QA review needed

In commercial Sentinel, image evidence would be linked to specific sample IDs, capture metadata, profile revisions, users, and timestamps.

Products & Recipes

Representative solid-dose formats · controlled recipe concept
3 DEMO FORMATS

Commercial recipe controls

Product master & revisionControlled
Vision configuration & calibrationValidated machine method
Format/change-part associationIdentity + revision check
Approved inspection profileCustomer QA approval required

Quality / AQL

Approved Inspection Profile — illustrative QA-owned specification
IP-DEMO-001 · REV A

Approved Inspection Profile

Profile revisionIP-DEMO-001 / A
StatusAPPROVED · DEMO
SamplingBeginning / middle / end
Illustrative sample315
Defect classesCritical / major / minor
QA responsibilityPlan, criteria, approval, disposition
Approved profiles are immutable in the intended commercial design. Changes create a new controlled revision; demonstration profile here has no real approval.

Responsibility boundary

Customer QualitySpecifications + final batch decision
Fulcrym systemRepeatable inspection execution
Evidence serviceCounts, images, events, reports
Acceptance numbersDefined by customer-approved plan

Sample counts, threshold values, and depicted defects do not demonstrate sensitivity, specificity, or validation.

Batch Records & Evidence

Electronic inspection package concept · illustrative data only
BatchFormatSampleFlaggedProfileStatus
DEMO-WAHID-001Round 10 mm315—IP-DEMO-001/AQA review required
DEMO-1020-BOblong caplet3150IP-DEMO-002/AExample closed

Example evidence manifest

Batch + recipe revisionLINKED
Profile / sample locationLINKED
Individual sample decisionsSIMULATED
Inspection imagesPLACEHOLDERS ONLY
Electronic signatureNOT IMPLEMENTED

QA disposition

Batch disposition is intentionally NOT simulated as an automatic release. Customer QA owns investigation, review, and approval.
PENDING QA REVIEW

This is a sales demonstration, not a validated or Part 11-compliant electronic batch record.

Diagnostics / Service

Restricted engineering functions concept
NO HARDWARE ACCESS

Machine communications

Galaxy Tab HMIDEMO DISPLAY ACTIVE
Advantech UNO servicesNOT CONNECTED
GuardLogix / CIPNOT CONNECTED
Kinetix 5300 servoNOT CONNECTED
Basler camerasSIMULATED
Safety interlocksNO LIVE STATUS

Production architecture guardrails

Operator and service privileges must be distinct. The local HMI may request approved operations but cannot replace hardwired emergency stops, PLC permissives, safety-rated interlocks, or the physical RUN control.

For the Wahid demonstration, all sensor values, defects, motion, classifications, and communications are local simulation only.
● DEMONSTRATION COMPLETE

THE SAMPLE IS READY FOR QA REVIEW

Tablets inspected
315
Example findings
2
Evidence state
PREPARED

Sentinel records the inspection and makes the results available to customer QA. The customer determines final sample acceptance and batch disposition under its approved procedure.

Simulated data · Not a GMP record · No validated product performance represented
FULCRYM SENTINEL · CEO DEMONSTRATION
SENTINEL v0.8.8 · BUILD 20261021