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Compliance
ISO 15189ISO 11133ISO 11737EUCAST v16.0CLSI M100-S34EU GMP Annex 1USP <71>

Interactive marketing demo running on Vercel with mock data. Click any feature to explore — no account needed.

Production stack for AssayCore Micro

Core: PostgreSQL 16 + Redis 7 + Kafka 3.7 + MinIO + Keycloak 24 + Spring Boot 3.3 (Kotlin) + React 18/MUI + FastAPI ML (Python 3.11) + Nginx + Docker

Module-specific: PyTorch 2.x + YOLOv8 + OpenCV colony AI · EUCAST v16 / CLSI M100-S34 AST breakpoints · AMR expert rules (EUCAST v3.4) · VITEK/MALDI-TOF/ASTM bridges · EM trending dashboard with alert/action limits (EU GMP Annex 1)

Deployable on your infrastructure or our managed Hetzner. Self-hosted source-license available.

Endotoxin (LAL)

Bacterial endotoxins test · USP <85> / Ph.Eur. 2.6.14 / JP XVIII 4.05 · 36 tests · 3 OOS

Tests today

4

Passes

32

Out-of-spec

3

Std curve r² median

0.991

Acceptance criteria

Gel-clot endpoint: No gel formation in both replicates at the dilution ≤ MVD = (Endotoxin Limit × Concentration) / λ.

Kinetic methods:PPC spike recovery 50–200%; standard curve r² ≥ 0.98; inhibition/enhancement confirmed absent per USP <85>.

Endotoxin limit (IV human): L = K/M where K = 5 EU/kg/h; M = max dose in mL/kg/h. Ph.Eur. 2.6.14 Sec 3.

Test IDSampleProductCSE lotDilutionλ (EU/mL)Limit (EU/mL)MVDRep ARep BResultAnalystDate
LAL-GC-001SMP-04000Injectable WFI (bulk)L142851:40.1250.258PASSElena Roth2026-06-08
LAL-GC-002SMP-04001Parenteral nutrition solutionL142851:20.030.053PASSYuki Tanaka2026-06-12
LAL-GC-003SMP-04002IV antibiotic — ceftriaxoneL142801:40.1250.052PASSYuki Tanaka2026-06-14
LAL-GC-004SMP-04003Sterile saline 0.9%L142761:20.250.252FAILElena Roth2026-06-17
LAL-GC-005SMP-04004Ophthalmic drops (sterile)L142801:20.250.54PASSYuki Tanaka2026-06-10
LAL-GC-006SMP-04005Heparin sodium injectionL142771:20.030.053PASSCarlos Vega2026-06-11
LAL-GC-007SMP-04006Albumin 20% solutionL142771:160.060.5133PASSCarlos Vega2026-06-09
LAL-GC-008SMP-04007Glucose 5% infusionL142801:160.060.127PASSElena Roth2026-06-15
LAL-GC-009SMP-04008Ringer lactate solutionL142801:160.060.2567PASSElena Roth2026-06-12
LAL-GC-010SMP-04009Epinephrine injectionL142771:20.250.252INVALIDCarlos Vega2026-06-17
LAL-GC-011SMP-04010Insulin lispro injectionL142771:160.1250.564PASSElena Roth2026-06-08
LAL-GC-012SMP-04011Vancomycin IVL142851:40.250.58PASSYuki Tanaka2026-06-12