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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.

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Isolator Monitoring

AssayCore Micro · Aseptic fill isolators · EU GMP Annex 1 (2022) §4 · ISO 10648-2 · PDA TR 34

Isolators online

VHP cycles today

Pressure breaches

Integrity tests pass

1 isolator require attention

Leak rate 0.82%/h (max 0.5%/h)

EU GMP Annex 1 (2022) §4.30–§4.34: Isolators must maintain positive pressure differential ≥15 Pa. VHP decontamination: log-6 reduction of Geobacillus stearothermophilus BI per validated cycle. ISO 10648-2 Class 3: leak rate ≤ 0.5%/h. Pressure, leak rate and VHP parameters must be continuously recorded per §4.32.

Isolator ID	Designation	Status	Grade	Pressure (Pa)	Leak rate %/h	VHP (ppm)	VHP time (min)	Last integrity test
ILC-01	Isolator Filling Line A — Primary fill/finish	VHP Cycle	A	38.3	0.07	505	65	2026-04-18
ILC-02	Isolator Filling Line B — Vial filling unit 2	Maintenance	A	46.2	0.36	—	—	2026-04-11
ILC-03	Isolator Inspection — Cosmetic container check	Maintenance	B	25.3	0.82	—	—	2026-04-05
ILC-04	Isolator Weighing — Potent compound dispensing	Online	A	41.6	0.05	—	—	2026-04-10
ILC-05	Isolator QC Sampling — In-process testing	Online	B	52.5	0.29	—	—	2026-04-13
ILC-06	Isolator Maintenance Reserve — Standby unit	Online	C	30.5	0.31	—	—	2026-04-13