DEMO MODE· Read-only demo with synthetic dataLearn more on assaycore.pro
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.

Sampling plan

Risk-based environmental monitoring · EU GMP Annex 1 (2022) Sec 9 · 32 sampling points · 30 active routes

Grade A points

7

Grade B points

8

Grade C points

12

Grade D points

5

Active routes

30

Action limit exceedances — 5 points require investigation

Buffer Prep Room 1Grade B6 cfu/swab > action 5
Clean Corridor SouthGrade C106 cfu/m³ > action 100
Media Prep LabGrade C115 cfu/m³ > action 100
Incubation Room 1Grade C26 cfu/swab > action 25
Material AirlockGrade D207 cfu/m³ > action 200

EU GMP Annex 1 (2022) — Grade action limits

GradeActive air (cfu/m³)Settle plate (cfu/4h)Contact plate (cfu/plate)Glove (cfu/5-finger)
Grade A≤ 1≤ 1≤ 1≤ 1
Grade B≤ 10≤ 5≤ 5≤ 5
Grade C≤ 100≤ 50≤ 25n/a
Grade D≤ 200≤ 100≤ 50n/a

Source: EU GMP Annex 1 (2022) rev. Table 9.1. Alert limits = 50–70% of action limits (site-specific).

Point IDGradeRoom / zoneSample typeFrequencyAlert limitAction limitLast resultRiskStatus
Grade AFilling Suite AActive airevery-shift1 cfu/m³1 cfu/m³1
active
Grade AFilling Suite ASettle plate (90mm 4h)every-shift1 cfu/4h1 cfu/4h1
active
Grade AFilling Suite AContact plate (55mm)every-shift1 cfu/plate1 cfu/plate0
active
Grade AFilling Suite AActive airevery-shift1 cfu/m³1 cfu/m³0
active
Grade AFilling Suite AGlove 5-fingerevery-shift1 cfu/glove1 cfu/glove0
active
Grade ASterility Test SuiteActive airevery-shift1 cfu/m³1 cfu/m³0
active
Grade ASterility Test SuiteSettle plate (90mm 4h)every-shift1 cfu/4h1 cfu/4h1
active
Grade BGrade B Ante-room WActive airdaily5 cfu/m³10 cfu/m³4
active
Grade BGrade B Ante-room WSettle plate (90mm 4h)daily3 cfu/4h5 cfu/4h3
suspended
Grade BGrade B Ante-room WContact plate (55mm)daily3 cfu/plate5 cfu/plate1
active
Grade BGrade B Ante-room EActive airdaily5 cfu/m³10 cfu/m³4
active
Grade BGrade B Ante-room ESettle plate (90mm 4h)daily3 cfu/4h5 cfu/4h4
active
Grade BBuffer Prep Room 1Active airdaily5 cfu/m³10 cfu/m³7
active
Grade BBuffer Prep Room 1Contact plate (55mm)daily3 cfu/plate5 cfu/plate1
active
Grade BBuffer Prep Room 1Surface swabdaily3 cfu/swab5 cfu/swab6
under-review
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