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Contamination Control Strategy (CCS) • Cleanroom Spatial Floor Plans • 21 CFR Part 11
Traditional environmental monitoring software isolates cleanroom microbiology in disconnected data silos, forcing quality teams to manually cross-reference paper settle plate logs and CSV files before releasing commercial drug products. Novaqis LIMS operationalizes the revised EU GMP Annex 1 (2022/2023) mandate directly within your core QC data fabric: dynamic CAD/SVG cleanroom zoning across Grade A–D suites, automated 4-hour settle plate desiccation countdown timers, validated dual-stage incubation chains (20–25°C fungal followed by 30–35°C bacterial), automated USP <1116> Contamination Recovery Rate (CRR) calculations, and immediate fail-closed quarantine locks halting Qualified Person (QP) batch disposition upon active cleanroom excursions.
Product preview
Interactive coordinate pins across Grade A–D filling lines with real-time excursion statuses
LIMS / Lab Dashboard
Laboratory Testing & Sample Workload Hub
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Upload validated cleanroom architectural schematics and define Grade A unidirectional airflow zones, Grade B preparation rooms, Grade C airlocks, and Grade D corridors. Technicians execute guided sampling tours on mobile tablets with real-time coordinate pins for active air, continuous settle plates, contact RODACs, surface swabs, and operator 5-finger glove prints.
Annex 1 Clauses 9.22 & 9.24 strictly limit agar settle plate exposure to 4 hours to prevent media dry-out. Novaqis activates digital countdown timers the moment a plate is uncapped, alerts operators before desiccation occurs, and locks plate accessioning if media lots lack verified Growth Promotion Test (GPT) certificates.
Clause 9.30 requires validated incubation to recover both slow-growing environmental fungi and fast-growing bacteria. Novaqis sequences the dual incubation regimen automatically: 20–25°C for 72–120 hours, followed by automated incubator transfer notifications to 30–35°C for 48–72 hours, preventing premature enumeration.
Replaces deceptive CFU averages in low-contamination environments with true statistical incident rates: CRR (%) = (Samples >0 CFU / Total Samples) × 100. Evaluates rolling 30/60/90-day contamination trends against Grade A (<1%), Grade B (<3%), Grade C (<5%), and Grade D (<10%) limits.
Bridges laboratory microbiology directly to manufacturing execution. If a non-zero count is logged in a Grade A filling suite or an unresolved microbial alert exists in adjacent airlocks, Novaqis BRM immediately locks the Qualified Person (QP) batch release gate with fail-closed cryptographic security.
Seamless accessioning for isolate identification via MALDI-TOF mass spectrometry or VITEK 2 systems. Tracks genus, species, gram stain, spore-forming traits, and cleanroom bioburden flora history for regulatory audit defense.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Dynamic CAD/SVG cleanroom zoning across Grade A, B, C, D suites with coordinate sampling pins, visual excursion heatmaps, and continuous airflow direction alignment.
Automated 4-hour (240-minute) desiccation timers, barcode-verified plate placement, and growth promotion test (GPT) media lot verification gates.
Automated dual-stage incubation chain (20–25°C fungal for 72–120 hrs, then 30–35°C bacterial for 48–72 hrs) with programmatic plate reading screen lockouts until required durations elapse.
Mathematical CRR % calculation across rolling 30/60/90-day intervals, tracking incident rates per cleanroom zone without distortion from isolated statistical outliers.
Immediate fail-closed quarantine of manufacturing batches in Novaqis BRM if an Action Excursion occurs in active filling suites or critical Grade A aseptic zones.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Zero uninvestigated cleanroom excursions bypassing Qualified Person (QP) batch disposition
Eliminated dual-system validation overhead and fragile CSV imports between LIMS and standalone EM point tools
100% adherence to 4-hour settle plate exposure limits and validated dual-temperature incubation chains
Live, inspection-ready Contamination Control Strategy (CCS) trending across Grade A–D cleanroom suites
Up to 68% lower 5-year TCO compared to standalone EM software (Lonza MODA-EM / Novatek) with $0 per-seat licensing
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