THE ARCHITECTURAL DIFFERENTIATOR

Air-Gapped On-Premise AI for Regulated Operations

We deploy open-weight foundation models directly onto dedicated GPU silicon inside your physical facility walls. Zero external API calls, zero per-token metered costs, and zero exposure to the public internet.

SYSTEM BLUEPRINT

The On-Premise Reference Architecture

An end-to-end blueprint illustrating how document ingestion, local inference runtimes, dual-NIC network segregation, and human-in-the-loop governance operate in complete physical isolation.

AIR-GAPPED ON-PREMISE REFERENCE ARCHITECTURE

Client Physical Perimeter • Zero Internet Exposure • 21 CFR Part 11 Validated

[X] CLOUD EGRESS: BLOCKED
CLIENT FACILITY PHYSICAL PERIMETER & SERVER ROOMPUBLIC INTERNET [NO EGRESS]01. INGESTION & DOCUMENT STOREProprietary PDF Archives• SOPs, CoAs, Batch Records• Regulatory Filings & ContractsMulti-Scale Local OCR Engine• 300 DPI Local Vision Models• Spatial Coordinate Extraction• Tabular Geometry ReconstructionHybrid Storage on Local NVMe• Sparse: BM25 for Exact SKUs / Codes• Dense: Fine-Tuned Domain Vectors• Local Cross-Encoder Re-Ranking✓ Zero Data EgressERP / MES / LIMS Connectors• Read-Only Parameterized SQL• Replica Gateways (SAP / Oracle)• Role-Based Access Control• Normalized Schema Extraction02. ON-PREMISE GPU INFERENCE SILICONDedicated Server Hardware (Tier 2)4x NVIDIA RTX 6000 Ada (192GB VRAM)Dual AMD EPYC 9354 • 512GB ECC DDR5Physical Dual NIC (Zero Default Gateway)Latency: 240ms TTFT • 52 tok/s per stream✓ 100% Offline ResilienceOpen-Weight Models (FP8 / INT4 AWQ)Llama 3.3 70B • Qwen 2.5 72B • DeepSeek• vLLM / TensorRT-LLM Continuous Batch• Deterministic Greedy Sampling (GxP)• Cryptographic SHA-256 Tensor Pinning• Telemetry Nullified in Source Build• 64,000 Token Extended Context Window21 CFR Part 11 Audit Trail Ledger• Immutable Cryptographic Append-Only• High-Resolution Digital Timestamps• Exact User Attribution & Role Signatures• Local Encrypted NVMe Storage✓ Regulatory Inspection Ready03. AGENTIC EXECUTIONSpecialized Domain Agents• Vendor Qualification Agent• CoA & Specification Matcher• Deviation & CAPA Drafting Agent• Price Variance & Contract Agent• Regulatory Dossier Prep Agent• Ephemeral Linux Sandbox ExecutionDeterministic Citations• Token: [DocID : Page : Bounds]• Split-Screen Source Highlighting• Ungrounded Claims Blocked• Instant Auditor Inspection✓ 100% Provenance GuaranteeHuman-in-the-Loop Sign-Off• Quality / Procurement Officer• Zero Autonomous Spending• 90-Second Evidence Verification• Cryptographic Commit to ERP✓ Verified ERP Execution
SILICON SELECTION

Dedicated Hardware Sizing Tiers

We size and procure turnkey hardware optimized for your exact document throughput and agent concurrency targets.

HARDWARE SIZING SPECIFICATIONS

Turnkey Hardware Tiers for On-Site Inference

Owned Silicon • Zero Token Rent
TIER 01Acoustically Treated Tower

Departmental Pilot Workstation

Facility pilot validations, clinical R&D teams, legal contract audits, and single-batch deviation investigations.

GPU Acceleration / VRAM2x NVIDIA RTX 6000 Ada (96GB VRAM)
Host CPU & RAMAMD Threadripper 7965WX • 256GB ECC RAM
Local NVMe Storage2x 3.84TB Enterprise NVMe (RAID 1)
Throughput & ConcurrencyUp to 8 concurrent streams • 35 tok/s
Power & Thermal Requirements1,200W (Standard 120V/220V Outlet)
✓ Air-Gap Ready21 CFR §11
STANDARD PRODUCTION DEPLOY
TIER 024U Rackmount Server (Standard 19")

Full Facility Inference Server

Site-wide operations, continuous ingestion of 50,000+ SOPs, multi-agent procurement swarms, and 24/7 GxP compliance.

GPU Acceleration / VRAM4x NVIDIA RTX 6000 Ada (192GB VRAM)
Host CPU & RAMDual AMD EPYC 9354 (64 cores) • 512GB ECC
Local NVMe Storage4x 7.68TB Enterprise U.2 NVMe (RAID 10)
Throughput & ConcurrencyUp to 32 concurrent streams • 110 tok/s
Power & Thermal Requirements2x 2,000W Redundant (Dedicated 20A circuit)
✓ Air-Gap Ready21 CFR §11
TIER 03Full 42U Datacenter Rack with InfiniBand

Enterprise Multi-Facility Cluster

Multinational manufacturing networks, multi-facility document consolidation, offline fine-tuning, and high-throughput ingestion.

GPU Acceleration / VRAM8x a 16x NVIDIA H100 / H200 (640GB–2.2TB)
Host CPU & RAMMulti-Socket EPYC Cluster • 1TB–2TB ECC
Local NVMe Storage30TB+ NVMe All-Flash Distribuido
Throughput & Concurrency120+ concurrent streams • 450+ tok/s
Power & Thermal Requirements6kW to 12kW (3-Phase PDU Distribution)
✓ Air-Gap Ready21 CFR §11
TOTAL COST OF OWNERSHIP MODEL

Compare Cloud Token Rent vs. Owned Silicon

Adjust the planning assumptions for an illustrative 36-month comparison. This is not a hardware quote or a cloud-vendor commitment.

Editable assumptions
Cloud / 36 months
$19,958
$554 / month
On-prem / 36 months
$91,210
4× RTX 6000 Ada · 2.2 kW
Modeled 36-month premium
$71,251
Estimated breakeven: 123 months
Modeled tokens / month123,200,000
Modeled energy / month$225
Tier capacity32 streams
Concurrency recommendationTier 2 · Enterprise 4U Server

Assumptions: 770 combined input/output tokens per page, 24/7 operation, electricity and support included for owned hardware. Labor, taxes, financing, additional cooling, backup storage, and vendor price changes are excluded.

COMMISSIONING PROTOCOL

Anatomy of an Air-Gapped Installation

A disciplined, step-by-step engineering protocol designed to guarantee that zero physical or logical data egress paths exist.

STEP 01

Bare-Metal Hardware Racking & Burn-In

Physical verification of supply chain provenance, UEFI/BIOS firmware integrity audits, 19" rack installation, 72-hour sustained GPU burn-in testing, and redundant power circuit validation.

Mandatory Validation Gate
STEP 02

Kernel-Level Network Isolation & Gateway Nullification

Physical dual-NIC segregation: NIC 0 binds strictly to local NVMe storage networks; NIC 1 exposes authenticated internal mTLS endpoints for authorized enterprise clients. Zero default gateway is configured.

Mandatory Validation Gate
STEP 03

Model Quantization & SHA-256 Tensor Pinning

Local FP8 / INT4 AWQ quantization of open-weight checkpoints. Cryptographic SHA-256 hashes are computed for every tensor file and pinned to an immutable boot manifest to prevent unauthorized weight tampering.

Mandatory Validation Gate
STEP 04

Zero-Telemetry Inference Engine Build

Inference runtimes (vLLM / TensorRT-LLM) are compiled directly from audited source trees with all Hugging Face hub pings, telemetry callbacks, and diagnostic beacons permanently compiled out.

Mandatory Validation Gate
STEP 05

Local Vector DB Bootstrapping & PDF Ingestion

Local vector engine bootstrapping on high-speed NVMe U.2 storage arrays. Ingestion workers process historical PDF archives, generating spatial bounding-box coordinates and tabular matrices.

Mandatory Validation Gate
STEP 06

21 CFR Part 11 Audit Trail Validation & Staff Handover

Execution of formal IQ/OQ/PQ protocols, validation of append-only cryptographic audit logs, disaster recovery rehearsal (recovery time objective < 4h), and operational handover to internal engineering.

Mandatory Validation Gate
FIELD VALIDATION

Production Regulated Deployments

Real-world implementations where on-premise agent swarms deliver measurable operational and regulatory gains.

Pharmaceutical Manufacturing[PROD-01]

Automated Batch Deviation & CAPA Drafting

OPERATIONAL BOTTLENECK

A sterile injectable manufacturer faced 14-day cycle times investigating batch deviations, requiring operators to manually cross-reference process logs against 4,500 active SOP revisions.

DEPLOYED ARCHITECTURE

Tier 2 Server (4x RTX 6000 Ada) • Llama 3.3 70B (FP8) • 50k SOP library vector index • Split-screen bounding box viewer.

MEASURABLE OUTCOME

Investigation turnaround collapsed from 14 days to 4 hours. Zero compliance findings during FDA inspection due to deterministic page coordinate citations.

Chemical Supply Chain[PROD-02]

Air-Gapped Supplier & CoA Reconciliation Swarm

OPERATIONAL BOTTLENECK

Procurement specialists were approving chemical raw material requisitions under immense time pressure without systematically checking trace impurity limits against pharmacopeia monographs.

DEPLOYED ARCHITECTURE

3-agent specialized swarm • Parameterized read-only SAP ERP connector • CoA tabular geometry parser • Human cryptographic commit gate.

MEASURABLE OUTCOME

Identified 3 out-of-spec impurity variances prior to purchase order commitment, preventing $280,000 in batch contamination and material scrap.

Clinical Hospital Operations[PROD-03]

On-Premise Clinical Pathology & Chart Extraction

OPERATIONAL BOTTLENECK

A hospital network held 300,000+ unstructured clinical charts and pathology reports in scanned PDF format, legally prohibited by patient data privacy laws from using public cloud OCR.

DEPLOYED ARCHITECTURE

Tier 1 Workstation • Qwen 2.5 72B INT4 AWQ • Local 300 DPI pathology-optimized OCR • Hospital isolated intranet.

MEASURABLE OUTCOME

Complete retrospective digitization completed in 3 weeks with 100% data residency maintained inside hospital data center.

Food & CPG Manufacturing[PROD-04]

Allergen Verification & Recipe Lineage Audit

OPERATIONAL BOTTLENECK

Shared high-speed packaging lines required continuous verification of clean-in-place (CIP) logs and allergen declarations to prevent multi-million-dollar product recalls under FSMA.

DEPLOYED ARCHITECTURE

Tier 2 Server • Local DeepSeek reasoning engine • Plant MES integration • Immutable local verification journal.

MEASURABLE OUTCOME

Real-time automated line-clearance audit in under 60 seconds per changeover, achieving 100% allergen labeling compliance.

Request a Hardware Sizing Specification

Share your monthly document ingestion volume and active ERP platforms. We will deliver a customized silicon sizing and 3-year TCO comparison.