
SAIL – Smart Automated Inspection Laboratory
SAIL is a fully automated inspection system that integrates three advanced testing technologies—CCIT, AVI, and HGA—into a single platform. It is designed for seamless in-process, clinical trial, and laboratory use across various container types and formats.
Key Highlights
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Integrated All‑in‑One System: Combines Container Closure Integrity Testing (CCIT), Automated Visual Inspection (AVI), and Headspace Gas Analysis (HGA) in one Industry 4.0 compliant station.
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High Throughput: Capable of inspecting 50–500 containers per hour depending on configuration.
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Ergonomic Design: User-friendly workstation with automated container handling and minimal operator effort.
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Full Traceability and Objective Inspection: Ensures 100 % auditability with real-time evaluation via HD display.
Technical Specifications
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Supported Containers: Blow‑Fill‑Seal units (BFS), vials, ampoules, pre-filled syringes, cartridges, and carpoules.
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Product Types: Lyophilized powders, liquids, and powders.
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Container Size Range: Diameters from approximately 10 to 69 mm.
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Speed: 50–500 units per hour (configurable).
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Technologies Incorporated:
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CCIT via vacuum decay for detecting leaks,
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AVI with high-resolution cameras under controlled lighting to identify cosmetic, foreign matter, or cap defects,
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HGA using Tunable Diode Laser Absorption Spectroscopy (TDLAS) for gas-level analysis.
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Inspection Capabilities: Detects seal integrity issues, particulate contamination, surface defects, and measures headspace conditions including O₂, CO₂, moisture and pressure.
Additional Benefits
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Single Operator Workflow: Fully automated loading, inspection, and ejection.
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Tool‑less Format Changes: Automatic mechanical adjustments without manual format tooling.
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Unified Validation & Qualification: One standardized protocol covers all inspection modalities.
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Intuitive Touchscreen HMI: Android‑style interface on an adjustable 22″ HD panel with dynamic data display.
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Real-Time Feedback: Instant evaluation with advanced alerting and optimized decision-making.
Technology & Compliance
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Built to perform CCIT + AVI + HGA in one streamlined module.
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AVI method supports standardized visual defect detection and traceability.
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CCIT employs industry-standard Vacuum Decay testing for container integrity.
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HGA is based on precision laser absorption spectroscopy for accurate gas quantification.
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Software includes full compliance with FDA 21 CFR Part 11, EU Annex 11, and EU Annex 15 qualification protocols.
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Supports pharmacopeia-aligned validation standards such as USP <790> (AVI), ASTM F2338 (CCIT), and USP <1207> (HGA).
Why Choose SAIL?
✅ Comprehensive Inspection in One Unit: Eliminates the need for separate CCIT, AVI, and HGA systems—simplifying workflow and footprint.
✅ High-Speed, High-Precision Testing: Suitable for production lines needing rapid and reliable multi-point quality control.
✅ Minimal Operator Input: Automated handling and intuitive interface reduce manual intervention.
✅ Consistent Compliance: Built-in validation frameworks and audit-ready documentation streamline regulatory alignment.
✅ Flexible & Adaptable: Supports multiple containers, formats, and test methods with tool‑less changeover and modular design.
✅ Audit-Ready Traceability: Real-time HD display and traceable results ensure full batch control and quality assurance.
SAIL delivers an unparalleled combination of leak testing, visual inspection, and headspace analysis in one compact, connected, and compliant system—ideal for modern pharmaceutical QC, R&D labs, and clinical trial workflows.
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