SAIL Smart Automated Inspection Laboratory

Pharmaceuticals

SAIL is an automated inspection laboratory for different container types, sizes, and contents bringing together CCIT, AVI and HGA all in one machine suitable for in-process, clinical trials and laboratory use.

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Ampoules

BFS

Carpoules

Cartridges

Prefilled Syringes

Vials

Tech specifications

Highlights

All in one Industry 4.0 based laboratory
Ergonomic workstation
Scientific and objective inspection
100% traceability
Time & cost saving

Technical Features

Container application: BFS, Vials, Ampoules, PFS, Cartridges, Carpoules
Products: Lyo, Liquid, Powder
Container Dimensions: Ø [10 - 69] mm
Speed: 50 - 500 cph (depending on configuration)
Technology: CCIT - AVI - HGA
Inspection Features: A COBOT optimizes the collaborative non-destructive inspection processes
Inspection Capabilities: Integrity testing; foreign matters, cosmetic and cap defects; Oxygen/Moisture/Carbon Dioxide level, Absolute Pressure value

Additional Benefits

Single operator
Single validation & qualification procedure
Multiple inspections, containers, formats
Easy & fast evaluation thanks to real time HD display
Automatic Container Handling
New user-friendly touchscreen HMI, Android-like,22” size adjustable panel
Tool-less, no format change by means of automatic adjustments and regulations

Technology

SAIL modular structure provides adequate flexibility upon all 3 of testing technologies:
- AVI (Automatic Visual Inspection)/ SAVI a collection of images is acquired using high resolution matrix cameras under designed illumination conditions.
- CCIT (Container Closure Integrity Testing) non-destructive integrity testing in packages by Vacuum Decay Method.
- HGA (Headspace Gas Analysis) inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which accurately quantifies gaseous concentration levels.

Quality Assurance

Software designed to comply with FDA 21 CFR Part 11 and EU Annex 11
Visual Testing method conforms to current pharmaceutical regulations, such as USP – United States Pharmacopeia - General Chapter <790> and European Pharmacopeia § 2.9.20
Vacuum decay Method based on the approved industry standard ASTM F2338-09, recognised by the FDA
HGA Testing method in conformity with provisions of USP General Chapter <1207>
The Machine Qualification and Validation complies with requirements stated in EU Annex 15
Machine manufacturing process and materials are compliant with applicable GMP requirements.