Quick and sensitive test Zero alteration of container features Vacuum and positive pressure testing Fast, reliable and repeatable results Highly functional, intuitive HMI Cost-effective solution System autodiagnostics available

Technical Features

• Container Application:Ampoules, Vials, Pouches, MDPI, MDI, IV Bags, Flowrapped Device, Flowpacks PFS, Carpoule, Bottles.
• Products: Filled, Empty, Closed
• Container Dimensions: From 5 x 30 x 5 mm (min) to 86 x 86 x 250 mm (max)
• Speed: Up to 20 cpm
• Technology: CCIT
• Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum Decay Method
• Inspection Capabilities: Microleaks detection

Additional Benefits

• Compact and robust design
• Maintenance-free
• Quick change over
• Low power consumption
• Storage, maintenance, and download of historical data (production, raw data, events, alarms)
• HMI Real Time display of Testing Cycle diagram
• Computerised system is designed to comply with FDA 21 CFR Part 11 and EU Annex 11
• Validation Package guarantees complete and efficient regulatory compliance

Technology

• Container Closure Integrity Testing is a non-destructive measurement technology based on Vacuum Decay Method
• Measurement system comprises applying a pressure differential into an airtight testing group enclosing the container.
• The test objective is to detect container leakages by measuring the reached pressure level as well as the pressure change over test time.

Quality Assurance

• Equipment test method refers to:
• Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
• FDA 21 CFR part 11 as well as EMA Annex 11
• The Machine Qualification and Validation complies with requirements stated in EU Annex 15