Autotest in real time Easy to validate CFR 21 part 11 compliance and 4.0 full integration Quick format changeover High installation flexibility

Technical Features

• Container Application:IV Bags, Flowpacks & Pouches
• Products: Semi-solid, Powder, Liquid
• Container Dimensions: 40 x 40 x 10 mm (min); 150 x 150 x 50 mm (max)
• Speed: Up to 180 Cpm
• Technology: CCIT
• Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum Decay Method
• Inspection Capabilities: Microleaks detection

Additional Benefits

• Full batch control testing: fast, reliable and repeatable
• Testing of all nominal production line speed
• MES (Manufacturing Execution System connection) allows remote machine data exchange & download
• Statistical Process Control reduces deviations for a better yield control
• Real time display of testing cycle diagrams, statistical raw data
• Easy, quick and safe remote access
• AHE (Automatic Head Exclusion)
• Easy cleaning

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”
• United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation”
• EU Guidelines to GMPMedicinal Products for Human and Veterinary Use –Annex 1 “Manufacture of Sterile Medicinal Products”
• PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
• FDA 21 CFR part 11 as well as EMA Annex 11