Quick and sensitive test Compact & maintenance free 3 configurations: BASIC, XL, SY Vacuum and positive pressure testing Applicable to any type of pharmaceutical containers Solutions in place for PFS, LVP, cartridges

Technical Features

• Container Application: Vials, PFS, Pouches, Strip Packs, Strip, BFS, Cartridges, Ampoules, Carpoules, PFS Nest, Flowpack, Bottles, Filled Pharmaceutical Monobloc Areosol Can, FFS, other Medical devices
• Products: Lyo, Liquid, Powder, Solid, Semi-solid
• Container Dimensions: Up to 1000 ml
• Testing time: From a few seconds to about 1 minute according to container size
• Technology: CCIT
• Inspection Features: Non-Invasive, Non-Destructive CCIT based on Vacuum & Pressure Decay Method

Additional Benefits

• Quick format change over
• Automatic plunger stopping device for PFS
• Auto-diagnostics verifies optimal working condition of the testing chamber and enables machine start-up
• Easy, quick and safe remote access
• Highly functional, intuitive HMI
• Real time display of testing cycle diagrams, statistical raw data
• Storage of records: maintenance, production, alarms

Technology

• Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
• Vacuum Decay Method
• Pressure 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.
• Lid deflection technology can also be implemented to detect leaks on foils of cups or pouches together with Vacuum Decay method.

Quality Assurance

• Equipment test method refers to:
• FDA 21 CFR part 11 as well as EMA Annex 11
• 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”
• Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”