- Improved functionality of the testing chamber group
- Multiple format, content type and sizes machine
- Container application: Ampoules, Vials, Bottles (glass + plastic), Cartridges, Blow Fill Seal, Syringes, Injection Devices, Flowpacks, Pouches, and Testing Using Pucks
- High quality handling system, comprising State of the art electronic actuators and motor inverters
- Optimal testing results are achieved at nominal speed and also in case of speed reductions and increases
- High machine installation flexibility, by means of rotating tables or other systems like tray loading
- The network connection allows machine database production data exchange and download, also remotely, to the Line/Laboratory Supervisor for data management and control
- Production, test and alarms reports are printable either local or network printer
- Statistical Process Control is conceived to give full support to the quality system, maintenance and process control staff
- PLC manages all Machine actuation commands and D.C.U. manages Leak Testing Data elaboration
- Automatic head exclusion allows any testing chamber to be excluded from the leak testing process
- Equipment test method complies with:
- FDA Guidance for Industry “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”
- United States Pharmacopoeia General Chapter «1207» “Packaging Integrity Evaluation”
- EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
- PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
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