Product Description
A complete range of products that covers all nominal production throughput/speed of production lines. Each Machine is designed for Non-Invasive, Non-Destructive Integrity Testing of diverse types of Pharmaceutical Containers and Contents. It is conceived for 100 % in-line testing at high production speed. Testing is fast, reliable and repeatable, giving consistent results and allowing for full batch control without altering the container or content features.
Vacuum Decay or Pressure Decay Methods allow to reach full compliance with current cGMP international regulations.
High class mechanical design and automation solutions fit for the purpose to perform, ease service and avoid downtime.
Equipment has full capability to be integrated into Industry 4.0 environment with Electronic Batch Record management or Manufacturing Execution Systems.
Main Features and Benefits
- High inspection solutions flexibility
- High stability of application system and validation principles
- Hardware and Software optimization according to customer URS
- AVI no limited visual defects detection
- CFR part 11 compliance and 4.0 full integration
- Computer-based automated measurement system: image acquisition, processing, and decision making.
- High resolution cameras coupled with illuminators automatically positioned so to magnify regions of interest and designed according to defect type.
- Maximum accessibility of electrical and mechanical component for easy maintenance.
- Connections to Active Directory and VPN router for machine remote access.
- Validation package guarantees complete and efficient regulatory compliance.
- 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
- Real time display of statistical raw data
- Easy, quick and safe remote access
- Easy cleaning
