Packaging Inspection Solutions

COMBI Series


Product Description

Bonfiglioli Engineering Combi series puts Container Closure Integrity Testing, Visual Inspection and HGA all under one roof making it the ideal solution to ensure Quality and Safety of Parenteral Packages and verify:

– Presence of leaks
– Headspace gas content
– Existence of visible foreign materials

Based upon the Bonfiglioli Engineering state-of-the-art proprietary technologies, the Combi series is fully customizable in order to best meet customers’ needs and cover all nominal production line speeds. They are suitable for 100 % in-line testing at high production speeds without altering the container features. Testing is quick, reliable and repeatable, and gives consistent results for a comprehensive batch control.

Main Features and Benefits

  • Compact footprint with optimized floor space requirements
  • High flexibility in space allocation and the option of remote electrical cabinets
  • The machines may be integrated into Industry 4.0 environments and perform non-invasive, non-destructive inspection of diverse types of pharmaceutical containers
  • The machine needs only one operator and a single validation & qualification procedure
  • Versatility to achieve customizable solutions for flexible interfacing with downstream and upstream machines and elimination of intermediary conveying
  • Automatic ejection system can be set on a single “One for all” or a multiple “One for each” output
  • Test and Inspection results can be documented and stored together ensuring 100 % traceability
  • Total cost reduction thanks to ease of maintenance, faster format changeovers, lower energy consumption
  • All-in-one solutions for high integration feasibility of different modular inspection technology systems in connection with a wide choice of links to the up-stream and down-stream line flow
  • Headspace Gas Analysis (HGA): It is a non-destructive, non-invasive inspection method based upon the Tunable Diode Laser Absorpti on Spectroscopy (TDLAS) technology for measuring the headspace levels of gases
  • Container Closure Integrity Test (CCIT): it is a non-destructive measurement technology based on the testing methods of vacuum decay and pressure decay
  • Automatic Visual Inspection (AVI): it is an automated camera based measurement technology detecting visual defects
  • Equipment test methods 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”
  • ...Approved industry standard ”ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
  • ...United States Pharmacopeia, USP General Chapter : “Visible Particulates In Injections”
  • ...United States Pharmacopeia, USP General Chapter : “Visual Inspection of Injections”


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