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Automatic Screening Machine with Visual Inspection

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BONFIGLIOLI EENGINEERING
  • Application in ampoules, BFS, cartridges, vials and bottles;
  • Compatible with products: powder, lyophilized and liquid;
  • Speed up to 600 units/minute;
  • Full batch control testing: fast, reliable, and repeatable;
  • Non-invasive and non-destructive inspection capabilities;
  • Detection of the presence of foreign particulate matter, cosmetic defects, false fill level and product color;
  • Maximum accessibility of electrical and mechanical components for easy maintenance;
  • Computerized system in accordance with ISPE GAMP 5 guidelines and in compliance with FDA 21 CFR Part 11 and EU Annex 11.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BONFIGLIOLI TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Combined Screening with Leak Test, Visual Inspection and HGA

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BONFIGLIOLI EENGINEERING
  • Combined station for leak testing through pressure, visual inspection of particles and cosmetic defects and quantitative analysis of gases in the headspace;
  • Non-invasive and non-destructive inspection of various types of pharmaceutical packaging;
  • State-of-the-art measurement and control system;
  • Fully customizable to meet different demands of the production line;
  • Suitable for 100% in-line testing at high speed, without changing the container characteristic;
  • Fast, reliable and repeatable testing;
  • Management of statistics of critical process parameters;
  • Compliance with GMP, EU Annex 11 and 15 and FDA 21 CFR Part 11 requirements.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BONFIGLIOLI TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

In-Line Reviewer with Integrity and Leak Test

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BONFIGLIOLI EENGINEERING
  • Non-invasive and non-destructive integrity inspection based on vacuum and pressure drop method;
  • Micro leak detection inspection capability;
  • Compatible with products: semi-solid, powder, lyophilized and liquid;
  • Speed up to 600 units/minute;
  • Quick format change;
  • Automatic drying system, no contamination of the test chamber;
  • Statistical process control for deviation reduction and better yield control;
  • CFR 21 Part 11 compliance and full 4.0 integration.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BONFIGLIOLI TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.

Sample Bench Leak Test

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BONFIGLIOLI EENGINEERING
  • Non-destructive leak testing by sampling/small batches;
  • Application in vials, ampoules, BFS, FFS, vials, pre-filled syringes, cartridges, trays, bags, sachets, flowpacks, cups and other filled and sealed flexible and semi-flexible packaging;
  • Compatible with products: powder, lyophilized, liquid, paste, solids and semi-solid;
  • Test speed ranges from a few seconds to approximately 1 minute, depending on the size of the container;
  • Non-invasive and non-destructive inspection resource;
  • Vacuum and pressure drop test method;
  • Possibility of using different formats for a variety of containers;
  • Ergonomic design: lightweight, compact, easy to operate, clean and move;
  • FDA 21 CFR Part 11 and EMA Annex 11 compliant.

STEQ IS THE ONLY COMPANY IN BRAZIL AUTHORIZED AND CERTIFIED BY BONFIGLIOLI TO PROVIDE TECHNICAL SUPPORT AND SUPPLY ORIGINAL PARTS FOR THE ENTIRE LINE OF EQUIPMENT.