Bonfiglioli Engineering S.r.l.

Bonfiglioli Engineering is the worldwide leader in Quality Control Solutions for all packaging requirements in Pharmaceutical, Metal Can & Aerosol, Food & Beverage and Plastic markets. Founded in 1974, Bonfiglioli Engineering has been able to combine its remarkable engineering expertise with original thinking and innovative technological developments to create superior Quality Control Solutions. Since 2012, the company has become member of TASI Group – uniquely focused on leak testing, measurement and inspection – re-establishing its leading role and strengthening its organization.

Market presence

With over 5000 installations around the world, Bonfiglioli Engineering serves a truly global customer base, making a dramatic impact on the efficiency and the safety of the packaging industry worldwide. Bonfiglioli Engineering global sales team is internationally based with Area Sales Managers working from around the globe, supported by an extensive distributor network. Every project is technically supported directly by the company’s highly skilled and qualified engineers that, offer prompt and reliable assistance throughout the entire equipment life cycle.

Technologies

Bonfiglioli Engineering offers a wide production range of laboratories as well as in-line machines with the aim of inspection , based on three complementary technologies: Container Closure Integrity Testing, Visual Inspection, and Headspace Gas Analysis:

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

Testing is quick, reliable, and repeatable and gives consistent results for a comprehensive batch control, always without altering the container features.

Visual Inspection (AVI): Thorough visual inspection is a mandatory practice for injectable manufacturers to guarantee both quality and patient safety, Bonfiglioli Engineering provides a range of solutions based on automated image acquisition, dedicated image processing algorithms and decision making software packages to inspect finished package or product to identify and reject:

• visible foreign matter contaminated units
• cosmetic effects that could potentially affect product quality
• Defective cap and container closure Integrity
• Unsatisfactory Fill level and product color

Leak Testing (CCIT): Bonfiglioli Engineering has strong expertise in a range of hi-tech leak testing technologies that include:

• Vacuum Decay Method (VDM) a non-destructive Container Closure Integrity (CCI) practice applicable to most pharmaceutical package systems in which CCI testing is performed while the package itself is held within hermetically sealed test chamber.
• Pressure Decay Method (PDM), the preferred CCI approach when dealing with oil-based products (high viscosity or density).
• Lid Deflection: analysis of differential position of successive container lid profile measurements to detect closure integrity in IV bags, pouches, blisters, etc.
• Force Decay: Analysis of the force level variation following container mechanical pressing that is effective across a broad range of hermetically form filled sealed container systems, such as plastic bottles, IV bags, etc.

Headspace Gas Analysis (HGA): HGA verification is a particularly effective solution for ensuring parenteral product stability and sterility maintenance. It detects any modification in the headspace pressure, moisture or oxygen level that may result in the degradation of the active drug, likewise in the reduction of drug potency and product shelf life.

Products

Bonfiglioli Engineering provides dedicated solutions in the markets of Pharmaceutical, Food & Beverage, Plastic, Metal Cans & Tubes, Chemicals & Personal Care, Aerosol and more, effectively meeting all industrial needs with state of the art technology. The range includes 100% non-destructive solutions such as Leak Detection, Visual Inspection and Headspace Gas Analysis, for laboratories as well as in-line applications. Strong in its solid and synergic internal organization, Bonfiglioli Engineering provides consulting support aimed to develop solutions that can fully meet customer requirements and expectations.

Products

• LF Series: bench-top and Off-line machine designed for Non-Destructive Integrity Testing of: Vials, Pre Filled Syringes, Pouches, PFS Nest, Monobloc, IV Bags, Flowrapped Device, FFS, Carpule, Bottles, BFS, Ampoules, Liquid Forms, MDPI, MDI.
• PK Series: a range of in-line and offline machines to perform VDM or PDM based closure integrity testing in vacuum/pressure test chamber.
• LVA 600: in-line fully automated test unit for performing Headspace Gas Analysis (HGA) on sterile pharmaceutical containers.
• COMBI Series: In-line Combined CCIT, HGA and Visual Inspection Automatic Machine. 3 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.
• RLD-400A: for in-line non-destructive integrity testing of filled aerosol cans using integrity testing, using VDM or PDM analysis.
• Laser Cube: a benchtop headspace gas analysis machine that uses non-destructive, non-invasive laser-based inspection technology for measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

Market sectors & Applications

Bonfiglioli Engineering products and solutions can be applied across a very wide range of industry sectors, including Pharmaceutical and biotech packaging, Medical Devices, Food & Beverage and Appliances.

Applications include:

• Empty / filled verification
• Vial inspection & testing
• Bottle testing & inspection
• Ampoule testing & inspection
• Pre-Filled Syringe (PFS) testing & inspection
• Cartridge testing & inspection
• Blow Fill Seal (BFS) container testing & inspection
• Form Fill Seal (FFS) container testing & inspection
• Sachets / IV Bag testing & inspection
• Flow wrapped device testing & inspection
• Blister packaging testing & inspection
• Bags and Pouches testing & inspection
• MDI/MDPI testing & inspection
• Monobloc testing & inspection
• Medication Tubes testing & inspection

Quality and Regulatory

Bonfiglioli Engineering is an active participant in international industry associations, interest group communities and task forces, which support its

pursuit of absolute quality, attested by the Company’s ISO 9001 quality standard certification. The solutions that Bonfiglioli Engineering designs,

develops and delivers are meant to comply to norms and regulations such as:

• ASTM F2338-09 (Vacuum Decay Leak Testing)
• Good Manufacturing Practices
• USP 1207 (Container Closure Integrity Testing)
• ADR (Aerosol Dispensers)
• FDA 21 CFR Part 11 and EU Annex 11 (relevant to Equipment Software Development)
• EU Annex 15 (relevant to Equipment Qualification and Validation)
• UL 508A (together with other norms relevant to Equipment Electrical Requirements)