Automated Optical Inspection of BFS Containers

Blow-Fill-Seal (BFS) containers are used in various industries to transport liquids. BFS is an aseptic filling process that is often used in the pharmaceutical industry, for example for infusion solutions (IV bottles), rinse solutions, and antiseptics. Typical BFS containers are bottles and single dose units for smaller volumes of liquids, such as eye drops. To ensure that the quality of the product is uncompromised, quality inspections specifically designed for the BFS process are performed once the filling and sealing steps are complete.

Optical Inspection of BFS Containers
VINSPEC HEALTHCARE portfolio of inspections designed for containers, caps, and particle presence in Blow-Fill-Seal bottles and eye drop bottles.

The VINSPEC HEALTHCARE optical inspection system for BFS containers can be seamlessly integrated in production lines, making automated inspection possible during each process step. This inline inspection detects defective containers so they can be immediately removed from the production line, ensuring that defective products are excluded from further processing. As an automated inspection system, VINSPEC HEALTHCARE can be used for cycles at more than 14,000 BFS per hour. The system performs all BFS filling and sealing inspection tasks and ensures that the products are of high quality and reliably defect-free.

This includes both quality inspections and the identification of codes or printed elements on packaging and labels. Furthermore, the system provides inspection data for targeted evaluations and process optimizations by means of yield control and heat maps.

The following describes in detail a BFS inspection with VINSPEC HEALTHCARE. Individual inspections can be combined flexibly upon request.

Among other things, the inspection detects if the cap is missing and if the foil is incomplete, damaged, or missing. Furthermore, the inspection also checks for the presence of solution coding on the cap and for a side imprint (optional). A 360° sensor developed by VITRONIC inspects the entire cap area for contamination and heat damage. The molding ring is also inspected from top to bottom for contamination and heat damage to the plastic material. During inspection, the systems also check to see if surplus material at the neck or shoulder of the containers is present once the cap is overmolded. Surplus material is not permitted. The shape of the body of the bottle is inspected and the inspection looks for possible deformations. Furthermore, inspection systems detect inclusions of foreign material and heat damage to the container material, as well as inhomogeneity in the bottle material or excess material on the outside of the bottle. The systems also inspect the bottom of the container for product residue.   Inspections of the bottom of BFS infusion bottles also ensure that the hanger is attached correctly so that the bottle can be properly hung and verify that is was fully molded to shape. Even the BFS container's filling level is inspected by the systems. Inspection for the presence of particles is also handled by the optical inspection systems. Particles can enter the BFS container while it is being shaped or when it is filled through the mouth area or tubes. Therefore, the systems check that there are no floating or suspended particles in the product solution, a key criterion for reliable patient care when BFS infusion bottles are used.

VINSPEC HEALTHCARE inspection systems can be validated for compliance with FDA and GAMP guidelines. Furthermore, VITRONIC's Track and Trace solution enables the reliable serialization of pharmaceutical products.

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Allan Kotnik

Vice President of North American Industrial Sales

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Dietmar Karepin


Key Account Manager Healthcare

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