Bonfiglioli Pharma has for over 30 years successfully detected micro-leaks in all types of containers with excellent references worldwide. Bonfiglioli detects micro-leaks in plastic containers, filled and sealed ampoules and vials, BFS, blisters, lyophilized vials and syringes. Bonfiglioli has also supplied high speed combi machines whereby the products are tested for leaks and also visually inspected for foreign particles and cosmetic defects using sophisticated software and CCD cameras.
The PK V Vis Combi is a fully automatic leak tester and visual inspection machine for ampoules and vials up to 600cpm. This leak testing method is according to the ASTM and is fully validated. Being equipped with cameras this machine is able to perform particle, level and cosmetic inspection. Totally fulfills your need to comply with EU GMP ANNEX 1.
The container is inserted in a chamber whereby it is tested by applying vacuum. The PK-V-Vis Combi is equipped with Software based on SCADA through which the pressure pattern can be recorded, analysed and compared to a pre-set pattern, thus indicating if container is good or faulty. Having finished this process, the same container is spinned, then stopped and several photos are taken. Container is checked for any particles in the product, cracks and for the Fill Level. Comparison is done between photos and discrimination made between good and bad container.
Our technology has a reliability above 99.9%. Very low noise levels and easy cleaning with low energy consumption and maintenance. A remote assistance modem communication package is also available as to assist to our customers at very short notice.