Bonfiglioli Pharma - Micro-Leak Detection and Visual Inspection of Pharmaceutical Packaging

For over 30 years Bonfiglioli Pharma has successfully detected micro-leaks in all types of containers. Bonfiglioli detects micro-leaks in plastic containers, filled and sealed ampoules and vials, BFS, blisters, lyophilised 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.

Fully automatic leak tester and visual inspection machine

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. The camera is equipped with cameras to perform particle, level and cosmetic inspection. This machine totally fulfills your need to comply with EU GMP ANNEX 1.

The container is inserted into 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 the container is good or faulty. The same container is then spinned and stopped and several photos are taken. The container is checked for any particles in the product, for cracks and for the fill level. Comparison is done between photos and discrimination made between good and bad container.

Our technology is over 99.9% reliable. It offers very low noise levels and easy cleaning with low energy consumption and maintenance. A remote assistance modem communication package is also available to our customers at very short notice.

Syringe leak tester

Bonfiglioli is the first company to present the market with a solution to leak test pre-filled syringes. High-standard nested syringe filling machines have been developed to automatically fill and seal pre-sterilized nests containing 100 syringes. Bonfiglioli's new syringe leak tester can be customized to the requirements of the client. The nest containing the syringes is fed into the machine. Each individual syringe will be 100% tested and the faulty syringes will be automatically removed from the nest by a pick and place system. The output may reach up to 6 nests per minute.

The new syringe leak tester is fully computerised, utilising a SCADA platform. The software is easy to operate and includes utilities such as a products database and statistical reports. A printer is also installed for printing test results and parameters. Laboratory semi-automatic models are also available. All necessary validation documents are available.

PK-V – vial and BFS container leak tester

This leak-testing machine is designed to detect leaks in pharmaceutical vials and BFS containers up to 600 cpm production output. May be easily integrated in-line or using cassette-feeding systems. The changeover time is of 20min - 45min. Its range of containers tested is 2ml to 1000ml.

PK-VS – non-destructive FFS strip leak detection machine

Conventionally strips have been leak tested by the Methylene Blue dye test or by using a partial testing by a high voltage spark. These methods may now be finally replaced by a clean, highly precise, non-destructive leak tester which may be easily and accurately validated to very small micro leaks.

The PK-VS is fed by a pick-and-place mechanism where the strip is inserted in a testing chamber. Special sensors analyse pressure pattern around the strip when applied under vacuum, rejecting faulty leaking strips accordingly. The PK-VS machine is fully computerised utilising a SCADA platform. An Auto Cleaning Testing Pocket (ACP) mechanism automatically cleans testing chambers when any spilling occurs from a reject strip, eliminating subsequent false rejects. The output may easily reach 180 cpm depending on the number of testing heads. Laboratory semi-automatic models are also available.

PK-A – ampoule leak detector

This leak detection machine is designed to leak test pharmaceutical ampoules up to 400 cpm production output. May be easily integrated in-line or using cassette-feeding systems. The changeover time is of 20min - 45min. Its range of containers tested is 2ml to 20ml. The testing system can utilise both pressure and vacuum.

PK-B – pharmaceutical vial leak detector

This machine is designed to leak test pharmaceutical vials up to 600 cpm production output. May be easily integrated in-line or using cassette-feeding systems. The changeover time is 20min - 45min. Its range of containers tested is 2ml to 1000ml. In this type of machine the testing head utilises a pneumatic seal (blow seal) in order to leak test only the cap of the bottle.

PK-I – pharmaceutical vial leak detector

This machine is a leak detector for pharmaceutical vials up to 50 cpm production output. May be easily integrated in-line or using cassette feeding systems. The changeover time is of 10min. Its range of containers tested is 2ml to 100ml.

BLI - blister pack leak tester

Conventionally blister packed tablets have been tested with Methylene Blue dye. The process is messy and destructive, but can finally be replaced by a clean, precise, non-destructive leak tester that can also be easily validated to micro leaks down to cracks measuring 3 microns across.

The compact BLI machine is fed by stacking the blister packs and a pick and place mechanism inserts into a testing chamber. Special sensors analyse the swelling of each blister cell when set under vacuum then reject faulty blister packs accordingly. The output may easily reach 600 cph making it ideal for non-destructive testing of expensive drugs. Laboratory semi-automatic models are also available.

LVA - freeze-dried (lyophilised) vial leak detector

Until recently freeze-dried (lyophilised) vials were checked for vacuum using a spark test. A revolutionary method has now been developed by analysing the head space pressure inside a vial using laser absorption spectroscopy. Laser absorption spectroscopy is an optical measurement method for rapid and non-destructive gas analysis.

The LVA machine utilises one laser head and may achieve outputs of 600cpm depending on the type of container. An indication of the actual vacuum level is also determined and displayed. The machine includes an auto self test system using calibrated check vials where by the machine is self challenged as frequently as desired to assure 100% reliability.