Particle inspection is performed by using the industry standard Static Division (SD) sensor (details). The SD system has been upgraded to include a data storage system. The system stores data for each syringe inspected during validation. Such data can then be recalled and the inspection parameters may be changed, in order to perform tuning offline without running actual product through the machine. An easy to understand graphical display indicates the results of each inspection performed.

The system is augmented by using optional CCD cameras for certain products such as heavy suspensions or high viscosity products.

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Eisai uses Cognex CVL inspection software, which acquires up to 24 images per syringe, now includes color inspection (details). Items such as cap color, plunger color, and product color can now be inspected. Flaws such as cracks in the glass, defective aluminum crimps, broken flange, bent needle, and stopper defects are easily detected.

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SPIN SPEED VERIFICATION

Spin speed is a critical inspection process parameter. To ensure that the syringe is being spun at the proper spin speed, the spindle cap rotation is measured, since the spindle cap rotates directly from the spin of the container.

ADVANCED LED LIGHTING

LED lighting is available at all of the inspection stations, which stabilizes the lamp intensity, and prevents interference from other inspection stations.

NON-VACUUM SORTING

Holding each container in a starwheel is no longer reliant on vacuum. Our innovative design means improved reliability and less change parts needed to hold such containers safely in place.

Syringes are classified as un-inspected whenever validated inspection criteria are not met. An example of this is when the machine has an emergency stop and the containers directly in front of the inspection devices do not have the correct spin condition. Automatic re-inspection allows such syringes to be fed back to the machine's pre-spin table, as well as all inspection stations for proper inspection. Such second pass inspections can be performed for other inspection criteria. The feature is user configurable through the HMI software.

The validation mode has been improved to allow syringes to pass through the pre-spin table, the cosmetic inspection table, and the particle inspection table continuously, in order to provide data during product set up which mimics actual product conditions.

Lot trending is now available in a report which shows the overall percentage of reject rates per inspection station between lots or within sessions during a lot.