Seidenader takes new approach to cytotoxic product inspection

Published: 13-Apr-2011

Also offers HVLD machine that checks for leaking parenteral containers

Seidenader Maschinenbau, a German supplier of inspection technology for the pharmaceutical industry, has developed a system with a new approach to inspecting highly potent or cytotoxic products as used in cancer therapy. It will be demonstrated at interpack 2011 in Hall 16, Stand B47.

Filling these products under isolators has become a standard in the pharmaceutical industry, but inspection of these containers often still relies on conventional manual methods.

Seidenader has developed a robot inspection machine (RIM) for small batches, such as for research and clinical trials, or where automatic inspection is preferred because of the nature of the product or the documentation required.

The core of the RIM is a six-axis robot arm, which picks up container by container from a buffer table and places them into appropriate inspection stations. Upon completion of all inspections it separates defects from good products.

Three inspection positions can be equipped with different cameras providing more flexibility of inspection views and an increased number of images. The inspection stations are similar to those used in conventional Seidenader inspection machines – for special requirements they can be suitable for isolator environments, and robust against product, cleaning agents and neutralising fluids.

The customer has the flexibility to operate one or more Seidenader RIM units in parallel or synchronised “hand in hand“, in isolators which are connected to capping machines or exterior decontamination machines.

The base module inspects up to 15 liquid filled vials per minute for particles, fill level, cracks or defective closures, and checks lyophilised products for overall appearance, particles and other cosmetic defects. The robot can be equipped to handle vials, ampoules, syringes and special containers from 1–100ml.

Also new from Seidenader is the HVLD inspection machine for vials, ampoules, cartridges and syringes, which checks for leaking parenteral containers and closures using high voltage.

The machine uses high precision electrodes to inspect the full circumference of the containers including the closure zone at speeds up to 600 containers/minute.

All containers are presented individually to the electrodes in a horizontal rotation. Any moisture penetrating through capillary forces through a crack, pinhole or just weak glass will be registered as a change in resistance. All products with a measured voltage higher than a defined maximum value will be separated from the good products.

The containers are supported at the top and bottom, which allows the product to be smoothly rotated and presented precisely and reproducibly, and thus closer to the electrodes than with roller or timing screw handling. Due to the smaller distance between product and electrodes, Seidenader says the false reject rate is minimised and the HVLD system works with lower currents than conventional systems.

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