A new testing technology has ushered in a new chapter in the inspection of pharmaceutical products. The innovative robotic cell uses a Stäubli TX40 compact robotic arm to facilitate automatic inspection of small batches.
With the development of the RIM, Seidenader is taking the inspection of pharmaceutical products to a whole new level. A compact Stäubli robot and pioneering cell layout are bringing previously unknown flexibility into play to allow automatic inspection of small batches.
The life of a person might well depend on the contents of an ampoule that a doctor opens. It follows, therefore, that the conditions under which pharmaceutical preparations are administered via injections or infusions must be manufactured and packaged under sterile conditions that comply with the most stringent quality assurance specifications. Quality testing involves firstly the reliable detection of particles, fibers and splinters and secondly finding cosmetic and functional defects in the ampoules and bottles.
With more than 115 years experience in constructing plant for the pharmaceutical industry, the Seidenader Group has gained international renown. Seidenader Maschinenbau GmbH specializes in inspection solutions for the pharmaceutical industry and offers full model series of semi-automatic and fully automatic inspection equipment for parenteral, i.e. non-oral, drug administration devices.
This portfolio is completed by a newly designed, automated inspection system which represents a conceptual innovation for Seidenader: At the heart of Seidenader’s RIM (robot-based inspection module) is a Stäubli TX40, a compact and high-precision 6-axis robot.
The advantage of robot handling is without a doubt its enormous flexibility. Martin Engels, CEO at Seidenader Maschinenbau GmbH says: “It was our aim to present an inspection machine that can deliver small batches of reproducible inspection results without human intervention. It was therefore important to map the inspection parameters of a production machine in a compact module, which meant inspection with a number of flexible options regarding the different camera positions and angles and lighting. There is no alternative to using a robot to implement all this in a very small space.”
The list of inspection criteria for parenteral pharmaceutical products and their packages is a very long. It ranges from moving and deposited particles, fibers and splinters in pharmaceutical substances to the fill level. Fluid, freeze-dried and opaque products all need to be inspected. The inspection for cosmetic defects of ampoules concentrates on melting faults and black spots and on cracks in the side walls or base and on defects in caps or crimp seals in vials.
In the RIM, all these tasks can be carried out in a small space in three defined inspection positions with up to four cameras at each one. Positioned centrally in the module, the six-axis Stäubli robot carries out every handling task. Once the products have passed through all the inspection stations, the TX40 places them on the “Good” or “Bad” conveyor, depending on their results.
The handling route taken by the robot is time-optimized depending on the inspection stations it moves to and the number of inspections required in each case. The RIM creates a platform which can be used in a number of ways with flexible grouping of the inspection positions. A double gripper can grasp a wide range of different receptacles, including small ampoules and vials with a minimum of format part changes, changeover times take around ten minutes. This makes automatic inspection of even small batches economical.
With this new flexibility, the RIM offers users the option to develop new sequences with which to train their mass production inspection systems with comparatively less handling and in batches of fewer than 2000 units. There is a significant advantage in the inspection of expensive sample sets which are required for regular revalidation of inspection machines for large series. Seidenader customers all over the world will benefit from this.
It is not by chance that Seidenader has chosen the Stäubli TX40. The robot is of a compact design, is highly precise and easy to integrate in other systems. “The strong expertise demonstrated by the manufacturer in the medical and pharmaceutical industry was important for us. Stäubli robots are state-ofthe- art machines which have been used successfully in these sectors for many years. Their exemplary cleanroom classifications and their guarantee of problem-free operation contributed significantly to our decision,” said Martin Engels.