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A pharmaceutical company is performing image processing using Cognex In-Sight vision systems and Visionpro software to ensure quality control, process optimisation and product traceability.

Complete system solutions have to perform image-processing tasks for quality-assurance purposes and fulfil different international standards and directives, as well as considering the reliability of computer-supported systems.

For example, the system must comply with the regulations of the EMEA, the FDA and the EU GMP4 directives.

One of the most difficult requirements is that the system solution must be equipped with a user-administration and audit system, which can record all changes made to the system in full detail.

The system developer Krempien+Petersen Qualitats-Kontrollsysteme checks and validates processes to make sure that the process in question can supply a product that meets previously determined specifications and quality requirements.

After the initial contact between the two companies in 2003, the first system installed was an image-processing system for checking the fill level of glass ampoules or vials.

Since the initial contract, six additional filling systems have been equipped with PC-based image-processing systems based on Cognex Visionpro software and the vision systems from the Cognex In-Sight product range.

The vision systems from the In-Sight 5400 range are capable of the non-stop, three-shift production-line operation of the pharmaceutical company.

Integrating the vision systems into the production line was said to be easy because of their compact design and integrated Ethernet interface.

The In-Sight vision systems can cope with the high-throughput rates of the various production lines because of their powerful internal processors, and they are able to precisely and repeatedly perform a range of inspection tasks on every ampoule.

The image-processing systems perform checks on ampoules of various types and sizes to determine that they have the correct fill level, colour code and label, as well as verify that the imprint is positioned correctly.

It also verifies the printed ID data, which is present in both human-readable and coded format, to ensure that the information is complete, correct and readable.

The last step – OCV (optical code verification) – is important as a ‘read after write’ step is always required to ensure 100 per cent text quality.

The In-Sight 5410 system verifies the code quality using the Cognex IDMax vision tool algorithms, which are based on the geometrically oriented and patented Cognex Patmax technology.

The reliable operation of IDMax also makes it possible to set tolerances for code distortion and ‘dirtiness’ of labels.

Since the codes are read with 100 per cent reliability, full product traceability is ensured.

Feeding the results back to the labelling machine means that it is possible to ensure that the printing process maintains the required quality standards; the read/no read acceptance threshold can be set higher; maintenance cycles of the writing device can be detected at an early stage; frictional losses in the overall process can be minimised; and nuances detection is reliable.

On one of the production lines, every ampoule is checked for the correct pharmaceutical code, an OCV check of the print quality is performed and the colour code is checked.

Two In-Sight 5400s are used to check the label print quality and the code, while a PC-based colour image-processing system with Visionpro software is used to check the colour code.

The contents of every ampoule is precisely defined by means of coloured rings and the system must be able to recognise the colours without any risk of mix-up.

If a coloured ring is interpreted incorrectly, a ‘major alarm’ is triggered, as this represents a possible product mix-up, and the production line is stopped.

The production line cannot be restarted by the machine operator but must be restarted by an authorised employee.

Correct recognition of the colour on the ring is important on this line.

The colour coding consists of a combination of the three coloured rings, each of which comes in seven different colour variants.

Some of the colours are very similar to each other and the rings are always slightly different.

The coloured paint of the rings can vary in width and thickness, which causes some rings to have a different visual appearance and changes the viewer’s physiological perception of the colour.

Perception of colour can also be affected by the level of transparency of the glass, the content of the ampoules and changes in ambient conditions.

The ampoule-sterilisation process can also alter the colour of the coloured rings.

The system used to check the colour coding must reliably provide repeatable results.

The image-processing algorithms of the Visionpro software operate extremely sensitively and are able to complete complicated tasks, such as in this example, with high reliability.

Visionpro can differentiate colours by using the additive/subtractive colour model of RGB/CYMK, as well as the advanced HSV (Hue Saturation and Value)/HSB (Hue Saturation and Brightness colour model.

Using these precise vision algorithms from Visionpro, the company has been able to practically eliminate the occurrence of false errors.

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