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Product category: Vision and scanning systems
News Release from: Industrial Technology Systems (ITS) | Subject: Vision systems
Edited by the Manufacturingtalk Editorial Team on 14 November 2002

Vision gives 21CFR11 compliant product
integrity

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A pharmaceutical company required a critical check performing on an aspect of its product which could affect its sterility, and ITS engineered the vision system to suit

The role of machine vision systems has become increasingly important to the manufacturing community over recent years In an environment of higher productivity and more stringent regulatory requirements such techniques offer the user the capability to increase their product throughput whilst simultaneously helping to increase the quality of the item which is shipped to the end user

The benefits usually mooted of vision inspection systems; accuracy, speed etc are all certainly true.

However many potential users of the technology may still not realise the full end benefits to their process; the increase in compliance with manufacturing regulations, the reduction of returned products, the ability to produce electronic records of batch performance, increased traceability and capability to integrate with higher management-level software.

Regulatory requirements, especially for food and drug production, more or less imply that somewhere along the production line a machine inspection system will be required as opposed to the traditional human-based inspection station.

Exceptional increases in computing power have opened the door to new applications previously thought of as impossible.

Nowadays multiple cameras can be connected to a standard (albeit fast) desktop computer with suitable hardware.

Product processing speeds into thousands per minute are easily achievable.

Lighting and optical technology and techniques (an area so often overlooked as part of the critical engineering of a vision system) continue to develop the potential of automated inspection.

Why look at vision? A common application area is inspection of product component presence or correct fit of an object.

For example a human may be capable of inspecting 100% of the products passing at a rate of 1 unit a second on a production line.

No easy feat in itself, especially as the concentration of the operator will wander with time.

Now due to an increase in productivity requirements the same line speed must be increased to 10 units per second.

Suddenly the task becomes impossible for the operator to deal with.

Of course more people could be employed to inspect the products, however confidence in computerised vision inspection systems has grown so high that more and more companies look at automated vision inspection as a more cost effective and reliable solution.

In a real-world application a pharmaceutical company required a critical check performing on an aspect of their product which could affect its sterility.

The level of accuracy and speed which was required could only be made feasible by using a vision inspection system.

Industrial Technology Systems Limited (ITS) provided a full solution by supplying and engineering the vision system exactly to the customer's specifications then performing on-site validation and subsequent support.

The acceptable tolerance on the component fitting had to be measured in the sub-millimetre region (almost impossible to see with the naked eye) at a rate of 3 products per second.

Every product that is manufactured on the line passes the camera ensuring 100% inspection of the critical features.

Due to normal mechanical tolerances of the equipment it was important to employ a package which could accommodate movement of the product from image to image.

This was achieved by splitting up the image processing into 'regions of interest' (or ROIs) for faster processing and implementing a 'location-of-known-feature' technique which could reposition the ROIs as the product position shifted.

Careful design of the optical configuration by ITS' engineers meant that only the relevant features were presented in the image.

As the critical part of the product was fabricated from a transparent material a special technique was employed to present the required edges of the object in silhouette.

This allowed the necessary gauging measurements to be made accurately.

A user friendly interface was created by ITSū team which ensured that only appropriate personnel had access to the system via a series of user groups.

These permitted access to a sub-set of the full functionality of the system.

In this way control was brought to the operation of the vision system with the additional benefit of a reduction in the risk of tampering.

Information concerning the performance of the batch in progress was displayed continuously to the operator.

As the operator was required for many other duties on site the system provided a means to retain a series of reject images which could be browsed at a later time to determine the reason for any excessive amount of rejects and hence dictate remedial action.

The system was designed and built to comply with GAMP.

Following installation at site the system was validated by ITS' team to ensure that it meets GAMP and 21 CFR Part 11 compliance.

The entire project featured a full suite of supporting documentation from specifications through to technician training documents.

Customer gains A previous system which had been installed for the same application suffered from a lack of robustness in dealing with varying product presentation.

This in turn lead to a large amount of false rejects and reduction in yield.

Without compromising throughput or quality the new vision inspection system performs exceptionally better at the task and is much simpler for the operators to set up and run.

With the new system optical character verification is far more flexible.

This means that the system can deal with different font sizes and qualities of fonts.

Operators have the ability to train the system to accept text that is visually recognisable.

As a result of these benefits ITS' pharmaceutical customer is looking to deploy this system on similar product lines.

Advancements The capabilities of vision software extend far beyond the usual gauging, and print inspection required on the production line.

With increased intelligent processing e.g by neural networks and fuzzy logic for pattern classification and recognition it is feasible to consider other applications both inside and outside of the production environment.

Not only does more advanced software become available regularly but the hardware it demands continues to advance with higher resolution cameras, new lighting systems and frame stores.

It is clear that machine vision is firmly established as a necessary part of the production process.

Without doubt, companies (manufacturing or otherwise) can only benefit from investing in this maturing technology.

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