Pre-Conference Course Fundamentals of Visual Inspection State-of-the-art Visual 100% Inspection

The training course on visual inspection which takes place before the Particles Conference gives you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system on the basis of the manual inspection and how to qualify it.

In most cases particles found in parenteral medicines will lead to a quarantined product or even to the recall of the product – as we have seen in the last years in the cases of several Pharmaceutical companies. Responsible staff in charge will have to start root cause analysis to find the source of the particles and will have to do an evaluation of batches already shipped.

There is still confusion within the global pharmaceutical Industry with regard to the requirements for testing for visible particles. After the USP chapters <790> and <1790> were published, things have become much clearer, at least for the US. In Europe chapter 5.17.2 of the European Pharmacopoeia now also gives further advice. However, many questions remain, e.g. concerning training, re-testing, detection capabilities and revalidation of inspection systems.

Furthermore, there has been a recognisable trend towards automated inspection machines throughout the last years. High expectations are also placed on the use of artificial intelligence. The challenge for pharmaceutical companies is to find a suitable machine for their products and to determine reasonable inspection parameters during qualification and validation. But also during routine process there are questions arising like re-testing and the usage of test-sets, doing AQL-Testing as well as the Adjustment of parameters of the vision system.

We will address those topics during the conference and discuss and answer questions on

The fundamentals, such as training of operators in Manual inspection, AQL testing, trending and the validation of an AVI System are content of the Pre-Conference course on November 5th.