Pre-Conference Course "Fundamentals of Visual Inspection & AQL Testing"
Im Auftrag der ECA Academy

Zielsetzung

The training course on visual inspection 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 manual inspection.

Hintergrund

The 100% visual inspection of sterile injectable products is a requirement originating from the Pharmacopoeias, e.g. from the US USP or the European PharmEur. But 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. However, many questions remain, e.g. concerning re-testing, detection capabilities and revalidation of inspection systems.

Furthermore, there has been a recognisable trend towards automated inspection machines in the last years. 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 questions also arise during routine processes like, for example re-testing and the usage of test-sets, doing AQL-Testing as well as the adjustment of parameters of the vision systems.

Due to the lack of precise requirements the ECA Visual Inspection Group has developed a Best Practice Guidance. This paper is very helpful during daily business and answers many questions in its chapters:

• Automated inspection
• Manual inspection
• Inspection of lyophilized product
• Defect classes
• Evaluation of defect classes and trending
• Batch release

Bonus for the participants of this course:

The AQL Inspector’s Rule - A tool for conducting AQL Testing.