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Main topic of this conference is the detection of particles in injectables and their evaluation during batch release and continuous process improvement. Besides the current regulatory requirements with regards to particulate matter, routine 100% inspection of injectables will be addressed. Manual inspection as well as automated inspection systems will be covered, including training, AQL testing, trending, inspection equipment and batch release considerations.
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. But still, lots of questions arise, e.g. concerning re-testing, detection capabilities and revalidation of inspection systems.
Furthermore there has been a recognisable trend towards automated inspection machines throughout 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 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 systems.
We will address those topics during the conference and discuss and answer questions on
This conference is directed at specialists and executives from sterile operations, that is manufacturing, quality assurance and engineering. But also suppliers of primary packaging materials and inspections technology are target group of this conference.
The Participants of the Particles in Parenterals Conference receive the current version of ECA’s Best Practice Paper on “Visual Inspection” for free!