Control of Parenterals Container-/Closure-Integrity Testing & Visual Inspection Systems

Container/Closure Integrity Testing of Parenterals:

Different products and different container types require different testing methods: this event aims at giving an overview of the different CCI testing systems which are applied during production and as part of the quality control system. Apart from technical aspects the regulatory requirements on CCI testing will be highlighted as well as the applicability of inline and offline testing.

Visual  Inspection Systems:
Main topic of this course is the detection of defetcs like particles in injectables and their evaluation during batch release. 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 validation, training, defect categories, AQL testing, trending and batch release considerations.

Container/Closure Integrity Testing of Parenterals:

An intact container closure system, which is the sum of packaging components that protect the dosage form, is the pre-requisite for a safe and sterile drug product. The CC system protects the product from microbial contamination and also from exposure to gases or water vapour or the loss of solvent. Container Closure integrity testing is therefore a regulatory requirement and it is part of the whole life cycle of a sterile drug product.

Initially this testing was performed as part of the initial development of the packaging system and the system’s suitability verified in stability studies including on-going stability.

Over the years, the expectation was raised to perform batch by batch verification with latest trends to 100% inline or offline testing wherever possible.

We will discuss and answer questions like:

Visual Inspection Systems:
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