With decreasing batch sizes, production lines for sterile pharmaceuticals become more versatile in the type of products and packaging materials to be processed. A CMO approached us and required an inline inspection system for vials of different sizes with water based and oxygen sensitive liquids as well as lyophilized products closed under a nitrogen atmosphere. In addition, glass ampoules filled with oil based liquids were part of the portfolio. The goal was to inspect for multiple quality relevant attributes of the different products.

In a first stage the product portfolio of the CMO was analyzed by their processing parameters and attributes. Based on that, a risk analysis of the inspection tasks were defined in a joint workshop. Besides container closure integrity, other quality relevant attributes such as the residual moisture inside the lyo cake as well as residual oxygen concentrations inside the headspace were required to be inspected in order to meet the customer requirements. Based on that methods developments were implemented and continued with a system design approved. During the early stage of the method development phase, trials with all products and configurations were implemented. Test methods were selected and cycle times got developed.

Three inspection technologies were finally selected and integrated into one platform that was able to process up to 400 units per minute. The system was capable of testing vial sizes ranging from 2R to 100R and ampoules from 1ml to 10ml. Container closure integrity was tested with pressure and vacuum decay as well as the LFC method^®. All oxygen sensitive products were also tested for the residual oxygen concentration by means of Headspace Analysis. Furthermore, a high-speed NIR spectrometer was integrated for a 100% non-destructive check of moisture inside the lyo cakes in the VARIO MTX.