Interaction studies with primary packaging materials (Leachables & Extractables Studies)

For over five years we have been contracted for interaction studies with primary packaging materials. This includes the simple analysis of authority requests or complete qualification studies of packaging materials. The primary packaging can be very complex, consisting of many different materials. In the past we have gained elaborate experience with PE and PP plastics, siliconised rubbers as well as acrylates. For many materials we have developed generic methods which can be adapted to suit your product. This includes the analysis of highly volatile and volatile compounds by GC-MS as well as soluble compounds by HPLC-UV-MS. Our primary packaging material studies start with an extractable study in which we test all material that could potentially leach into the product. In the next step, stored or stressed samples are analysed to see, if any of the previously identify extractables actually migrate into the product. For the identification of leachables we have established an LC-MS database with the most commonly used plastic additives. So far all the extractable and leachable studies conducted by our laboratory were accepted by the regulatory authorities.


 

Interaktionsstudien mit dem Primärpackmittel (Leachables & Extractables Studien)