It takes approximately ten years after its discovery before a new drug product (DP) is on the market when all intermediate test phases are successful. Besides the clinical trials which focus on the efficacy of the drug itself, a number of studies are designed (and obligatory from the regulatory point of view) to study the interaction between the drug product and its container, the so-called extractables and leachables studies. The main objective is to identify the molecules which leach into the DP whereafter a toxicological assessment can be done.
Due to its chemical characteristics, silicone oil is used in a wide variety of applications, from medical equipment to contact lenses and in the manufacture of elastomers. Silicone oil itself is not considered to be a toxic molecule within extractables and leachables studies, but unfortunately the presence of PDMS may have detrimental effects on the drug products (DP) within the container when the DP contains proteins.
Download this free white paper to find out more.
Isolation of aseptic processes is not a new technology. Rigid stainless-steel isolators have been available...