Operations Director, Chemistry, Medical Device Testing
United KingdomContact Michael
This technical poster produced by Smithers extractables and leachables experts shows the effects of different sterilization methods on a selection of polymer packaging materials and is now available to download.
In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change in a drug product’s immediate packaging materials, there is a regulatory requirement to assess the impact of the change.
This poster shows examples of extractables assessments performed to assess changes in
packaging sterilization methods.
Find out more about the extractables and leachables testing services that Smithers offers.