Join us and learn about the new requirements for assessing substances that could leach into a drug product during its life cycle.
Our expert, Dr Andreas Nixdorf, will present on the topic “Leachables Design Studies Strategy in Complex Formulated Drugs” at 1:00 pm CEST. Other speakers include Dr Armin Hauk, Sartorius Stedim Biotech GmBH and Gaby Reckzügel, Boehringer Ingelheim Pharma GmbH & Co. KG.
Background
Leachables/extractables testing is becoming a topic of major concern. Over the last several years, the requirements for assessing substances that could leach into a drug product in the course of its life cycle have increased considerably. Leachables that must now be identified can vary from organic oligomers and catalyst residues to heavy metals – to name just a few.
Because of the complexity of these requirements, it is very important to consider potential risk factors associated with leaching substances at a very early stage in process development. For quite some time, packaging materials have been the focus of such investigations as there is a long contact time between the drug product and its packaging material.
However, other possible sources of contamination must be considered. Recently, particular attention has been paid to devices and equipment used in the production process itself, e.g. filters, bags and tubes. The trend toward single-use equipment might relieve the pressure on cleaning validation, while the need to introduce control strategies along the supply chain may prevent unintentional impurities from being added to materials.
Who Should Attend This Seminar?
This course is designed for those working for pharmaceutical companies or their suppliers, who are responsible for:
- Qualification of extractables/leachables during quality control
- Performing leachables/extractables testing
- Quality control of packaging materials
- Choosing and defining polymeric, glass and rubber materials in process development
- Choosing and defining single use equipment for manufacturing
- Developing materials sourcing strategies
Date/Time: July 2, 2020 | 8:30 am - 4:30 pm CEST
For further information, please contact:
Josée Leach
Global Marketing Manager – Life Sciences
SGS
m: +44 7889 939 512