Intertek, a leading quality solutions provider to industries worldwide, has been invited to present during the European Compliance Academy (ECA) training course: Leachables & Extractables - Testing & Assessment.
During a drug product life cycle there is a risk of substances leaching into the drug. These potential sources of contamination are known as leachables and they can vary from organic oligomers from packaging, components of printing ink and catalyst residues. Leachables are a complex issue and it is important to consider the potential risk at an early stage of product development. Potential sources of leachables include primary packaging materials and process equipment such as filters, bags or tubes. To assess potential leachables it is necessary to, first, understand the substances that can be extracted from container closure systems into solvents under controlled test conditions, also known as 'extractables'. Comprehensive knowledge of extractables can help in the identification and quantification of potential leachables.
The training course will cover all aspects of extractables / leachables (E/L) ranging from regulatory requirements to routine extractables testing in quality control checks. A key part of the course will be sessions, presented by Dr Armin Hauk, Senior Consultant of the Intertek operation in Basel, on E/L strategies and E/L studies for printing inks.
An expert industry speaker, Dr. Hauk will cover both the strategies and methodologies for E/L studies to help fulfill regulatory requirements and will present an overview of instrumentation and techniques which enable comprehensive qualitative and quantitative analysis in extracts from such studies. Dr Hauk will also provide guidance E/L studies involving printing inks as potential sources of leachables.
"A strategic approach to appropriate extractable and leachable studies can help to address the potential complexity of these issues, mindful of the need for suitable, validated and sensitive analytical methods" shares Dr Hauk.
The Leachables & Extractables - Testing & Assessment, course will take place 14-15 May 2014, Copenhagen, Denmark. For more information on the course and fees please see the ECA website.
During a drug product life cycle there is a risk of substances leaching into the drug. These potential sources of contamination are known as leachables and they can vary from organic oligomers from packaging, components of printing ink and catalyst residues. Leachables are a complex issue and it is important to consider the potential risk at an early stage of product development. Potential sources of leachables include primary packaging materials and process equipment such as filters, bags or tubes. To assess potential leachables it is necessary to, first, understand the substances that can be extracted from container closure systems into solvents under controlled test conditions, also known as 'extractables'. Comprehensive knowledge of extractables can help in the identification and quantification of potential leachables.
The training course will cover all aspects of extractables / leachables (E/L) ranging from regulatory requirements to routine extractables testing in quality control checks. A key part of the course will be sessions, presented by Dr Armin Hauk, Senior Consultant of the Intertek operation in Basel, on E/L strategies and E/L studies for printing inks.
An expert industry speaker, Dr. Hauk will cover both the strategies and methodologies for E/L studies to help fulfill regulatory requirements and will present an overview of instrumentation and techniques which enable comprehensive qualitative and quantitative analysis in extracts from such studies. Dr Hauk will also provide guidance E/L studies involving printing inks as potential sources of leachables.
"A strategic approach to appropriate extractable and leachable studies can help to address the potential complexity of these issues, mindful of the need for suitable, validated and sensitive analytical methods" shares Dr Hauk.
The Leachables & Extractables - Testing & Assessment, course will take place 14-15 May 2014, Copenhagen, Denmark. For more information on the course and fees please see the ECA website.
