Leachables and Extractables - Live Online Training Testing & Assessment from Packaging to Single Use

Leachables and Extractables - Live Online Training

Course No 20620

This course is part of the GMP Certification Programme "ECA Certified Packaging Manager". Learn more.

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Lothar Fruth, Tox Expert, Germany
Dr Armin Hauk, Sartorius Stedim Biotech, Germany
Dennis Jenke, Triad Scientific Solutions/USP, USA
Dr Ana Kuschel, West Pharmaceutical Services, Germany
Dr Lukas Mogler, Lonza, Switzerland
Petra Motzkau, Sartorius Stedim Biotech, Germany
Dr Andreas Nixdorf, SGS Institut Fresenius, Germany
Igor Petrovic, Intertek, Switzerland
Gaby Reckzügel, Boehringer Ingelheim Pharma, Germany
Dr Jörg Zürcher,  Bayer, Germany


Over the last years, the requirements on the assessment of substances that could leach into the drug product in the course of its life cycle have increased considerably.
The specific kind of extractable/leachable can vary from organic oligomers and catalyst residues to heavy metals – to name a few. Due to the resulting complexity, it is very important to consider the potential risk factors associated with leaching substances already at a very early stage in process development. Therefore, the ICH is currently working on a new ICH Q3E Guideline for Extractables and Leachables (E&L) to “assist both applicants and regulators by providing focus on critical aspects, and improving transparency in requirements for medicinal products including drug delivery device components”.
Packaging materials have been in the focus of such investigations for a long time as the contact time between drug product and packaging material is rather long. But in addition, you have also to consider other possible sources of contamination. Recently, particular attention was paid to devices and equipment used in the production process itself, e.g. filters, bags, tubes. The trend towards single-use equipment might relieve the pressure on cleaning validation and the need to introduce control strategies along the supply chain to avoid unintentional added impurities in materials. At the same time leachables/extractables testing will become a topic of major concern.
Within the scope of this Live Online Training, all relevant aspects of Pharmacopoeia/GMP-compliant leachables and extractables testing will be addressed ranging from regulatory requirements to routine extractables testing in quality control.
Experienced industry speakers share their in-depth knowledge with you.

Target Group

This Live Online Training is designed for personnel of pharmaceutical companies and their suppliers who
  • are responsible for setting up extractables & leachables studies.
  • perform leachables/extractables testing.
  • work in quality control of packaging materials.
  • specify and select polymeric, glass and rubber materials in process development.
  • specify and select Single Use Equipment for manufacturing.
  • develop materials sourcing strategies.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Introduction to Plastics Construction and Related Additives
  • Classification of Plastics
  • Physical and chemical characteristics
  • Different types of additives in plastics
Introduction to Extractables and Leachables - Regulatory and Scientific Perspectives
  • Regulatory requirements of EMA and US-FDA
  • Compendial requirements and foodstuff regulations
  • PQRI recommendations and ICH Guidelines: Safety Thresholds and Permitted Daily Exposure
  • USP <1663>, <1664>: Best Practices for Extractables & Leachables testing
  • Scientific aspects
How to Prepare a Successful E&L Study
  • Extractables & Leachables Study organization for finished packaging’s, timely planning
  • Extractables study designs as part of material qualification and selection
  • Selection of extraction conditions and methods
  • Identification categories, trustable identification
  • Semi-quantitation, analytical uncertainty
  • Analytical methods, target analysis or screening or both
  • Analytical sensitivity adjustment, correlation with analytical evaluation threshold
  • Impacts of sterilization methods on materials chemical composition
Q&A Session 1
Extractables and Leachables in Quality Control and Life Cycle Management 
  • Batch-to-batch consistency in composition and purity of packaging components
  • Acceptance criteria for Extractables/Leachables
  • Quality agreements with suppliers
  • Change Management
Determining the Suitability of Packaging Systems for Therapeutic Products: Compendial Perspective
  • Rationale and current thinking around  USP’s packaging Standards
  • How chemical characterization is being integrated into USP packaging Standards
  • Current, and future, changes to USP plastic, glass and elastomeric Standards
  • Chemical characterization of component used to manufacture drug products
Extractables from Glass
  • Glass composition
  • Type of extractables from glass
  • Risk evaluation of glass extractables
  • Concepts to avoid extractables from glass
Q&A Session 2
How to Prepare a Successful Leachables Study Strategy for Complex Formulated Drug Products
  • Analytical method requirements, validation of Leachables analytical methods
  • Development of Leachables strategies based on Extractable profile and toxicological Report
  • How to deal with trustable and poorly characterized chemical profiles
  • How to establish the “chemical link” between Extractables & Leachables
  • Leachables observed only in Leachables study but not in the Extractables study: What to do?
  • OOS case
Including Elastomeric Closures in Extractables/Leachables Assessment
  • Composition of Elastomers used for pharmaceutical applications
  • Discussion material composition and Extractables (Potential Extractable List)
  • Approaches to minimize Extractable/ Leachable from elastomeric closures
  • Case Study presentation
The Interpretation and Use of Extractables Data; from Extractables Data to Potential Exposure Estimations
Physical-chemical principles of extraction versus Extractables protocols
  • The use of extractables data  in Scaling and Combination exercises
  • The use of extractables data in exposure estimations
  • Differences in data interpretation for CCS and SUS
  • Quantitative mitigation concepts for the assessment of SUS
Q&A Session 3
Differences in the Toxicological Evaluation of Substances for Medicinal Products to other Regulatory Fields like Medical Devices explained
  • For the same substances often different toxicological thresholds (PDEs) can be found, which may confuse non-toxicologists
  • Possible reasons are explained in this session
  • Differences in the Derivation of toxicological thresholds for Medicinal Products and Medical Devices are demonstrated by examples
  • Criteria for the assessment of the validity of toxicological thresholds are discussed
Practice Session on Strategy for Compliant/ Reasonable Leachables Studies
In the course of this session we will develop a strategy for conducting a compliant and reasonable leachables studies. The task will be based on an industry example and will answer the following questions:
  • Which activities are necessary during the development phase?
  • How will we deal with quality control during routine production?
  • Where will we find useful information about the material we are going to use?
USP Strategy for Developing Standard for Plastic Components and Systems Used on the Manufacturing of a Drug Product
  • Objective of Standard
  • Risk based approach outlined in the Standard
  • Rationale for solvent chosen for standards
Q&A Session 4
A Reasonable E&L Design for Complex Products
  • Summary of the different steps to be addressed for a proper Extractables-Leachables Screening Study
  • Illustration of different study designs which may be applied for complex materials consisting of many different parts
  • Importance of a Leachables check experiment as part of the formal Extractables screening study
  • Case studies/examples of complex materials, such as, nasal spray device, multilayer bag from single use dosage system
Leachables During Manufacturing
  • Single-Use process equipment (e.g. filters, bags)
  • Risk-based evaluation and testing strategies under consideration of critical success factors for the pharma/biotech industry such as cost efficiency, time-to-market and regulatory compliance
Interference of Leachables with Biopharmaceuticals During Manufacturing, Storage and Administration
  • Influence of leachables on biopharmaceutical process performance
  • Influence of leachables on the stability of biopharmaceuticals
  • Influence of leachables on the analytics of biopharmaceuticals
Q&A Session 5
E&L Studies from (Bio)Production Process to Final Formulation – Coordinated Study Design, Typical Pitfalls and Solutions
  • How to derive a suitable study design covering all steps from production process to final container closure system
  • Extractables from multi-material-equipment and how to clarify their source
  • Advantage of a leachables simulation study
  • Challenges during leachables method validation
  • Justification for leachables monitoring and typical observations
    • Temporary leachables detected during stability study
    • Unknown leachables and how to identify them
Practice Session Bio Manufacturing/SUS
In this session we will handle examples of Leachables studies in the field of  biopharmaceutical manufacturing.
These examples will base on industrial and contract lab issues and challenges relating to modern process strategies.
Q&A Session 6

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