Extractables & Leachables - Live Online Training

7/8 May 2024

Course No. 21313



Gaby Reckzügel

Gaby Reckzügel

Boehringer Ingelheim Pharma

Dr Armin Hauk

Dr Armin Hauk

Sartorius Stedim Biotech

Dr Andreas Nixdorf

Dr Andreas Nixdorf

SGS Institut Fresenius

Dr. Katrin Buss (invited)

Dr. Katrin Buss (invited)

Quality Assessor

Dr Ana Kuschel

Dr Ana Kuschel

Sartorius Stedim Biotech

All times mentioned are CEST.


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 E&L testing will become a topic of major concern.
Within the scope of this Live Online Training, all relevant aspects of Pharmacopoeia/GMP-compliant E&L testing will be addressed ranging from regulatory requirements to routine testing in quality control.
Experienced industry & authority 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 E&L studies.
  • perform E&L 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

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Extractables & Leachables - Live Online Training

Seminar Programme as PDF

Day 1
Introduction to Plastics used in Medical Applications
  • Classification of Plastics
  • Physical and chemical characteristics
  • Different types of additives in plastics
Regulatory Perspective (Authority View)
  • Applicable Guidelines (EU)
  • Update on ICH Q3E
  • Experiences in regulatory submissions
Regulatory and Scientific Perspective (Industry View)
  • 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 E&L testing
  • Scientific Aspects
Q&A Session 1
How to Prepare a Successful E&L Study
  • E&L 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
Strategies 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
Suitability of Packaging Systems for Medicinal Products: Compendial Perspective
Rationale and current thinking around USP’s packaging Standards
  • ƒHow Chemical Characterization is being integrated into USP packaging Standards
  • ƒUpdate on USP plastic, glass and elastomeric standards
  • Characterization of components used to manufacture drug products
  • Proposals for SST Mixtures in support of chromatographic screening
Q&A Session 2
Day 2
Elastomeric Closures in E&L Assessment
  • Composition of Elastomers used for Pharmaceutical Applications
  • Discussion Material Composition and Extractables (Potential Extractable List)
  • Approaches to minimize Extractables/ Leachables from Elastomeric Closures
  • Case Study presentation
Extractables from Glass
  • Glass composition
  • Type of extractables from glass
  • Risk evaluation of glass extractables
  • Concepts to avoid extractables from glass
Control and Life Cycle Management of E&Ls
  • Batch-to-batch consistency in composition and purity of packaging components
  • Acceptance criteria for Extractables/Leachables
  • Quality agreements with suppliers
  • Change Management
Q&A Session 3
QSAR Tools in Toxicological Risk Assessment of E&Ls
  • Endpoints required for a Toxicological Risk Assessment
  • Which endpoints can be covered by QSAR Tools?
  • Free or commercial Software?
  • Acceptance by authorities
  • Demonstration of assessments with QSAR tools
  • In vitro studies as support of QSAR Tools
E&Ls for SUS as Elements of Process Qualification/Validation and Safety Assessment
  • Single-Use process equipment (e.g. filters, bags)
  • Risk-based evaluation and testing strategies
  • Influence of leachables on
    • biopharmaceutical process performance
    • the stability of biopharmaceuticals
    • the analytics of biopharmaceuticals
Simplified E&L Assessment using prior Knowledge and IT Solutions
  • Prediction of extractables profiles for SUS of different sizes and complex assemblies
  • Calculation of exposure data, with a subsequent automated safety-assessment; including a discussion of deviations and propagation of deviations
  • Equivalence study of extractables profiles from an SU assembly before and after a component change, including the evaluation of the impact on the safety assessment
  • Using the system to extrapolate extractables data to USP <665> conditions for a safety assessment of a large volume injectable drug product
Q&A Session 4


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

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