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2023 PDA_Training-1988x680

PDA EU00007 Extractables and Leachables

Apr 25 - Apr 26, 2024
Copenhagen, Denmark

Including: Important Regulatory Updates – Case Study Section: Selection of Nelson Labs’ most interesting Case Studies, presented over the last 10 years!

  • Education
  • Europe

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Program Highlights

This training course will look at Extractables and Leachables from many different angles: definitions, regulations, material and polymer science, analytical E/L methodologies, safety assessments, and study design for different parenteral primary packaging systems and injection devices.


When making parenteral drug products, pharmaceutical companies are faced with the need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues (i.e. for biopharmaceuticals) have also become a concern.

This training course will look at Extractables & Leachables from many different angles, including, Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, and Study Design for different parenteral primary packaging systems and injection devices.

A full session will be dedicated to an in-depth update on regulations, standards, and recommendations in this field (PQRI, USP, ISO 10993, BPOG).


  • Day 1
  • Day 2
  • Thursday, 25 April 2024

    09:00 I Introduction and Attendee Expectations

    09:15 I Introduction on Extractables & Leachables (E/L)

    • What is the importance of a good E/L-qualification?
    • Historical cases of leachables, impacting the quality or the safety of a drug product
    • Regulatory requirements (FDA, EMA…) for primary packaging

    10:30 I Coffee Break

    10:45 I Understanding the Materials, Used in the Manufacture of Pharmaceutical Containers & Closures

    • Types of polymers – examples in medical/pharmaceutical use
    • Understanding the composition of polymers: Intentionally added & Non-Intentionally added Compounds: Their function and origin
    • The issues with glass in parenteral applications

    11:30 I The Mechanism of Leaching

    • What are the physicochemical parameters to be considered when trying to understand polymer migration
    • How do leachables move through a polymer, the diffusion model
    • Special cases in migration

    12:00 I Lunch Break

    13:00 I How to Set-up Extractables & Leachables Studies Pharmaceutical Container Closure Systems
    Remote Presentation by Dennis Jenke

    • Selecting the right conditions for extraction
    • How to select the right compounds to monitor in a leachable study
    • Designing a leachable study

    14:45 I Coffee Break

    15:00 I Analytical Techniques to Perform Extractables & Leachables Research

    • The importance of sample preparation: the corner stone in E/L research
    • What are the target compounds for material research
    • How does a classification of these compounds assist in finding the right analytical technique
    • From basic “screening” methodologies to state-of-the-art equipment

    15:45 I How to Perform a Safety Evaluation – Risk Assessment on Extractables & Leachables

    • Toxicology 101
    • EMA Guideline on Genotoxic Impurities
    • ICH M7 (DNA reactive Impurities) and its suggested staged approach
    • The Threshold Concept of PQRI (OINDP and PDP/ODP)
    • Examples

    17:00 I End of Training Course Day 1

  • Friday, 26 April 2024

    08:30 I Recap Day 1

    08:45 I E/L Testing for a Small Volume Parenteral Container Closure systems

    • Glass Syringes: the issues with tungsten, glue residues and silicone oil and glass metals leaching
    • The Issue with rubbers: the plunger, the needle shield or the tip cap: different approaches needed?
    • The impact of secondary packaging – option or necessity?
    • Setting up extractable & leachable studies for a pre-filled Syringe
    • Biological Drug Products versus Small Molecule Drug Products
    • Primary packaging for the lyophilized drug product – modus of interaction with the DP
    • Critical aspects when designing leachable studies for lyophilized DP
    • Reactivity Of Leachables: concern for Lyophized drug Products
    • Integration of the administration procedure (e.g. IV-set, pump system) in leachables evaluation

    10:00 I Coffee Break

    10:15 I E/L Testing for Disposable and Single-Use Systems in Bioproduction

    • How to classify the risk of different single-use systems in the bioproduction process?
    • Understanding BPSA & BPOG recommendations, and how they can be implemented in the study design
    • Performing E/L studies on filters: potential approaches

    11:00 I Large Volume Parenterals

    • The challenge in E/L testing for LVP’s
    • Primary packaging for LVP’s – critical materials and components
    • Secondary packaging for LVP: critical points to consider

    11:30 I Lunch Break

    12:30 I Qualification of Injection Devices used for Parenteral Administrations

    • Short introduction into Medical Device Regulations (ISO 10993 series)
    • Difference in Approaches for Medical Devices, compared to Pharmaceutical Packaging
    • Considerations for Combination Products: how to proceed?

    14:00 I Coffee Break

    14:15 I Updates of E/L- Regulations, Standards and Recommendations

    • Pharma Packaging:
      o Final PQRI recommendations of the Parenteral Drug Product (DPD) Chemistry group
      o USP <661> & USP<665> chapters: where are we, where could it go to?
    • (Bio)Pharmaceutical Manufacturing
      o The BPOG protocol

    15:45 I Q&A

    16:00 I End of Training Course


Piet Christiaens
Piet Christiaens
Nelson Labs NV
Dennis Jenke
Dennis Jenke
Triad Scientific Solutions

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this training course, you will be able to:

    • Explain in detail the current regulatory requirements for container/closure qualification form an E/L perspective.
    • Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
    • Understand the materials of construction, including composition, of container closure systems, and how they could impact the safety and quality of a parenteral drug product.
    • Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.
    • Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study
  • Who Should Attend
    • Pharmaceutical Packaging and Device Engineers
    • Production Engineers, using SU systems
    • Regulatory Affairs Officers
    • Pharmaceutical R & D Managers
    • Analytical Chemists, working on E/L
    • Quality Assurance Officers

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Ellehammersvej 20
Copenhagen, Denmark

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All Participants €2.090

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