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2020 Medical Device

Extractables & Leachables - Fall Edition

Sep 10 - Nov 11, 2019
Madrid, Spain

This workshop will look at "Extractables & Leachables" from many different angles: Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral primary packaging systems, as well as for injection devices.

  • Education
  • Europe

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Program Highlights


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,  also quality issues – i.e. for biophar-maceuticals – have become an additional concern.

This workshop will look at "Extractables & Leachables" from many different angles: Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral  primary packaging systems, as well as for injection devices.

In addition, during the workshop, 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, 10 September 2020

    9:00 – 18:00

    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

    Understanding the Materials, Used in the Manufacture of Pharmaceutical Containers & Closures

    • Types of polymers – examples in medical/pharmaceutical use
    • Understanding the composition of polymers
    • The issues with glass in parenteral applications

    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

    How to Set-up Extractables & Leachables Studies

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

    FULL Session on Updates of E/L- Regulations, Standards and Recommendations

    • Pharma Packaging:
      • Preview of the final PQRI Parenteral Drug Product (DPD) & ODP Chemistry group
      • Update on the most recent developments on the USP <661> chapters
    • Devices
      • Chemical characterization of devices according to ISO 10993-18: What changes are coming up?
      • Upcoming Revisions of the USP <87> and USP <88>: Where could it go to?
    • (Bio)Pharmaceutical Manufacturing
      • The BPOG protocol
      • Where is USP with the update on the USP <661.3> Plastic Manufacturing Components standard

    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
    End of Day 1
  • Friday, 11 September 2020

    9:00 – 16:30

    E/L Testing for a Pre-filled Syringe (Glass & Polymer)

    • 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

    E/L Testing for Lyophilized Drug Products

    • Primary packaging for the lyophilized drug product – modus of interaction with the DP
    • Impact of the “21CFR Part 4” on combination products, used in the administration of a lyo DP
    • Critical aspects when designing leachable studies for lyophilized DP
    • Integration of the administration procedure (e.g. IV-set, pump system) in leachables evaluation

    How to Look at Injection Devices from an E/L Perspective

    • Medical device regulations versus pharma packaging
    • Test selection process for devices: What to do?
    • USP and ISO 10993 series for biocompatibility testing
    • Case: Injection device

    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

    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
    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 workshop, 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 – and their 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

    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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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Novotel Madrid City Las Ventas

Albacete, 1
Madrid, Spain
Phone: +34 91 7247600

Novotel Madrid City Las Ventas
  • Accommodations

    Novotel Madrid City Las Ventas
    Albacete, 1
    Esquina avenida de badajoz
    28027 Madrid - Spain
    Tel: +34 91 7247600
    Fax: (+34)91/7247610

    This modern hotel is conveniently located for both Madrids Barajas Airport and the city centre. After a day of work or travel you can unwind with a swim in the outdoor pool.Both metro and bus lines run directly to the city centre at Puerta del Sol. The trade fair site of Juan Carlos I is 4 km away, and can be easily accessed via the nearby M30 motorway.

    Enjoy a meal on site at the Insólito Restaurant, which serves Spanish cuisine made with fresh products. You can then relax in the Insólito cocktail bar with a drink. The hotel also has a chill out bar at the pool.

    PDA Europe has reserved a limited number of rooms until the 27th July 2020
    Single Room € 137 per night* 
    Double Room upon request

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply
  • Amenities

How to Get Here

By Air


Adolfo Suárez Madrid-Barajas Airport - MAD
Airport Phone: +34 913 211 000
At 5km / 3 miles

By Car

More information coming soon.

Other Options

Train Station: ATOCHA At 9km / 5.63 miles

Train Station: CHAMARTIN At 4km / 2.49 miles


Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (21%)

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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