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2023 PDA_Training-1988x680

PDA EU00007 Extractables and Leachables

Oct 19 - Oct 20, 2023
Gothenburg, Sweden

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.

Overview

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).

Agenda

  • Day 1
  • Day 2
  • Thursday, 19 October 2023

    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 Training Course Day 1
  • Friday, 20 October 2023

    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

Trainers

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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Travel

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More information coming soon.

Mässans Gata 24
Gothenburg, Sweden

  • Accommodations

    PDA recommends the reservation at the following hotel

    Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg,
    Sweden

    PDA Europe has reserved a limited number of rooms until the 15th August 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here

By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.

By Car

E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.

Other Options

From the main railway station take the number 2 tram (towards Krokslätt) or the 4 (towards Mölndal). From Brunnsparken Square you can also take the number 5 tram (towards Torp). The trams stop at Korsvägen / Svenska Mässan. Tram timetables can be found on the Västtrafik website.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.895

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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