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2021 UPS_1988x680

PDA EU00007 Extractables and Leachables

May 31 - Jun 01, 2022
Basel, Switzerland

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 & 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.

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

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

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Agenda

  • Day 1
  • Day 2

  • Tuesday, 31 May 2022

    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

  • Wednesday, 01 June 2022

    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
Bio
Piet Christiaens
Nelson Labs NV

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US), where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).

From 2001 onwards, Dr. Christiaens holds the position of Scientific Director at Nelson Labs (formerly Toxikon Europe) where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of extractables and leachables and developing state-of-the-art analytical methodologies. In the last decade, Dr. Christiaens has been a speaker on the subject of “extractables and leachables” at over 150 Conferences, and since 2014, he has been engaged in the two-day Extractables and Leachables training courses that are hosted by PDA across the Globe. In his current role at Nelson Labs Europe, Dr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.
Dennis Jenke
Dennis Jenke
Triad Scientific Solutions
Bio
Dennis Jenke
Triad Scientific Solutions

Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than three decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding).

He has published extensively in the areas of analytical chemistry, environmental science and material/solution compatibility and serves as an expert reviewer for numerous pharmaceutical and analytical journals. He is the author of the book Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables and a contributing author to the Leachables and Extractables Handbook. Dennis Jenke is a member of numerous industry groups whose charter is to establish best demonstrated practices in the area of material/solution compatibility.

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 – 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
    • 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

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.

Congress Center Basel

Messeplatz 21
Basel, Switzerland
Phone: +41 58 206 28 28

Congress Center Basel
  • Accommodations

    Training Location

    Congress Center Basel
    Messepl. 21
    4058 Basel, Switzerland

    Hotels Nearby

    PDA Europe recommends the reservation at one of the following hotels.
    The general terms of business are valid at the event hotels.

    Pullman Basel Europe
    Clarastrasse 43
    4058 Basel
    Switzerland
    Tel: +41616908080

    The Pullman Basel Europe is a vibrant and outstanding upscale hotel within walking distance of the old town, the Rhine river and only 200 m from the Congress Center Basel (Messe). Apart from the fashionable and luxuriously appointed rooms, the modern Fit Lounge and a charming bistro with regional cuisine, it also boasts a green inner courtyard to relax.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

    Hyperion Hotel Basel
     Messeplatz 12
    4058 Basel
    Switzerland
    Tel: +41 61 5604000

    The Swissôtel Basel (4**** superior) offers elegant guest rooms and real Swiss hospitality for an authentic Alpine experience. The rooms boast hand-picked, unique furnishings and calming tones with splashes of vibrant yellow. In-room technology, WiFi, workspaces and entertainment centers are complemented with Italian coffee machines and quality en-suite amenities to help you get the most out of your stay.

    It is centrally located directly connected with the Congress Center Basel (Messe) and within walking distance of the old town, the Rhine River and numerous sight-seeing spots.

    The Basel SBB Train Station is 2 km away and there is parking space available for free for guests. Guests benefit from free access to public transport in Basel with the complimentary Basel Card.

  • Amenities

How to Get Here

By Air

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the venue. A direct bus (Line Nr. 50) runs every 20 minutes A direct bus (Line Nr. 50) runs every 20 minutes taking you to the SBB train Station. A taxi takes approximately 10-20 minutes to the venue.

By Car

The exhibition and congress site has its own direct link to the A2 motorway. The “Messe” exit will take you straight to the Messe Basel car park with its 1,200 parking spaces.

Other Options

From the SBB/SNCF railway station, it’s a ten-minute journey on the No. 1 or 2 Tram to the “Messeplatz/Exhibition Square” stop where Messe Basel and the Congress Center are located. From Badischer Bahnhof railway station, “Messeplatz/Exhibition Square” is the second stop on the No. 2 or 6 tram.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.795

All fees given in Euro and excluding VAT





* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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