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Extractables & Leachables - Spring Edition

Feb 27 - Feb 28, 2020
Basel, Switzerland

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

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 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...).

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Agenda

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  • Day 1
  • Day 2

  • Thursday, 27 February 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, 28 February 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

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, Texas where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-Polymers (Kraton Polymers). Since 2001, Mr. Christiaens has been Scientific Director developing analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. Mr. Christiaens oversees all laboratory operations at Nelson Labs Europe and supports the European business development team.

John Iannone
John Iannone
iCG Solutions
Bio
John Iannone
iCG Solutions

John Iannone has a background in Biomedical Engineering from Boston University. Since joining the Biotech/ Medtech Industry 15 years ago, John has assisted multiple pharmaceutical & medical device companies with the development of their product safety evaluation strategies. Currently he is a Principal Consultant for iCG, LLC. His areas of expertise include Material Qualification & Biocompatibility, Extractables & Leachables, Chemical Characterization, and attainment of Biological or Toxicological risk assessments for medical devices, pharmaceutical container systems, bioprocessing systems, and combination products. John has given numerous technical presentations and has led many workshops on Extractable & Leachable Considerations, Biocompatibility, Microbiology, and Regulatory Testing Requirements. He also participates in the development of both industry groups’ recommendations and regulatory guidelines through Expert Panel membership, global Technical Committees, and industry collaborations.
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 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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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

Messepl. 21
Basel, Switzerland
Phone: +41 58 206 28 28

Congress Center Basel
  • Accommodations
    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.

    PDA Europe has reserved a limited number of rooms until the 06th January 2020

    • Single Superior Room CHF 220 per night*
    • Double Superior Room CHF 240 per night*

    You can book your Hotel Accomodation here!

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

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

    Swissôtel Basel
    Messeplatz 25
    4005 Basel
    Switzerland
    Telephone : +41 61 555 3333
    [email protected]

    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 centres 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.

    PDA Europe has reserved a limited number of rooms until the 06th January 2020

    • Single Superior Room CHF 255 per night*
    • Double Superior Room CHF 285 per night*

    You can book your Hotel Accomodation here!

    *Rates are per room and night, including the following services and benefits:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Pullman Basel Europe:

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. 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 hotel.

Swissôtel Basel

Basel's Euro-airport Basel-Mulhouse-Freiburg (BSL) is situated approximately 8km from the hotel. 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 hotel.

By Car

Swissôtel Basel

Exit ‘Basel Nord/Kleinhüningen’ from Hwy A5 or exit ‘Badischer Bahnhof/Basel Ost’ from Hwy A35. Self-parking or valet parking is available at the car park of the fairgrounds (allowed maximum height of 2m).

Other Options

Pullman Basel Europe
Rail:

  • The main train station ‘SBB Basel’ is approximately 2km away: take the tram No. 16 Bhfeingang Gundeldingen to Clarastrasse (duration 15-17 minutes, departure every X minutes)
  • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram No. 6 or No. 16 to Clarastrasse (duration 4 minutes, departure every 8 minutes)

Swissôtel Basel
Rail:

  • The main train station ‘SBB Basel’ is approximately 2km away: take the tram Nr. 1 or Nr. 2 to Messeplatz Basel
  • the train station ‘Basel Badischer Bahnhof’ is approximately 1km away: take the tram Nr. 6 to Messeplatz Basel

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (7,7%)

* 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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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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