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2019 ParPack

Extractables & Leachables - Spring Edition

Mar 21 - Mar 22, 2019
Venice, Italy

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, 21 March 2019

    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, 22 March 2019 

    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

  • Friday, 22 March 2019

    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
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Hilton Molino Stucky Venice

Giudecca, 810
Venice, Italy
Phone: +39 041 272 3311

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Hilton Molino Stucky Venice
  • Accommodations

    Hilton Molino Stucky Venice
    Giudecca, 810
    30133 Venice
    Italy
    Tel: +39 041 272 3311
    Hotel Website

    Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice. Just 30 minutes from the airport, we also offer a shuttle boat service to the city center. With 379 rooms and suites, the largest Congress Center and the second largest spa in Venice, a collection of bars and restaurants and a stunning rooftop pool, our hotel is the perfect location for your stay in Venice.

    The comfort of their guests is a commitment reflected in the quality and finishes of their 379 rooms. Designed to be a place to unwind, all the rooms offer elegant amenities, spacious marble bathrooms and comfortable beds. Treat yourself with an upgrade and enjoy breathtaking views or access to the Executive Lounge.

    Experience a real taste of the Mediterranean in the elegant Aromi restaurant or savor the authentic flavors of Venetian cuisine at Bacaromi. Spoil yourself with Nutella desserts or relax with a coffee at the lounge. Sip a cocktail Skyline Rooftop Bar enjoying outstanding views over Venice.

    PDA Europe has reserved a limited number of rooms until the 19th December 2018.
    Book Your Room for the PDA Group Rate

    Single Room € 209 per night*
    Double Room € 239 per night*

    *Rates are per room and night, including the following services and benefits free of charge:
    • Buffet Breakfast in the restaurant
    • VAT, Taxes and Service Charge will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Venice Marco Polo Airport – VCE
Airport Phone: +39 041 260 9260

By Car

Distance: 17 km

Airport shuttle service
Hotel Station: Giudecca Stucky

  • Public Boat: approx. €15 per passenger (one way)
  • Public Bus: approx. €8 per passenger (one way)
  • Public Taxi: approx. €35 per passenger (one way)
Water Taxi Info

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT (22%)

* 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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