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Parenteral Drug Association Connecting People, Science and Regulation ®

Extractables & Leachables

Including: Important Regulatory Updates – Case Study Section: Selection of Toxikon’s most interesting Case Studies, presented over the last 10 years!
Nov 29 - Nov 30, 2018 |
Nov 30, 2018 |
MELIÁ SEVILLA | Seville, Spain
  • Education
  • Europe
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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...).

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

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

Faculty

John Iannone, Principal Consultant, 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.


Piet Christiaens, PhD, Scientific Director, Nelson Labs NV (formerly Toxikon Europe)
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 at Nelson Labs Europe (formerly Toxikon Europe) where he develops 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.


Dennis Jenke, PhD, Chief Executive Scientist, 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.

Thursday, 29 November 2018

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, 30 November 2018

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

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

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

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

MELIÁ SEVILLA
Calle Dr. Pedro de Castro 1
41004 Sevilla
Spain
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 26th September 2018

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*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)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.

Parking

Parking available upon request at the registration desk.

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4498

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