Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Extractables and Leachables Training Course

Nov 08 - Nov 09, 2018 |
Nov 09, 2018 |
Regent Taipei | Taipei, Taiwan
  • Education
  • Asia-Pacific
Add event to: ICal Outlook Google Calendar
The 2018 PDA Extractables and Leachables Training Course will cover all aspects of extractables and leachables, including:
  • Understanding the Polymers Used in the Manufacture of Pharmaceutical Containers and Closures
  • Understanding Glass as an Important Material Used in the Manufacture of Primary Packaging of Small Volume Parenterals
  • The Mechanism of Leaching
  • Helicopter View on the recent and Upcoming Changes to the US Pharmacopoeia (USP) 
  • How to Perform a Safety Evaluation: Risk Assessment on Extractables and Leachables
  • How to Set-up Extractable and Leachable Studies
  • Analytical Techniques to Perform Extractables and Leachables Research
  • E/L Testing for a Small Volume Parenterals (Liquid and LYO applications)
  • E/L testing for Disposable and Single-Use Systems in Bioproduction

Thursday, 8-November

8:00 – 17:00
Registration Open

9:00 – 12:00

Introduction on Extractables and Leachables

  • What is the importance of a good E/L-qualification
  • Historical cases of leachables, impacting the quality or the safety of a drug product
  • Global regulatory requirements (FDA, EMA, etc.) for primary packaging

Understanding the Polymers Used in the Manufacture of Pharmaceutical Containers and Closures

  • Types of polymers: examples in medical/pharmaceutical use
  • Understanding the composition of polymers
  • Making the distinction between compounds that are intentionally added to a material/polymer and not intentionally added substances

Understanding Glass as an Important Material Used in the Manufacture of Primary Packaging of Small Volume Parenterals

  • Types of glass and their composition
  • Additives added to glass, role and function
  • Glass: the manufacturing process
  • The issues with glass in parenteral applications
  • Glass delamination and other quality issues with glass

12:00 – 13:00
Networking Luncheon

13:00 – 17:00

The Mechanism of Leaching

  • What are the physicochemical parameters to be considered when trying to understand polymer migration
  • How do leachables move through a polymer, the diffusion model
  • Special cases in migration

Helicopter View on the recent and Upcoming Changes to the US Pharmacopoeia (USP)

  • USP <661> Plastic Packaging Systems and their Materials of Construction
  • USP <661.1> Materials of Construction
  • USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
  • USP <665> Polymeric Materials in Manufacturing of (Bio)Pharmaceutical Drug Products
  • USP <1661> Evaluation of Plastic Packaging
  • USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
  • USP <1664> Assessment of Leachables Associated with Pharmaceutical Packaging/Delivery Systems

How to Perform a Safety Evaluation: Risk Assessment on Extractables and Leachables

  • Toxicology 101
  • EMA guideline on genotoxic impurities
  • ICH M7 (DNA reactive Impurities) and it’s suggested staged approach.
  • The Threshold concept of PQRI (OINDP and PDP/ODP)
  • Examples

Friday, 9-November

8:00 – 17:00
Registration Open

9:00 – 12:00

How to Set-up Extractable and Leachable Studies

  • Designing extraction studies that are compliant with USP <1663>
  • Selecting the right conditions for extraction
  • How to select the right compounds to monitor in a leachable study?
  • Designing a leachable study compliant with USP <1664>

Analytical Techniques to Perform Extractables and 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:

E/L Testing for a Small Volume Parenterals (Liquid and LYO applications)

  • 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 and leachable studies for a pre-filled syringe
  • Primary packaging for the lyophilized drug product – modus of interaction with the DP

12:00 – 13:00
Networking Luncheon

13:00 – 17:00

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 and BPOG recommendations, and how they can be implemented in the study design
  • Performing e/l studies on filters: potential approaches

Case Study Section

  • Case study examples for primary packaging: pre-filed syringes, lyophilized drug product containers, blow-fill-seal applications, large volume parenterals, etc.
  • Case study examples of the impact on secondary packaging: labels, printing inks, carton boxes, etc.
  • Case study examples of single-use systems: bags, filters, tubing

Standard

Member

$675

Nonmember

$855


Government/Health Authority/Academic

Member

$495

Nonmember*

$495


Student Member

Member

$380

Nonmember*

$425


Young Professional Member

Member

$450

All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

You must be a member to take advantage of this rate.

REFUND FOR COURSES: If your written request is received by October 19, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: moir@pda.org

Piet Christiaens, PhD, Scientific Director, Nelson Labs Europe
Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4546

Directions