Extractables & Leachables - Spring Edition

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

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