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Leachables & Extractables - Testing & Assessment

2014, May 14 - 15

Pharmaceutical » Training

Introduction to Plastics
Physical and chemical characteristics
Different types of additives in plastics

Regulatory Requirements for Extractables / Leachables Testing
Why should Extractables & Leachables be assessed?
Regulatory requirements of EMA and US-FDA
Compendial requirements and foodstuff regulations
PQRI and other recommendations for Safety Thresholds and Best Practices for Extractables & Leachables testing

Extractables and Leachables Testing in Packaging Material
Why – Regulatory requirements of FDA and EMEA
What – Change in primary and secondary packaging material or labels
How – Global and tailored approaches

GMP-compliant Approach to a Process Specific
Extractable / Leachable Study
Key regulatory guidances mentioning packaging considerations
Discussion of the container closure guidance
General approach to extractable / leachable studies (pre-screening, method development and validation, leachable study in stability samples)
Sources of extractables/leachables
Case Studies

Routine Extractables Testing in Quality Control
Batch-to-batch consistency in composition and purity of packaging components
Acceptance criteria for extractables profiles
Quality agreements with suppliers

Extractables & Leachables: A Pragmatic Approach
In-Process Materials with Product Contact
Elastomeric Drug Product Stoppers
Experience with Regulatory Agencies
Questions, Comments

L&E Strategies in Practice
How to design a reasonable E&L study („to do enough but not too much“)
The translation of regulatory requirements into analytical lab work
The evaluation of extractables data and consequences to leachables studies
How to outsource E&L studies
Illustrative examples

Extractables from Glass
Glass composition
Type of extractables from glass
Risk evaluation of glass extractables
Concepts to avoid extractables from glass

Potential Extractables from Elastomers
General definition of rubber
Composition of elastomers used for pharmaceutical applications
Discussion material composition and extractables (Potential extractable list)
Approaches to minimize extractables/leachables from elastomeric closures

Leachables during Manufacturing
Bag-filter-assemblies and other polymer-based materials in the manufacturing process
Finding the right test approach under consideration of critical success factors for the pharma/biotech industry such as cost efficiency, time-to-market and regulatory compliance
Model solvent testing versus product and process specific testing
Evaluation of the test results

Printing Inks as Potential Sources of Extractables & Leachables
Introduction and basics of printing techniques
Composition & chemistry of ink systems (“the ink manufacturer’s toolbox”)
Possible interactions of printing ink systems with the packaging material and the drug formulation
Illustrative examples of extractables from printing
Relevance of ink components as leachables.



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