Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

Instructor: Armin Hauk
Product ID: 704340
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.

Why Should You Attend:

This webinar will focus on learning and understanding the concept of Extractables and Leachables investigation in pharmaceutical development and QC based on regulatory requirements, national and international guidelines and recommendations. The course will give guidance on how to develop E&L studies in a reasonable and pragmatic way and to avoid pitfalls, to assess Extractables data and to derive lists of relevant Leachables. The similarities and differences of E&L investigations for pharmaceutical contact materials like container closures systems, single use systems in production and also for medical devices will be discussed.

Areas Covered in the Webinar:

  • Introduction into the field of E&L for pharmaceutical container closure systems (CCS), process contact materials and single use systems (SUS)
  • The regulatory background (in US and EU)
  • How to design reasonable E&L studies for CCS and SUS
  • The assessment of E&L data
  • Illustrative examples of E&L studies and their assessment

Who Will Benefit:

Personnel of pharmaceutical companies and their suppliers, in particular those responsible for:

  • Qualification of Extractables and Leachables
  • E&L testing (practically)
  • Quality control of packaging materials
  • Process development and qualification

Instructor Profile:

Armin Hauk-Intertek studied environmental chemistry and parallel to his PhD he conducted a 5 year research work in the field of polymer combustion chemistry. He joined the central analytical department of the former Ciba-Geigy Inc. in 1995. Since 2000, Dr. Hauk-Intertek has been the head of the trace analysis group, the GLP testing facility, the GMP quality control laboratory in Basle, and since 2013, he has been the lead senior consultant for Extractables and Leacheables. He is responsible for organic trace and ultra-trace analysis, special analytics for registration, migration studies, extractable and leachable studies for pharmaceutical packaging, for GMP quality control analysis and stability tests. He is ‘responsible person’ according to the Swiss Pharma Law (HMG) and member of the EDQM Working Group of the Council of Europe working on plastic containers for pharmaceutical use.

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