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Workshop Extractables and Leachables and Container Closure Integrity Testing!

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In recent years, regulatory requirements for assessing substances that may leach into drug products over their lifecycle have become increasingly stringent. Materials used in packaging can release chemicals that migrate into pharmaceuticals, potentially affecting patient safety, drug stability, and efficacy. Ensuring that container-closure systems do not introduce harmful substances is critical for compliance and product integrity.

Join our workshop on pharmaceutical packaging testing on May 20th in Limburg to gain the knowledge and tools needed to develop a successful testing strategy that safeguards your products and meets regulatory expectations.

During this workshop you will learn: 

  • Regulatory requirements and expectations on E&L
  • How to prepare a successful E&L study
  • Practical approaches for E&L testing
  • Evaluation of E&L data
  • Toxicological assessment
  • E&L testing for single-use systems
  • Container Closure Integrity Testing (CCIT)

You can see the full agenda here: Agenda

Extractables and Leachables and Container Closure Integrity Testing. This workshop will take place in Limburg. It is not possible to join this workshop online. 

Please do not use any special characters. If you experience technical issues while registering for the workshop, please email us at PharmaTesting@bpt.eurofinseu.com.

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Thank you for registering for Workshop Extractables and Leachables!

Speaker: Daniele Zarini, Project Manager at Eurofins BioPharma Product Testing Italy

Short CV: Daniele earned a bachelor's and master's degree in industrial biotechnology (bioinformatics field) in 2014 and 2016, respectively, and he started working as a toxicologist in the electronic cigarette industry from 2017 to 2021. Daniele joined Eurofins BioPharma Product Testing Italy in 2021 as a toxicologist in the E&L sector of the pharmaceutical industry, holding also the role of project manager (E&L, biological, chemicals). Daniele is currently team leader for the pharma consulting group.

 

Speaker: Eleonora Lostaglio, Consultant at Eurofins BioPharma Product Testing Italy

Short CV: With a degree in Toxicology and Safety Assessment from Milan, she joined Eurofins BioPharma Product Testing Italy in 2020 after gaining experience in in silico toxicology research and in the pharmaceutical industry as Quality Assurance. Initially working as a toxicologist at Eurofins, Eleonora currently holds the position of Project Manager at Eurofins Regulatory & Consultancy Services Italy, with a particular focus on the pharmaceutical area. In this role, she manages complex projects, coordinates multidisciplinary teams, and supports companies in complying with regulations and safety standards.

     

Speaker: Francesco Tessari, Technical business manager at Eurofins BioPharma Product Testing Italy

Short CV: Francesco graduated in pharmaceutical chemistry and technologies with a focus on analytical chemistry and method development. He started working in Johnson & Johnson as QC technician. He then moved to Cambridge (UK) working for 4 years in a C.R.O. as an analytical specialist and study director specialised in analytical method development and validation. In 2021 he started working as a Project Leader for the E&L department in Eurofins BioPharma Product Testing Italy providing his expertise on chemical screenings and analytical techniques. He is currently supporting the E&L department as a technical advisor in order to provide Eurofins approach on E&L studies and upcoming regulatory challenges.

 

Speaker: Francesca Calò, Project Leader at Eurofins BioPharma Product Testing Italy

Short CV: Francesca Calò holds the position of Project Leader E&L at Eurofins BioPharma Product Testing Italy. Francesca leads several projects and is responsible for designing technical solutions to improve workflow in various scenarios, ensuring high-quality standards. She is also responsible for presenting data to stakeholders. She earned an innovative PhD with industrial characterisation in Chemistry from the Department of Biological and Environmental Sciences and Technologies at the University of Salento (IT) and a Master's degree in Medical Biotechnology and Nanobiotechnology in collaboration with Cranfield University (UK), where she conducted experimental thesis research in analytical chemistry.

 

     

Speaker: Matilde Ciaroni, Consultant at Eurofins BioPharma Product Testing Italy

Short CV: Matilde Ciaroni, has been working as a toxicologist consultant in the Eurofins BPT Consulting Europe, biopharma team since 2020 after graduating in Safety Assessment of Xenobiotics and Biotechnological products at the University of Milan. She deals with toxicological assessments on extractables and leachables studies.

 

Speaker: Simone Carrara, Business Unit Manager at Eurofins BioPharma Product Testing Italy

Short CV: Simone joined Eurofins BioPharma Product Testing Italy in 2012. He is the Business Unit Manager of the Extractables & Leachables and Packaging Testing Department. He is also E&L Senior Scientific Director in Eurofins. Starting from a biotechnology degree at the University of Milan in 2005, he built his experience as a bio-analytical researcher through LC/MS method developing for pharmacokinetics analysis and ADME profiling. He has led projects in a wide range of areas of the analytical chemistry including method developing/validation by LC/MS-GC/MS and drug product impurities characterisation. In the last 10 years, his job was focused on extractables & leachables testing to support drug-manufacturing companies in the fulfillment of the regulatory requirements.

     

 

The date and place:

Date: 20th of May 2025
Time: 9.00am – 5.00pm
Location: Dom Hotel Limburg, Limburg, Germany
Language: English
Cost: The seminar day is free of charge.

Travel Information:
You can find all necessary travel informations on the hotels website - no matter if you arrive by train, plane or (electric) car. 

 

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