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European Workshop on Extractables, Leachables and Food Contact Materials Testing June 11-12, 2018 | Lisbon, Portugal

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Page 1: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

European Workshop on Extractables, Leachables and Food Contact Materials Testing

June 11-12, 2018 | Lisbon, Portugal

Page 2: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

MONDAY, JUNE 11

13:00 R E G I S T R A T I O N A N D L U N C H

14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European Business Development Manager, Chemical Materials, Waters Corporation

14:15 Technology Overview for Extractables and Leachables and Migration Testing Baiba Čabovska Ph.D., Business Development Manager, Chemical Materials Business, Waters Corporation

15:00 Is High Resolution Mass Spectrometry a Swiss Army Knife in Extractables Studies? A Suppliers Perspective Dr. Roberto Menzel Sartorius Stedim Biotech GmbH, Germany

15:45 C O F F E E B R E A K

16:15 Identification of Non-Intentionally Added Substances (NIAS) in Food Contact Materials using APGC-Xevo™ G2-XS QTof and UNIFI™ Software Nicola Dreolin Application Scientist, Waters Corporation

17:00 Using the UNIFI Screening Platform Solution for Identification, Structural Elucidation and Quantitation of Unknowns in Extractables and Leachables Analysis Dr. Christoph Thomas LC/MS Senior Application Specialist, Waters Corporation

17:45 Wrap up Dr. Falk-Thilo Ferse European Business Development Manager, Chemical Materials, Waters Corporation

18:00 Closing day 1

19:00 S O C I A L E V E N T City Tour of Lisbon At the end of the day, we will take some time to relax and visit the city centre. The visit will end near the docks and the famous bridge “Ponte 25 de Abril” where we will share a nice dinner on the terrace in front of the Tagus River.

23:00 E N D O F T H E D I N N E R Back to the hotel

Page 3: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

TUESDAY, JUNE 12

Food Contact Materials Session Chairman: Dr. Falk-Thilo Ferse

08:30 Welcome Dr. Falk-Thilo Ferse European Business Development Manager, Chemical Materials, Waters Corporation

08:40 Safety Assessment of FCM. A Case Study of a Borderline Product: Baby BIBs Fatima Poças Professor of Packaging at Biotechnology College the Portuguese Catholic University, Porto

09:20 Elucidation of Unknowns and NIAS Migrants by HRMS Professor Cristina Nerín Department of Analytical Chemistry, University of Zaragoza, Spain

10:00 C O F F E E B R E A K

10:30 Addressing Challenges in Analyses of Food Contact Materials Round Table Discussion

11:30 Migration of NIAS from Food Contact Materials (FCM) – A Regulatory and Analytical Perspective Dr. Ioan Paraschiv Regulatory Affairs Manager, knoell, The Netherlands

12:10 Coatings for Food Contact Materials — NIAS and Strategy for their Analysis Sarah Dubail Senior Regulatory Analyst, Valspar, France

12:50 Wrap up Dr. Falk-Thilo Ferse European Business Development Manager, Chemical Materials, Waters Corporation

13:00 L U N C H

14:00 E N D O F T H E M E E T I N G

Extractables and Leachables Session Chairman: Baiba Čabovska

Welcome Baiba Čabovska Ph.D., Business Development Manager, Chemical Materials Business, Waters Corporation

Extractables and Leachables: What Are They, Where Do They Come From and How Do We Identify Them ? Dr. Andrew Feilden Chemistry Operations Director, Smithers Rapra, UK

Milestones in Organizing E&L Assessments for Finished Packaging Dr. Andreas Nixdorf GE, Business Development Manager Extractables & Leachables Testing, SGS Life Science, Germany

C O F F E E B R E A K

Addressing Challenges in Extractables and Leachables Analysis Round Table Discussion

Strategies and Tools for the Toxicological Evaluation of Extractables and Leachables in Drug Products and its Analytical Implications Reinhard Stidl Associate Director, Lead Toxicological Risk Assessments, Shire, Austria

A UNIFI Workflow for Extractables Studies using Ion Mobility-Mass Spectrometry Ewan Pickard Principal Scientist, Mass Spectrometry, Smithers Rapra, United Kingdom

Wrap up Dr. Falk-Thilo Ferse European Business Development Manager, Chemical Materials, Waters Corporation

L U N C H

E N D O F T H E M E E T I N G

Page 4: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

SPEAKERS’ BACKGROUND AND ABSTRACTS

Dr. Falk-Thilo Ferse European Business Development Manager, Chemical Materials, Waters Corporation

Falk-Thilo Ferse has more than 15 years experience in the field of Chromatography and Mass Spectrometry. He had worked at Waters in several sales positions in Germany, before he became trainer in the field of UPLC®. Then he changed into the marketing and has become a European Business Development Manager. In July 2014 he changed into the marketing and became a European Business Development Manager, where he still works to this day.

Baiba Čabovska, Ph.D. Business Development Manager, Chemical Materials Business, Waters Corporation

Baiba Čabovska currently is a senior business development manager in chemicals and materials market for Waters Technologies based in Milford, MA. She is responsible for customer collaborations and addressing customer needs in materials characterization with a special focus on extractables and migration testing. Prior to joining Waters, Baiba worked at Mannkind Corporation doing analytical development for insulin based products as well as extractables testing for a dry powder inhalation device.

Technology Overview for Extractables and Leachables and Migration Testing.

Packaging, equipment and device characterization is a requirement in many industries: from pharmaceutical to food, from cosmetics to biotechnology. Possible extractables include impurities from the raw materials, degradations products, cross-reaction products. Many of these substances could be potentially harmful to human health; therefore a thorough testing is required. The characterization may include verification of target compounds, elucidation for unknown peaks, quantitation for the migration levels and other analytics. How can Waters product portfolio assist with these challenges in your lab?

Dr. Roberto Menzel Sartorius Stedim Biotech GmbH, Germany

Roberto Menzel studied chemistry at the Friedrich-Schiller-University in Jena and received his PhD in the group of Prof. Beckert in 2012. After university, he started as assistant editor in the natural science book section at Wiley VCH, Weinheim. In 2014, he moved back to Jena to take over the position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific. Since 2015, Roberto Menzel is heading the Extractables analysis laboratory at Sartorius Stedim Biotech in Göttingen. In this position he is responsible for material and product qualification studies for single use systems and components used in the biopharmaceutical industry such as sterile filters, bags or tubings.

Is High Resolution Mass Spectrometry a Swiss Army Knife in Extractables Studies? A Suppliers Perspective.

Sartorius Stedim Biotech has unique and long track of record in providing comprehensive extractables data for single use systems (SUS) to our customers in the biopharmaceutical industry. Regulatory authorities such as the FDA request these data during material qualification for a biopharmaceutical processes. For biopharmaceutical manufacturers it is mandatory to know all compounds of a single use (SU) component or system that might into a process stream and potentially influence product quality or - at the worst - can affect patient safety. To obtain such an extractable profile of a SU component or system it is extracted under defined exaggerated laboratory conditions. Extracts are analyzed using a variety, orthogonal analytical techniques. Commonly, gas and liquid chromatography is used to separate and optical or mass selective detectors are used to identify and quantitatively detect individual extractables.

Ultra-Performance Liquid Chromatography (UPLC™) coupled to a hybrid mass spectrometer such as a quadrupole time-of-flight (QTof) has gained tremendous attention in recent years for the investigation of individual substances. Target, suspect and non-target screening are valuable features to identify and quantify known or detect unknown extractables. Different ionization techniques can be used (ESI, APCI) if one analyte might not be sufficiently ionized by one technique. An elaborated software together with a huge database helps with structure elucidation of unknowns. Is it that easy?

The presentation will focus on the remarkable potential a current LC-HRMS systems truly offers but also an overview is given about challenges users might encounter. For example, contaminations are addressed which are one problem because of the high sensitivity of the instruments. A LC-HRMS method using several targets for quantification will be presented. A procedure of how to interpret results is given together with the approach on how to handle unknowns exemplified by our recent findings. Shortly, an overview is provided about an end-user experience in using a LC-HRMS system in the investigation of extractables from single-use systems.

Page 5: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

Nicola Dreolin, MSc Application Scientist, Waters Corporation

Nicola Dreolin is an LCMS Analyst at Hall Analytical Laboratories (Manchester, UK), specialised in the analysis of Extractables and Leachables, Pharmaceuticals, Tobacco and E-Cigarette products, Cosmetics, Agrochemicals and Persistent Organic Pollutants. He graduated from the University of Udine (Italy) with a Bachelor degree in Food Science and Technology, and a Master degree in Control and Management of Food Quality. During his studies he worked as Research Analyst at the Aragón Institute for Engineering Research (Zaragoza, Spain), where was employed in the development and validation of LC-MS and GC-MS methods for the analysis of harmful chemicals in various matrices. Before moving to Hall Analytical he worked at Waters Corporation, UK headquarter, as Application Scientist within the Scientific Operations team. He is member of the Italian Mass Spectrometry Society.

Identification of Non-Intentionally Added Substances (NIAS) in Food Contact Materials using APGC-Xevo G2-XS QTof and UNIFI Software.

Identifying unknown compounds in food contact materials is usually a challenging process. The potential of Atmospheric Pressure Gas Chromatography (APGC) couple with a quadrupole/time of flight mass spectrometer and the UNIFI scientific information system has been investigated and applied to the structure elucidation of Non-Intentionally Added Substances (NIAS) in a novel starch-based biopolymer intended for food grade. Significant components were located using binary comparison to an extracted solvent blank, followed by the analysis of the accurate masses and fragmentation pathways of precursor ions. Three case-studies are illustrated.

A comparative study with Electron Ionization (EI) demonstrated that the two ion sources considered are complementary when the compounds of interest are described in commercially available libraries, whereas APGC-high resolution mass spectrometry is particularly advantageous for the elucidation of volatile and semi-volatiles not listed in the libraries, or for those at trace or ultra-trace levels. APGC, together with UNIFI componentization, eases the burden of data interpretation, reducing potential false-positive assignments and correcting possible erroneous identifications.

Dr. Christoph Thomas LC/MS Senior Application Specialist, Waters Corporation

Christoph Thomas is a Senior Applications Specialist from the Central Europe Customer Success Team based in Eschborn, Germany. He has more than 19 years experience in the field of Chromatography and Mass Spectrometry and is familiar with several application areas using Quadrupole and Tof instruments. Within the last 6 years his projects were mainly focused on the UNIFI Screening Platform Solution in environmental screening, toxicology screening, metabolite identification and also in the field of extractables and leacheables.

Using the UNIFI Screening Platform Solution for Identification, Structural Elucidation and Quantitation of Unknowns in Extractables and Leachables Analysis.

The characterization of packaging, food contact materials, medical devices and many other consumables is becoming more and more important due to ever increasing global regulations. The characterization of extractables not only includes targeted screening, but is also looking for “What else is in the sample?”. We will have a brief look on an example workflow reviewing HRMS data for targeted and suspected and also non-targeted screening.

However, it is more challenging looking at impurities or additional degradants and to deal with the identification and do also the quantitation of unknowns. Due to the fact that there are no standards for calibration available a critical aspect is the usage of a known surrogate standard. Furthermore unknowns from different categories can have a broad range of response factors. A possible approach for the quantitation of unknowns using UNIFI will be discussed.

Fatima Poças Professor of Packaging at Biotechnology College the Portuguese Catholic University, Porto

BSc Chemical Engineering, MSc in Packaging, PhD in Biotechnology – Food Engineering and Science. Senior Researcher and Prof. (eq.) at Escola de Biotecnologia Universidade Católica Portuguesa at Porto. Coordination of the packaging laboratory since 1990 and Centre for Food Quality and Safety 2013. Development, coordination and teaching food packaging courses at undergraduate and master level since 1992. Works in the field of mass transfer processes applied to safety and quality of packaged food, in particular on chemical hazards and migration from packaging systems and on consumer exposure estimation. She integrated the team of several research projects national and European and led 2 national research projects. Represents Portugal in the European Network of Food Contact Materials Laboratories since 2004 and is member of EFSA Panel CEF since 2012.

Safety Assessment of FCM. A Case Study of a Borderline Product: Baby BIBs.

Baby BIBs are food contact materials although often industry tend to classify then as clothing or baby toys. This has a major impact on the criteria and protocols for safety assessment and control. An overview on legislation and recent developments on assessment protocols as applied to FCM will be discussed. A case study on a short survey performed at European level will be presented. Examples of identification and quantification of migrants from these borderline products will be discussed.

Page 6: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

SPEAKERS’ BACKGROUND AND ABSTRACTS

Dr. Andrew Feilden Chemistry Operations Director, Smithers Rapra, United Kingdom

Dr Andrew Feilden is the chemistry operations director at Smithers Rapra and Smithers Pira. He leads the chemistry group at the Shawbury site in the UK. The Shawbury site carries out extractable and leachable testing, GPC analysis and food contact testing. He has delivered numerous international podium presentations on Extractables and leachables.

Andrew has been with Smithers for over 7 years, prior to that he worked for AstraZeneca, specialising in Extractables and Leachables. He has a degree and D Phil from the university of York, is a Fellow of the Royal Society of Chemistry and is a Scientific advisor to IPAC-RS

Extractables and Leachables: What Are They, Where Do They Come From and How Do We Identify Them?

Professor Cristina Nerín Department of Analytical Chemistry, University of Zaragoza, Spain

Full Professor at the University of Zaragoza (Spain), PhD in Analytical Chemistry, Master in Science (Analytical Chemistry) and Degree in Chemistry at the University of Zaragoza (Spain) Director of the Research Group GUIA at the University of Zaragoza and Director of the Master in Environmental Engineering at the University of Zaragoza from 1990 to 2012. Author of more than 300 Scientific Publications included in the Citation Index, Director of 37 PhD Thesis (5 more are in process). Principal Investigator of more than 200 Research Projects in both Competitive calls and also R&D&I with Industry Inventor in seven International Patents dealing with active packaging and in one Inter-national Patent on Intelligent Packaging. All of them are in exploitation (market).

Six Research Awards received. Participant in more than 140 International Conferences and Professor of several International Courses in Europe, Asia and South-America. Organizing Committee and Chairwomen of several Inter-national Symposiums (SLIM, MATBIM, ILSI, Int. Symp. On Environmental and Anal. Chem …)

Member of WG Recycling in CEF Panel in EFSA since 2010. Member of the scientific Panel in AECOSAN (Spanish Food Safety, Nutrition and Social Affairs Agency) in the period 2010-2015. Executive Editor of the journal Packaging Technology and Science Evaluator of R&D&I Projects at National and International level (EU-VII Frame Program, Chile, Brasil, The Netherlands, Austria, Belgium, Portugal, Argentina, France, Saudi Arabia, USA, Israel, etc.). Eval-uator of PhD Thesis at National and International level. Consulting member of several Committees and Institutional Boards. Referee of the most relevant Scientific Journals in the field of Analytical Chemistry, Materials Science, Food Chemistry, Food Technology, Food Packaging, Food Science, Environmental, etc.

Invited as an expert to several International Workshops. Invited as speaker of Plenary Lectures in more than 50 Inter-national Conferences. Main research areas of interest: 1. - Packaging topics, mainly food packaging (food packaging interactions, raw and recycled materials, products, migration, active packaging, intelligent packaging, adhesives, printing inks, varnishes, new materials and new developments, NIAS…)

Elucidation of Unknowns and NIAS Migrants by HRMS.

Page 7: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

Dr. Andreas Nixdorf GE, Business Development Manager Extractables & Leachables Testing, SGS Life Science, Germany

Andreas studied organic chemistry at the University of Bielefeld in Germany with the main focus on mass spectrometry and computational chemistry. Since the date of his PhD/doctorate in 1997, he worked in different scientific and managerial positions in Life Science industry prior he proceeds with his carrier at SGS in 2007. From 2007 to 2010 he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services at SGS in 2008 and got his current position in 2010. Andreas applies technical and regulatory knowledge, scientific experience and expert judgment to address solutions for a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from pharmaceutical and medical industry. With over 20 years’ experience in Life Science segment he is a frequent speaker at events and international conferences (PDA, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Concept Heidelberg, Chinese Medical Device Association and others) in the fields of Medical Device, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory controlled industries are challenged by on-going regulatory systems. Changes must be set in practice and cross-functional teams with different functional expertise must be organized to work toward a common goal. Andreas wants to motivate experts from Life Industry or organizations working together to realize or achieve a better and effective cross departmental collaboration in order to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Milestones in Organizing E&L Assessments for Finished Packaging.

The pharmaceutical industry is required by official bodies to demonstrate that no toxic or harmful substances migrate from packaging materials into a drug during its expected product shelf life. Packaging materials have been in the focus of safety investigations for a long time as the contact time between drug product and packaging material is rather long. Extractables are chemicals that can migrate from a drug product closure or container and have the potential for contaminating the dosage form. Under certain exaggerated solvent, temperature and time conditions, an extractable may be generated through an interaction with the closure system. Leachables, a subset of extractables, are chemical species that migrate from packaging under normal conditions of use or during stability studies. Leachables have the potential to interfere with drug product assays or medical diagnostic tests, change the pH level, increase a drug’s toxicity, or raise the impurity level of a drug to an unacceptable range. It is also critical from a due diligence standpoint to understand what external species may have migrated into the drug product itself.

Extractable screening during safety studies is an important part in choosing the appropriate container or closure for a dosage form and can minimize the time and expense needed for future suitability studies. Early assessment of extractables and leachables can eliminate potential late-stage packaging interactions and also help reduce exposure to regulatory and product-related risks. The presentation guides you through the organizational milestones of an E&L assessment.

Dr. Ioan Paraschiv Regulatory Affairs Manager, knoell, The Netherlands

Dr. Ioan Paraschiv is a Regulatory Affairs Manager at Knoell NL B.V. in the Netherlands. He is advising on the registration of food contact materials (FCM) in the EU and the US and is also supporting knoell’s clients in the preparation of registration dossiers for the industrial chemicals in Europe (REACh).

He received his Ph.D. degree in Physical-Organic Chemistry from Wageningen University in the Netherlands, in January 2007. His thesis focused on the synthesis, characterization and opto-electronic properties of H-bond stabilized columnar discotic liquid crystals.

Following his Ph.D. he has worked with several Contract Research Organizations (CROs) in The Netherlands, Scotland and Romania, with focus on solid state chemistry studies applied to small molecule pharmaceuticals, as well as on registration of agro-chemicals (PPP) in the EU.

During the last 6 years he has been providing scientific and regulatory support to customers on the analytical and physical chemistry sections of REACh/ FCM registration dossiers.

Migration of NIAS from Food Contact Materials (FCM) — A Regulatory and Analytical Perspective.

• Current regulatory landscape of food contact materials (FCM)• Migration studies: when, what, how, and thereafter ?• Relevance of NIAS - identification and quantification – an analytical perspective • Roles and responsibilities of different stakeholders in the FCM supply chain with respect to NIAS

Page 8: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

SPEAKERS’ BACKGROUND AND ABSTRACTS

Reinhard Stidl Associate Director - Lead Toxicological Risk Assessments, Shire, Austria

Dr. Reinhard Stidl is currently still heading the group Toxicological Risk Assessments at Shire, but is leaving the company end of June 2018. Reinhard holds a Master in Chemistry (University of Vienna, 2002), a PhD in Chemistry (University of Vienna, 2007), a Master of Advanced Studies Toxicology (Medical University of Vienna, 2007) and is EUROTOX registered toxicologist (ERT). He worked as Scientist and Sr. Manager at Baxter and later Baxalta, since 2016 at Shire as Associate Director, where he led a team of 5 trained toxicologists at maximum. Dr. Stidl has more than 10 years of experience in safety assessment in the context of pharmaceuticals, since 2010 with strong focus on extractables and leachables (E&L). In the context of E&L, he was responsible for the global design and refinement of the global safety assessment strategy within Baxter, Baxalta and Shire. There, he pioneered the development of methods and processes to evaluate the safety impact of E&L on patients, including in silico tools and several decision trees which are today a systematic aid to qualify large numbers of extractables. In the near future, Dr. Stidl will provide his services to clients from pharmaceutical, food, polymer and cosmetic industries via the consulting office Safetree.

Strategies and Tools for the Toxicological Evaluation of Extractables and Leachables in Drug Products and its Analytical Implications.

The presentation aims to give an overview of the scientific principles of the toxicological risk assessment for impurities, specifically chemical which may migrate from polymer materials to pharmaceutical intermediates and final drug products. The principles used for extractables and leachables (term specifically used for pharmaceuticals) are also often valid and even inspired by strategies how to qualify non-intentionally added substances (NIAS) in foodstuffs. Generic and substance specific safety thresholds can be derived, which may have directly influence on the design of analytical methods. Generic safety thresholds are mainly thresholds of toxicological concern (TTC) which relate to a group of compounds (mutagenic impurities, sensitizers, Cramer classes). Today, in silico tools are emerging to play a major role in the classification of substances only based on their chemical structure and similarity to compounds with known toxicity. These modern tools facilitate and accelerate the assessment of a large number of chemicals / potential impurities which are identified by modern and sensitive analytical methods. The team work of analytical experts and toxicologists allows to set evaluation thresholds of state-of-the-art methods and interpret the analytical data for relevance. The presentation also contains details on regulations and case studies of toxicological risk assessments.

Sarah Dubail Senior Regulatory Analyst - Valspar, France

Sarah Dubail has been Regulatory Affairs Specialist at Sherwin-Williams, Packaging coatings division, for one year. Formerly she was the Manager of the European Analytical lab of Valspar for 13 years, responsible for analyzing migration from packaging coatings and providing analytical data to do risk assessments. She has experience in food contact regulations and analytical methods for the determination of FCM migrants including NIAS. She represents her company at Trade association level, and recently contributed to coating industry migration and NIAS guidelines.

Coatings for Food Contact Materials — NIAS and Strategy for their Analysis.

Canned food has many advantages, among them the reduction of food waste, protection against microbiological contamination, a long shelf life, without the need for preserving additives. This requires high performance coatings on the internal (food contact) side of the cans, to protect the food from the metal and the metal from aggressive foodstuffs to ensure that its nutritional quality and taste are preserved throughout the product shelf life. After decades of Bisphenol A-based epoxy coatings use, the metal packaging industry moved to develop new non-BPA coating technologies and new methods to assess their safety beyond regulation requirements.

In absence of harmonized regulation for can coatings in Europe, other than the framework regulation 1935/2004 and GMP 2023/2006, industry has had to think out of the box and to find its way to generate the necessary data to conduct risk assessment and implement appropriate risk management, as well as submit dossiers to national authorities for approval.

This presentation will explore possible strategies for NIAS analysis and selection of appropriate testing conditions.

Page 9: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

Ewan Pickard Principal Scientist – Mass Spectrometry, Smithers Rapra, United Kingdom

Ewan is a Principal Scientist specialising in LC-MS. He studied Chemistry at the University of Nottingham and qualified in 2012 with MSci degree with the Master’s project focussing on the use of activated carbon as a hydrogen storage medium. He’s worked for Smithers Rapra since 2013 where he joined as an analyst. He’s worked primarily using LC-MS, but also has experience in GC-MS and sample preparation. Working at Smithers Rapra, Ewan has used LC-MS for food contact safety analysis, polymer failure diagnosis and reverse engineering of materials, but the majority of his experience has been analysing Extractables and Leachables samples.

A UNIFI workflow for Extractables studies using Ion Mobility-Mass Spectrometry.

The presentation describes the workflow for extractable analysis using Waters UNIFI software. The UNIFI software package is a powerful tool with a wide ranging functionality. The multitude of different options coupled with the large amount of data that can be produced by a Q-ToF instrument can mean that processing Extractables samples is a time consuming exercise.

This extractable workflow shows how the separate stages can be used to simplify the data processing procedure. This can cut down errors, reduce time spent data processing and allow for faster data checking. The workflow also includes use of custom fields to enhance the features of UNIFI. They are used to allow the combination of in-source fragments and re-arrangements of components as one component with a single response, as well as well incorporating library –matched internal standard response factor for use in semi-quantification.

Page 10: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

PARTICIPANTS LIST

FIRSTNAME/LASTNAME COMPANY COUNTRY SESSION

Cristina Acebo Gorostiza Ravago Group Spain Food Contact Materials

Ewelina Adamska GSK United Kingdom Extractables and Leachables

Rafael Amaral Hovione Farmaciencia SA Portugal Extractables and Leachables

Tim Averbeck Synlab Analytics & Services Germany Germany Extractables and Leachables

Joana Baptista Hovione FarmaCiencia SA Portugal Extractables and Leachables

Gitte Barknowitz Waters Corporation United Kingdom Food Contact Materials

Richard Bas Triskelion B.V. The Netherlands Food Contact Materials

László Bodai Gedeon Richter Plc Hungary Extractables and Leachables

Conny Bosmans ExxonMobil Belgium Food Contact Materials

Juana Bustos Centro Naciona Alimentacion-Aecosan Spain Food Contact Materials

Baiba Cabovska Waters Corporation USA Extractables and Leachables

Ana Causanilles Llanes Itene Spain Food Contact Materials

Sylvia Cunningham Merck KGaA Germany Extractables and Leachables

Michael Dermience ExxonMobil Belgium Extractables and Leachables

Nicola Dreolin Hall Analytical Laboratories L United Kingdom Food Contact Materials

Sarah Dubail Valspar France Food Contact Materials

Julien Echterbille Celabor Belgium Extractables and Leachables

Andrew Feilden Smithers Rapra United Kingdom Extractables and Leachables

Falk-Thilo Ferse Waters Corporation Germany Food Contact Materials

Katalin Ganzler Gedeon Richter PLC Hungary Extractables and Leachables

Maika Gomez Almenar Itene Spain Extractables and Leachables

Santiago Gomez Romero Argus Analysen Service GmbH Germany Food Contact Materials

Jeff Goshawk Waters Corporation United Kingdom Extractables and Leachables

Brunhilde Güssregen Merck Germany Extractables and Leachables

Stephanie Harden Waters Corporation Switzerland Extractables and Leachables

Elke Kassens Schuelke und Mayr GmbH Germany Extractables and Leachables

Michael Kaupp BYK-Chemie GmbH Germany Food Contact Materials

Roberto Menzel Sartorius Stedim Biotech Germany Extractables and Leachables

Bert Michiels Exxon Mobil Belgium Extractables and Leachables

Pauline Murat Pierre Fabre Dermo-Cosmétique France Extractables and Leachables

Cristina Nerín University of Zaragoza Spain Food Contact Materials

Andreas Nixdorf SGS Inst. Fresenius GmbH Germany Extractables and Leachables

Ioan Paraschiv knoell The Netherlands Food Contact Materials

Joel Pereira Biotechnology College Portugal Food Contact Materials

Diana Perrier Waters Corporation France

Ninon Piacere Celabor scrl Belgium Food Contact Materials

Ewan Pickard Smithers Rapra United Kingdom Extractables and Leachables

Fatima Poças Universidade Católica Portugue Portugal Food Contact Materials

Fanny Prevot Waters Corporation France

Rick Reiley GSK United Kingdom Extractables and Leachables

Heike Schmidt-Eisenlohr GBA Pharma GmbH Germany Extractables and Leachables

Jasmin Sefidroudi Synlab Analytics & Services Germany Germany Extractables and Leachables

Reinhard Stidl SHIRE Austria Extractables and Leachables

Christoph Thomas Waters Corporation Germany Food Contact Materials

Jacco van Dam Akzo Nobel The Netherlands Extractables and Leachables

Ganna Zinchenko Knoell NL B.V The Netherlands Food Contact Materials

Page 11: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European
Page 12: European Workshop on Extractables, Leachables and Food … · 2018. 5. 31. · MONDAY, JUNE 11 13:00 REGISTRATION AND LUNCH 14:00 Welcome and Introduction Dr. Falk-Thilo Ferse European

©2018 Waters Corporation.Waters, The Science of What’s Possible, Xevo, UNIFI and UPLC are trademarks of Waters

Corporation. All other trademarks are property of their respective owners.Printed in France, June 2018 – E&L/FCM2018 PAD•DPE