Speakers from the <660> Expert Panel at United States Pharmacopeia (USP)
Dr Bettine Boltres
WestPharma, Eschweiler, Germany
Member of the General Chapters-Packaging and Distribution Expert Committee at USP, Co-Chair <660> Expert Panel
Bettine Boltres is a frequent speaker at industry conferences and has chaired, moderated, organized and held numerous technical training events, conferences and workshops. A number of articles for several global magazines have also been penned by her, as well as the book “When Glass Meets Pharma”. She is actively working in the USP Expert Committee “Packaging and Distribution”. In Addition, she is a member of the EDQM Working Party Glass. With her former work as Product Manager for SCHOTT Pharmaceutical Tubing and her current position as Technical Account Manager at West Pharmaceutical Systems she covers the broad spectrum of both glass and elastomeric parts of primary packaging materials. By profession she is a chemist with a PhD in biochemistry.
Dr Michael Eakins
Co-Chair of Expert Panel and Member of USP General Chapters – Packaging and Distribution Expert Committee, New Jersey, USA
Michael was Senior Director of Product Internationalization for Bracco S.p.A. responsible for the strategic development of new packaging within R&D and then Senior Director of the International Packaging Center for Corporate Worldwide Sales and Marketing. He was Co-Chair of the Parenteral Drug Association’s (PDA) Glass Task Force on the Classification of Nonconformities in Molded and Tubular Glass Containers - published as PDA Technical Report 43 (2013). Michael has extensive experience in the packaging of drug products in glass vials and in glass and plastic pre-filled syringes, the development of extractable and leachable (E&L) protocols including compliance with European and US regulations and pharmacopeias. In addition, Michael provides assistance in the investigation of glass defects and glass delamination. He is currently a member of the USP Packaging and Distribution Expert Committee for the 2015-2020 cycle, having been Vice-Chair of the USP Packaging, Storage and Distribution Expert Committee for the 2005-2010 and 2010-2015 cycles.
Member of <660> Expert Panel at USP, SGD Pharma Packaging, Inc., New York, USA
Kevin is Quality & Technical Manager, Americas, at SGD Pharma Packaging, Inc., a manufacturer of molded and tubular glass primary packaging. His responsibilities involve all five of SGD´s plants located in France (2), Germany, China and India, and all of SGD´s clients in North, Central and South America. He is a member of SGD´s global Quality Management team and works in close support to the central office regulatory affairs department in France. Furthermore, Kevin is the primary FDA contact for SGD´s DMF’s. Kevin is a PDA member and was on the Task Force for Technical Report 43 (Glass Container Defects). Currently he is a member of the PDA Task Force on Visible Particles (Glass Containers Sub-Team). Other professional associations include the ISPE (International Society for Pharmaceutical Engineering), ASQ (American Society for Quality) and American Association of Pharmaceutical Scientists (AAPS).
Dr Holger Röhl
Roche, Basel, Switzerland
Member of <660> Expert Panel at USP
Holger Roehl, Ph.D. is Head of Primary Packaging Development at Roche. He holds a doctorate in Physical Chemistry, with a focus on surface analysis, from University of Siegen (Germany). He has worked at the Materials’ Laboratory of IBM in Mainz, where he focused on surface analysis of hard disks by Mass Spectrometry (MS) during his doctorate. After successful completion of his studies, he went on to work for the German biotech company QIAGEN, where he specialized in the field of protein / peptide analysis by MS. In 2007, Holger joined SCHOTT Pharma Services as a scientific advisor, where he was responsible for performing studies on delamination, surface contamination, Extractables & Leachables, glass breakage and drug container interaction. Since 2012, he works at Roche where he manages a team responsible for all aspects related to the parenteral primary packaging components including vials, cartridges, ampoules, stoppers, and caps.
Speakers from Industry
Roche, Basel, Switzerland
Frank is a Plastic Engineer by training and conducted his study at the University of Darmstadt in Germany. He holds a MBA in business sciences from the University Bern in Switzerland. Frank joined Roche in Oct 2011 and leads the Engineering Group Pre-Fillable Syringe. Prior to his time at Roche, Frank was 10 years with SCHOTT Switzerland as Head of Business Development and Customer Service Syringe.
NiproGlass, Münnerstadt, Germany
Alfred Breunig is the Director Technical Customer Support & Regulatory Affairs at Nipro Pharma Packaging Germany GmbH (NPG). NPG (former “MGlas AG”) is a manufacturer of primary packaging materials made of tubular glass for the pharmaceutical industry. After heading the chemical-physical and microbiological laboratories from 1982 to 1990, he became the Quality Director. In 2004, he took over the newly created position of the Director Technical Customer Support & Regulatory Affairs. He is Chairman of the Working Group “Quality Assurance for Primary Packaging Materials Made of Tubular Glass” in the BV Glas (association of the German glass industry). Furthermore, he is Chairman of the standardization committee NA 063-02-11 (“QM Systems for Primary Packaging Materials”) at the German Institute for Standardization (DIN, Berlin) and member/expert of the standardization committees (DIN) NA 063-02-01 ”Injection Systems“, NA 063-02-03 “Infusion and Injection Containers Made of Tubular Glass” and NA 063-01-11 “Small Bore Connectors”.
Dr Claudia Heinl
Schott, Mitterteich, Germany
Claudia Heinl, Product Manager Pharmaceutical Tubing, SCHOTT AG, is a chemist by training and has obtained her PhD in Inorganic/Organometallic Chemistry at the University of Regensburg, Germany. In December 2015, she joined the Scientific Services and Product Management team of SCHOTT AG Tubing for providing global scientific support about glass. This primarily includes glass trainings for converters and pharmaceutical companies, fault analyses of defect samples as well as advice on specific regulations.
HK Packaging Consulting, Uznach, Switzerland
Prior to becoming a consultant, Horst Koller worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focussing on Technical, Regulatory and QM Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences.
Dr Oliver K. Valet
rap.ID Particle Systems GmbH, Berlin, Germany
Oliver Valet is one of the co-founders and Managing Directors of rap.ID Particle Systems GmbH, which develops, manufactures and sells rapid particle identification systems. In Europe, rap.ID operates as contract testing laboratory for FPM ID in parenteral drug products. rap.ID Inc. based in New Jersey, USA, has years of invaluable experience and knowledge, in regards to customized application development and analysis services. rap. ID’s technology has combined particle isolation, imaging analysis and spectroscopic technologies, creating investigative tools for particle identification and characterization. Dr. Valet has extensive experience in foreign particulate matter testing and Root Cause investiga tion. He has also worked on the development of accurate and reproducible technologies for characterizing silicone oil layer thicknesses, and its distribution in parenteral packaging materials. He has published his work continuously and presented on various conferences all throughout Europe and the USA.
ICG, Nuova Ompi, Piombino Dese, Padova, Italy
Daniele Zuccato achieved his Master Degree in Industrial Chemistry at Venice Cà’ Foscari University in the framework of a collaboration project with the National Research Council Institute on the speciation of heavy metals in foodstuffs with HPLC-ICP-MS hyphenated techniques. In 2009, he joined the R&D Glass Division of the Stevanato Group as project leader of the investigation studies on the migration of trace elements from the glass surface, following and coordinating from the very beginning the startup of the SGlab and assuming the position of Core Team Leader, in charge of the physicochemical improvement of pharmaceutical glass primary packaging. Dr Zuccato is member of ISO TC76/WG2 and secretary/ member of TC 12 “Glasses for Pharma” of the International Commission on Glass (ICG).
Dr Jörg Zürcher
Bayer AG, Berlin, Germany
Chair of EDQM Working Party Glass
Dr Zürcher joined Schering (since 2007: Bayer AG) in 1990. Starting with systems for solid and semi-solid formulations his focus is now on the development of state-of-the-art container closure and application systems for liquid dosage forms, sterile products, inhalatives and ophthalmics.
Speakers from Authorities
Dr Katrin Buss
Regulatory Expert, Bonn, Germany
Katrin Buss is a pharmacist and received her Ph. D. in Pharmaceutical Biology in 2000. She worked as a Scientific Project Manager at Memorec/ Miltenyi Biotech from 2001- 2004. Since 2005 she is a Quality Assessor in the Biotech Unit at BfArM (Federal Institute for Drugs and Medical Devices, Germany).
Dr Ellen Pel
Ph. Eur., EDQM, Strasbourg, France
Ellen Pel is scientific officer to groups of experts in charge of the elaboration of European Pharmacopoeia texts related to containers for pharmaceutical use, antibiotics, radiopharmaceuticals, pesticides, medicinal gases and a number of general methods. Before joining the EDQM in 1996, she held an expert and a post-doctoral position at the Institute for Reference Materials and Measurements (IRMM), European Commission Joint Research Centre in Geel, Belgium. She obtained her degree in food chemistry from the Technical University of Karlsruhe, Germany and her PhD in the field of radiochemistry from the same university.
Dr Charudharshini Srinivasan
Food and Drug Administration (FDA), USA
Dr. Charudharshini Srinivasan is currently at the US-FDA, as a Research Scientist and a Reviewer in the Office of Testing and Research (OTR), Center for Drug Evaluation and Research (CDER). Her work focuses on regulatory research on parenteral formulations and packaging; use of PAT in lyophilization process understanding; evaluation of drug product quality and regulatory review. She currently serves as the government liaison to the USP Expert Committee -Glass Expert Panel. She is also the OTR representative for emerging technology program (ETT) at the agency for new packaging design for parenteral products.