Episode #4 Optimising Contained Sampling in Pharma’s Quest for Quality, with Jorge Esteban, FAMAT Sampling

We are delighted to welcome Matt Hofacre, Senior Director of Technical Services for the Equipment and Services group at STERIS, to the latest Pharma Tech Talks podcast episode.   Matt joins our host, Christian Dunne, for an insightful and in-depth conversation about the importance and benefits of bio-decontamination in the pharma and life sciences sectors.   The pair delve into key topics, including the challenges of implementing these critical systems, how the industry has significantly changed over recent years, future trends and emerging developments, and how Annex 1 has impacted bio-decontamination systems.   Matt manages an international team of experts in the sterilization, washing, and bio-decontamination industry.   Having worked at STERIS for 25 years, Matt specializes in multiple sterilization modalities, washing, high-purity water, pure steam, and VHP bio-decontamination equipment for the life science and medical device industries.   He is also a presenter and trainer at corporate, industry, and academic conferences in North America, Europe, and Asia including The Parental Drug Association (PDA), International Society of Pharmaceutical Engineers (ISPE), INTERPHEX, ACHEMA, and the University of Tennessee-Memphis Medical Center, amongst others.   Matt served as co-author for PDA Technical Report 48: Moist Heat Sterilization Systems and has contributed to numerous other articles on steam sterilization, vaporized hydrogen peroxide (VHP) bio-decontamination and sterilization, pharmaceutical washing, WFI water systems, and pharmaceutical equipment selection.   Matt has a B.Sc. in Chemical Engineering from the University of Cincinnati and an MBA from Cleveland State University.

Caroline Hand, Evonik  Episode 2 of Season 2 welcomes Caroline Hand, Production Manager at Evonik.  Caroline joins Pharma Tech Talk host Christian Dunne to discuss the challenges and successes she experienced when delivering a state-of-the-art high-containment and sterile fill/finish line at Evonik’s Alabama plant.  Caroline is currently the Production Manager for fill finish operations at Evonik Industries’ Birmingham, Alabama, site.   In this role, she supports all aspects of aseptic fill finish manufacturing at Evonik, including serving as a technical lead for commercial technical transfers, managing capital projects, and serving as area manager for fill finish and final inspection operations personnel.    While at Evonik, Caroline was integral to the initial start-up of the VarioSys® Fill Line at Evonik Birmingham and led multiple complex upgrades to diversify Evonik’s capabilities. 

Pharma Tech Talks is back with a brand-new season jam-packed with the latest news, emerging trends, and insights from the pharma tech and manufacturing sector brought to you by some incredible expert guests!  We are thrilled to welcome John Stevens from MilliporeSigma, who joins host Christian Dunne to kick off season two. The pair delves into the fascinating subject of complex and highly potent API manufacturing and the critical challenges that pharma manufacturers face.  John Stevens received his Master's degree from the University of Wisconsin in Chemistry. He joined the MilliporeSigma CDMO team in 2004, working in API Manufacturing and tech transfer of custom HPAPI projects.  He was involved in the scale-up and tech transfer of several GMP HPAPI and complex API programs to GMP production and through PPQ to commercialization. He was also involved in several facility expansion projects and was responsible for equipment selection and qualification.     John is currently a technology manager for the MilliporeSigma Life Science Services Commercial team, which supports small molecule and ADC modalities.   

Episode 8 of the Pharma Tech Talks podcast welcomes Francesco Nucci, Product Manager of Granulation Equipment and Handling Systems at IMA Active Division, in Italy. After his master’s degree at Pisa University, Francesco started his career as a Salesman at Romaco Zanchetta, where he specialised in producing granulation, handling, and washing equipment for solid dose processing in the pharmaceutical industry.   Following an acquisition by IMA, he became the Product Manager for granulation, handling and washing equipment at the IMA Active division in 2007.   Francesco joins host Christian Dunne to discuss the innovations and evolution constantly occurring within the manufacturing of oral solid doses. They also delve into how machinery and equipment are continually improving to keep the operator safe by looking into the possibilities of fully automated dosing and dispensing systems up to robotics.   IMA Active is leading in handling, granulation, tableting, capsule filling and banding, weight checking, coating, and washing. Their extensive portfolio for manufacturing oral solid doses, coupled with several inspiring innovations that have developed in key areas, is the backbone of their business.   Together with the consultancy they provide, cutting-edge technologies and services ranging from process engineering to technical assistance, IMA Active is well placed within the oral dosage manufacturing sector.

We are delighted to welcome Dr. Cordon Arpagaus to episode 7 of the Pharma Tech Talks podcast, who joins host Christian Dunne to discuss the topic of his recently published book, 'Spray Drying of Vaccines' in more detail.   This episode delves into the key motivating factors, advantages and challenges of spray-drying vaccines, how, where, and by what method vaccines are produced, and the key learnings Dr. Arpagaus personally took from the writing of the book.   Dr. Cordin Arpagaus is a process engineer with a master's degree from the Swiss Federal Institute of Technology Zurich (ETH Zurich). In 2005, he received his doctorate (Dr. sc. techn.) in plasma treatment of polymer powders from the Institute of Process Engineering at ETH Zurich. He also holds a master's degree in Business Administration from ETH Zurich.    Dr. Arpagaus then worked for several years in management positions at Swiss companies active in laboratory and process technology. Between 2006 and 2011, he was the Global Product Group Manager for laboratory Spray Dryers and Encapsulation Systems at BUCHI Labortechnik AG.    His focus was on developing new Nano Spray Drying Technologies and analysing current market trends in the pharmaceutical, materials and food industries. From 2011 to 2015, he was the team leader of technical support for sensors and laboratory products at Hamilton Bonaduz AG.   Since April 2015, he has worked as a Senior Research Engineer at the Institute for Energy Systems (IES) at the Eastern Switzerland University of Applied Sciences (OST). His research focuses on thermal energy systems and energy efficiency in industrial processes, particularly high-temperature heat pumps and heat pumps with turbo compressors.   So far, Dr. Arpagaus has published more than 50 research articles and review papers in international journals, including a book on high-temperature heat pumps and several book chapters on nano spray drying, and has given numerous presentations at international conferences.   As an active researcher in the International Drying Symposium (IDS) series, Dr. Arpagaus is also a member of the Swiss Society of Process and Chemical Engineers (SGVC), the International Institute of Refrigeration (IIR), and a reviewer for several international journals, including International Journal of Refrigeration (IJR), Applied Thermal Energy, Applied Energy, Renewable and Sustained Energy Reviews, and Energy.   Get your copy of Spray Drying of Vaccines, From Laboratory Research to Industrial Applications here.   Find out more about ChargePoint Technology here.

Episode 6 of the Pharma Tech Talks podcast welcomes Denise McIntosh & Scott Heffern from Custom Powder Systems in Springfield, Missouri. Since forming in 2005, the company has grown from 27 to 65 employees. The equipment designed and fabricated in Springfield, MO is operated in 19 countries around the world in the processing of pharmaceuticals, food and chemicals. Custom Powders provide a range of bespoke and standard solutions for dry materials, processing equipment, high containment and sterile processing sectors. They offer fully integrated turnkey solutions from front end design to validation and customer handover. Denise McIntosh is the CEO of Custom Powder Systems and Integrated Containment Systems, with her husband, Dale McIntosh, a veteran of the equipment industry. Denise earned a degree in Agricultural Economics from Oklahoma State University, and an MBA in Business Administration from the University of Nebraska at Omaha. She served as Board President and member of the Springfield Mid America Singers and is a former board member of the Missouri Association of Manufacturers. Scott Heffern is the Sr. VP of Products; Scott has a Bachelor of Science in Industrial Technology from the University of Wisconsin-Stout. He is a highly experienced engineer, specialising in all aspects of conceptual design, engineering and handover. In his spare time, Scott enjoys collecting and restoring vintage pinball machines, Soda machines and much more. Also designing innovative home improvements such as an attic elevator and a lawn irrigation system. Denise, Scott and Christian discuss the growing need for containment to improve manufacturing process efficiency and protect operators and products. Along with the industry trends in processing equipment, automation, and the rise of disposable single-use vs multi-use stainless steel technology. They also predict which trends will affect the pharma and biopharma industries in years to come.

Episode 5 of the Pharma Tech Talks podcast welcomes Claudio Fabiano from CSV Life Science Group in Italy. CSV serves its international customer base with Engineering and Validation Services, designing and supplying rigid and flexible isolators for containment and, more recently, skids for liquids preparation. Claudio started his journey in the pharmaceutical market by joining a company that provided Commissioning and Qualification services as a PM in international projects. After multiple years in the role, he took the chance to step into the sales department by entering the sales team of companies focused on equipment supply, mainly for primary packaging and cleaning in the pharma market. In 2020 Claudio returned to his origin by joining CSV Life Science Group as a Sales Manager, supporting the development of the  package of services and equipment provided by the group. Claudio joins host Christian Dunne to discuss how developing more complex formulations impacts equipment suppliers, how to improve containment strategy, continuous vs batch manufacturing, automation and how the growth of the CMO market is affecting process equipment.   Find out more about: CSV Life Science ChargePoint Technology

In our latest podcast episode, host Christian Dunne spoke to Jorge Esteban, CEO and Managing Director of FAMAT sampling, S.A, an engineering company designing and manufacturing sampling solutions for the Chemical, Pharmaceutical, Food and Bulk industries.  Jorge and Christian discuss the challenges facing companies looking to sample their potent compounds safely, efficiently and in compliance with regulations, along with our recent partnership to develop the ideal contained sampling solution.   Find out more about: FAMAT Sampling ChargePoint Technology

For episode #3 of the Pharma Tech Talks podcast, we welcome Head of Continuous Manufacturing at Gericke, Bernhard Meir. Bernhard joins host, Christian Dunne, to discuss why continuous manufacturing is becoming more popular in the pharmaceutical sector and what the main advantages of this technology are over the traditional batch process regarding containment. They also delve into a current hot topic in the pharma industry of process supervision, how this issue should be approached and what Berhanrd predicts for the future. As a research assistant and during his thesis at the Technical University of Munich, Bernhard Meir investigated the impact of parameters on feed rate fluctuations of a continuous blender. He joined Gericke as a project engineer, gaining extensive knowledge and experience in handling bulk solids. Today, he is the head of Gericke's department for continuous manufacturing.  With more than 125 years of experience in bulk materials handling, Gericke is the leading supplier of turnkey solutions for the continuous manufacturing of oral solid dosage forms. Find out more about: Gericke ChargePoint Technology

Vice President of Global Business Development at Freund-Vector, Jamie Frizzell, joins Pharma Tech Talks host Christian Dunne to discuss why sustainability, customisation, and automation are all key factors to remaining flexible in a continuously evolving pharma industry.  Jamie and Christian also delve into the current processing equipment trends, best practices, and what industry changes Jamie predicts for the future of processing equipment. Having spent nearly 29 years at a leading global manufacturer of pharmaceutical processing equipment for oral solid dosage manufacturing, Jamie has a vast range of knowledge and experience within the oral solid dosage realm, particularly in the containment of potent compounds, WIP/CIP systems, equipment and facility design and automated control systems.