Fundamentals of Aseptic Processing

Ms. Carver is a Senior Consultant and founder of Pharma Microbiology Consulting, LLC, where she specializes in pharmaceutical microbiology and aseptic processing. She has over 26 years of experience in the pharmaceutical/medical device industries. Work experience includes microbiology, aseptic processing, quality assurance/quality control, environmental monitoring, validation, sterilization, microscopy, and clinical product development/manufacturing support. She has managed microbiology laboratories for various well known organizations. In her last industry position, she was Associate Director Microbiology for Eisai Inc. in Research Triangle Park, NC, where she was responsible for supporting aseptic manufacturing lines and oral solid dose manufacturing as well as development of clinical drug products. She has started-up of two Microbiology Laboratories, supported validation of two newly constructed isolator lines, and designed and implemented environmental monitoring programs intended to satisfy worldwide regulatory requirements. Over the past five years as a consultant, Ms. Carver has provided training in microbiology and aseptic processing, performed GMP audits, and consulted on sterilization and microbial testing issues. She holds a B.A. in Bacteriology from DePauw University in Greencastle, Indiana. Ms. Carver has been a member of PDA since 1991 and is a former president of the PDA Southeast Chapter.

Mr. Garafola received special training and work experience in membrane filtration technologies, integrity testing, pre-filtration and sterilizing filters, cross flow separations, membrane adsorber (chromatographic) separations, Utility IQ/OQ (air/gas/water/steam), and various filtration applications. He completed a Bachelor of Science degree in Microbiology at Pennsylvania State University. He has over 27 years of experience in the pharmaceutical and life science industries, working in a variety of positions from QA, R&D, Validation Services, and Technical Services.

He shared the 2016 James P. Agalloco Award, for PDA TRI faculty member who exemplify outstanding performance in education, with co-trainer, Maik W. Jornitz. He has been a member of PDA for 25 years and teaching at PDA TRI since 2006.

Sean is a Sr. cGMP Consultant for STERIS, a U.S. based manufacturer of sterilization wrapping solutions and pre-sterilized cleanroom materials. Working within the Barrier Products Solutions group at STERIS, he has over 15 years’ experience in the industry, identifying and providing solutions for pharmaceutical and biotechnology clients around the globe with needs related to process improvements in component preparation, maintaining sterility, particulate reduction and aseptic technique.

As a subject matter expert on Good Manufacturing Practices for component preparation, maintaining sterility from the autoclave to the production area, and facilitating aseptic technique, he has been an instructor with the Aseptic Training Institute (ATI) since 2008, conducting trainings at their Clayton, NC and University of Cardiff, Wales facilities. Sean joined the PDA faculty in 2013. He holds a Bachelor’s degree in General Sciences, with a focus in Biology, from Rutgers University.

John Lyons is a pharmaceutical manufacturing professional specializing in aseptic processing. He is currently a Sr. Process Engineer at IPS (Integrated Project Services) and previous positions include Senior Engineer and Partner at Sterile Technology as well as Deputy Director of Operations for OncoGenerix's parenteral manufacturing facility in Mudanjiang China. At OncoGenerix, his responsibilities included coordination and oversight of manufacturing, engineering and administration departments to facilitate operational objectives; as well as interfacing with Quality Operations to ensure compliance with internal QMS and global regulatory requirements.

As a senior engineer, John's project experience includes the complete lifecycle approach from project conceptualization, design, construction, start-up and qualification through into operation. His specialist areas include barrier isolator systems, sterilization (H2O2, steam & dry heat), sterile component handling, sterile filling of vials & syringes, lyophilization & loading systems, commissioning and qualification, and the containment of APIs and potent compounds. He holds a B.S. in Computer Engineering from the University of Scranton.

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for over twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, the Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms, and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force. He was a co-author on PDA’s Technical Report #70 on cleaning and disinfection and Technical Report 88. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. His main hobby is tornado chasing and severe weather safety.