PDA 800.2 Fundamentals of Aseptic Processing

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 involves storm chasing, tornado research, and tornado safety.

With over 15 years in the pharmaceutical, biopharmaceutical and consumer industries, David has expertise in the quality systems leading to extensive experience in all aspects of manufacturing, validation, and inspection readiness, with a focus on process optimization and efficiency in resource utilization. His proficiencies include consent decree remediation efforts and management of quality systems, product tech transfer and rapid site growth training, pre-approval inspection readiness, commissioning and validation, and facility start-up.

David’s specializations include quality systems, sterile manufacturing, and technical training. He currently serves as the Vice President of Education for the Parenteral Drug Association (PDA) where he is responsible for the development and delivery of PDA’s training courses and the operation of the Training and Research Institute’s cleanroom and laboratories.

He has worked at Johnson & Johnson, MedImmune/AstraZeneca, Genzyme, Dendreon, and Bayer HealthCare. David holds an MBA with a concentration on operations management and a BS in chemistry from Washington State University.

Brent Watkins is currently the South East Technical Manager for Veltek Associates, Inc., providing contamination control products and services to the pharmaceutical and biotech industries. Prior to Veltek, Brent worked for Abbott Laboratories in small volume injectable operations in a variety of supervisory roles. In addition to his responsibilities at Veltek, he is a course instructor for aseptic processing related topics at the Parenteral Drug Association, was a member of the PDA task force for Technical Report 70 (Fundamentals of Cleaning and Disinfection), and currently serves as the Vice Chair of the Education Advisory Board. Brent graduated from Wake Forest University in 1995 with a Bachelor’s degree in Chemistry and lives near Rocky Mount, NC with his wife, Rebecca, and son, Jacob.