The advanced course is a three day laboratory course of 30% lecture and 70% hands-on training. The coursework includes measurement of unspecific adsorption on different filter membrane polymers and the implication of such adsorption for any filtration process. Since filter sizing and optimal filter combination choice is essential for biopharmaceutical filtration processes, the course also includes filterability trials, sizing and scaling. Interactively, groupwork will include determining which filter combination is optimal for particular case studies detailed by the faculty. In addition, integrity tests for liquid and gas filters will be performed, including trouble shooting to determine reasons for integrity test failures and counter measurements. Product wet integrity test limits will be determined in another segment of the hands-on training to be able to establish the correlation between product and water wet integrity test limits. The combination of theoretical and practical work makes this course a highly valuable experience for end-users, trainers and regulators.

Upon completion of this course, participants will be able to:

• Apply knowledge of filter properties, including hydrophilic/hydrophobic, asymmetric/isomorphic and retention properties
• Perform key filtration operations
• Identify filterability and scalability requirements
• Utilize sound judgment for filter selection
• Describe validation and performance qualification
• Differentiate and optimize filter arrangements
• Design integrity tests and trouble shoot

Maik W. Jornitz, Vice President, Business Development, G-Con, LLC.
With close to 20 years of experience in separation technologies and regulations, Jornitz supports the biopharmaceutical industry on a worldwide basis. As a member of the PDA Board of Directors, Jornitz has been part of multiple PDA task forces, for example, the PDA Technical Report No. 26, No. 40 and No. 41 task force. He is also member of the ISPE, ASTM, DIA, ALSSA and editorial board member of five scientific publications. Jornitz frequently gives training within the industry and recently trained FDA reviewers on filter validation. He is the author and co-author of over 60 professional papers and three book chapters on membrane filtration, integrity testing, and validation studies. He is co-editor and -author of the books Filtration in the Biopharmaceutical Industry, Sterile Filtration - A Practical Approach, Filtration Handbook - Integrity Testing, Filtration Handbook - Liquids and Filtration Handbook - Air and Gas. He holds several patents related to biopharmaceutical process equipment. Jornitz received his Diploma in Process Engineering at the College for Advanced Technology in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

Wayne Garafola, Field Application Specialist Biotechnology Division, Sartorius Stedim Biotech
Mr. Garafola received special training and has worked in the areas of membrane filtration technologies, sterilizing and pre-filtration, TFF, membrane adsorber (chromatographic) separations, Utility IQ/OQ (air/gas/water/steam), and various filtration applications. He has over twenty four years experience in the pharmaceutical and life science industries, working in a variety of positions from QA, R&D, Validation Services, and Technical Services.

To receive a discount when registering for both courses, please complete the registration form and fax it to +1 (301) 986-1093. If you have any questions please contact Patresa Day at + 1 (301) 656-5900 ext. 115.

All rates in US dollars.

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #439| ACPE #0116-0000-11-439-L04-P | 1.8 CEUs
Type of Activity: Knowledge, Application