Filtration is used to separate unwanted contaminants, both viable and non-viable, from drug preparations. This highly interactive training course is intended to provide a fundamental understanding of biopharmaceutical filtrations and filters that will enable the participants to concentrate on the use of filters for the most demanding and critical operations for the manufacture of aseptic products.  This course will focus on:

• Practical applications and experiences of filter usage
• Economics and performance of systems designs
• Definition of filter suitability in terms of structure and property relationships
• Integrity test methods and importance
• Process validation of filter devices

Topics to be addressed include:

• Filter manufacturing and construction of membrane and depth filters
• Structural and design features of filters
• Contaminant retention including mechanisms for liquid and gas filtrations; e.g., sieve retentions, adsorptive sequestration, electric double layer effect
• Integrity testing including diffusional airflow, Bubble Point, pressure-hold and WIT
• Validation requirements; e.g., bacterial challenges and viability, extractable testing
• Troubleshooting

The course format will be lecture with interactive question and answer sessions. Both during the presentations and following presentations, time will be allotted for participants' questions.  Discussion is encouraged during course sessions.  Instructors will be available to respond to participant issues during and after the formal training sessions.

Upon completion of this course, you 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 #438 | ACPE #0116-0000-11-438-L04-P | 1.2 CEUs
Type of Activity: Knowledge, Application