This Cell Culture Media training will review the different performance parameters and describe challenge test results which have been found in a comparison study of multiple 0.1 micron rated filters.
Commonly 0.1 micron rated membrane filters are used to filter cell culture media. The importance of such filter systems increased due to recent increases in cell culture contaminations by Mycoplasma. Nevertheless, since there is no standard challenge test 0.1 micron rated filters are not comparable to each other and the performance of these filters vary greatly. Performance does not only mean unspecific adsorption and total throughput parameters but also retentively. The talk will review the different performance parameters and describe challenge test results which have been found in a comparison study of multiple 0.1 micron rated filters.
Areas Covered in the seminar:
- What performance variations in total throughput exist due to different media compositions.
- What process parameters or membrane structures influence retentivity of Mycoplasma.
- What new activities are established to tackle the contamination problem.
- What to validate or how does one get retention assurance.
- How to size a filter system.
- Will there be a standard challenge test for 0.1 micron rated filters.
- Facts & Figures on Mycoplasma contaminations.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their sterilizing grade liquid filters within the pharmaceutical and biotech processes. The employees who will benefit include:
- End-users of sterilizing grade filters
- Validation manager or specialists
- Regulatory manager or support
- Quality assurance manager
- Regulatory agency personnel
- Consultants
Instructor Profile:
Maik W. Jornitz, (Ph.D.) is Group Vice President Marketing at the Sartorius Stedim Biotech Inc. With over 20 years of experience, Mr. Jornitz supports the biopharmaceutical industry on a world-wide basis, in validation, integrity testing, membrane filtration of air and liquids. As Chair-Elect of PDA, Jornitz has been part of multiple PDA task forces, committee member and chair. He is also member of ISPE, DIA, ASTM and ALSAC. Jornitz is the author and co-author of close to 80 professional papers, 8 books and 6 book chapters. As faculty member of PDA TRI he trains industry members and regulators on a frequent basis. He holds several filter related patents and is the founder of Bioprocess Resources LLC.
Mr. Jornitz received his Diploma in Bioengineering at the College for Advanced Technology in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.
