Speaker Profile

Maik Jornitz

Chief Operating Officer, G-CON Manufacturing LLC

Maik Jornitz is Chief Operating Officer at G-CON Manufacturing LLC, College Station, TX. ?With over 25 years of experience in separation and single-use technologies, the related regulations and validation requirements, Jornitz supports the biopharmaceutical industry on a world-wide basis. As a former member of the PDA Board of Directors and Science Advisory Board (SAB), Jornitz has been part of multiple PDA task forces, for example the Technical Report # 26, #40, #41, #45, mycoplasma task forces, and program co-chair for the 2008 and 2013 Annual Meeting. He is also member of the ISPE, ASTM, DIA and is faculty member of PDA TRI. Jornitz authored and co-authored over 100 scientific papers. He is co-editor and -author of 9 books for example Filtration and Purification in the Biopharmaceutical Industry, Sterile Filtration – A Practical Approach, Pharmaceutical Filtration and received 5 distinguished author awards, a PDA special service and Michael S. Korczynski award. He has contributed in total 14 chapters to various technical books, including the Encyclopedia of Pharmaceutical Technology. He holds over 30 patents related to biopharmaceutical process equipment (single-use technology) and integrity testing. ?He formerly worked for Sartorius Stedim in various positions for over 25 years. In addition, he is the founder of BioProcess Resources LLC, a consulting group specialized in sterilizing filtration, integrity testing and single-use technology and Science Advisory Board member of Artemes Technologies. ?Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.?

Specialties: Technical expert in sterilizing grade filtration and single-use technologies within the biopharmaceutical industry, including regulatory requirements, validation, integrity testing, trouble shooting, systems design and optimization. Commonly advises, consults, trains, audits end-users and regulators. Specialty, optimizing processes by analyzing process steps technically and economically, which resulted to either cost savings or additional revenue potentials.

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Sterilizing Filter Process Validation - Essential Requirements

Sterilizing filtration, utilizing membrane filter often of 0.2 micron rating, are critical in aseptic processing. As soon as heat sterilization cannot be used or bioburden requires to be reduced before heat sterilization, sterilizing grade filters are installed to remove the microbial burden.

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