SEP 02, 2015 1:30 PM PDT

Bioburden and Biofilm Control in the Pharmaceutical Industry

Presented at: Microbiology
Speaker
  • Manager, Sterility Assurance Research Center, Baxter Healthcare
    Biography
      Dr. Pasmore currently manages the Research Center in the Sterility Assurance department at Baxter Healthcare. His research includes biofilm analyses, rapid microbial methods, alternative sterilization techniques and new product development. He formerly has held the position of Assistant Research Professor at Montana State University, Department of Chemical Engineering. In his role at Montana State, he was the Medical Projects Supervisor at the Center for Biofilm Engineering where he studied biofilms in infection and medically systems, such as hemodialysis systems. Additionally, Dr. Pasmore worked as a Senior Engineer at STERIS Corporation where his research involved the evaluation and development of sterilization and decontamination technologies. He has multiple publications and presentations in the field of biofilm research and he is involved in several professional and standards organizations related to bacterial control and sterilization, including the PDA taskforce on BioburdenBiofilm Management.

    Abstract

    The Pharmaceutical Industry has a diverse set of products all with varying level of microbial risk to patients. On the low risk extreme there are topical pharmaceuticals on the other extreme are the injectable solutions. The higher the risk of patient infection the more controls must be put in place to control microorganism during the manufacturing processes. Pharmaceutical manufacturing companies producing sterile injectables must be ever diligent to control bioburden (microorganism present in their manufacturing operations). One of the most challenging aspects of that bioburden, and one of the least understood, is that of biofilms. Biofilms create challenges related to harborage, detection, and remediation of the bioburden present in manufacturing operations. This talk will discuss some of the challenges that biofilms create for pharmaceutical manufacturing, as well as some of the current practices to remediate these issues.


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