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ABSTRACT:

The Importance of Manufacturing Support Programs for Ensuring Product Integrity

Recent shifts in local and international regulations governing biocides have impacted a diverse range of industries as they seek to meet regulatory and labelling compliance. Focus on biocide replacement strategies with potentially weaker options has placed greater emphasis on holistic approaches to ensuring product integrity.

This paper discusses a broad approach to achieving formulation and process control with consideration given to hurdle technology, good manufacturing practice principles and other key support programs including environmental monitoring as a predictive tool, and the use of endemic environmental and product isolates in the validation of new or modified biocide systems.

BIOGRAPHY:

Dr Tass Karalis is a Microbiologist with interests and experience in food, environmental, cosmetics, pharmaceutical and medical device sectors.  He holds both a BSc in Science and Mathematics at UNSW majoring in Microbiology and Biotechnology, as well as a PhD in Applied Bioscience at UNSW (Microbiology).

Experience has included;

• • Microbiology Research Consultant with the Food Industry Development Centre at the UNSW
  • Disease Surveillance with NSW Health
  • Laboratory Director with a number of commercial consulting laboratories including the Merieux Group and Bureau Veritas
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• Dr Karalis has  sat on various committees including the NSW Health Listeria committee, AQIS/Department of Agriculture Laboratory working group and the Microbiology committee of the Australian Institute of Food Science and Technology, had expertise in sterilization validation processes including Gamma irradiation, Ethylene Oxide and Heat Sterilization and is currently the Technical Manager at Thor Specialties