Sterility testing - overcoming difficult products

Sterility test method validations can be as difficult as they are important, so understanding practical approaches, especially for products where pharmacopoeial methods cannot be readily applied, can be extremely beneficial.

Topic areas we cover include:

• The difficulties associated with sterility test method validation in general
• Practical approaches for products where pharmacopoeial methods cannot be readily applied
  • Examples: Mercurial compounds, antibiotics, turbid samples, medical devices, oily samples
• Some supporting aspects for sterility test method validation
• Essential validation documentation
• Guidance on training requirements

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorial boards and he has written over six hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.