Case Studies and Reports

This session will provide the opportunity to hear “both sides of the story” from a non-sterile aqueous product contamination case. Speakers will present both industry and FDA perspectives from an actual product contamination event, and the path taken to resolve the problem. Attendees will discover how FDA and industry worked together to solve a microbial product issue, and the lessons learned from the case.

  • Factors affecting choice of antimicrobial agent
  • Properties of the chemical agent
  • Mycobacterium tuberculosis
  • Esters of p-hydroxybenzoic acid (parabens)
  • Toxicity of the agent
  • Bacterial spores
  • Vegetative bacteria
  • Acids and esters
  • Benzoic acid
  • Sorbic acid
  • Sulphur dioxide, sulphites and metabisulphites
  • Alcohols used for disinfection and antisepsis
  • Alcohols as preservatives
  • Aldehydes
  • Glutaraldehyde
  • Ortho-phthalaldehyde
  • Formaldehyde
  • Formaldehyde-releasing agents
  • Chlorhexidine and alexidine
  • Polyhexamethylene biguanides
  • Halogens
  • Hypochlorites
  • Organic chlorine compounds
  • Chloroform
  • Iodine
  • Iodophors
  • Heavy metals
  • Mercurials
  • Hydrogen peroxide and peroxygen compounds
  • Phenols
  • Phenol (carbolic acid)
  • Clear soluble fluids, black fluids and white fluids
  • Synthetic phenols
  • Bisphenols
  • Surface-active agents
  • Cationic surface-active agents
  • Diamidines
  • Dyes
  • Quinoline derivatives
  • Antimicrobial combinations and systems
  • Disinfection policies

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