Mark Dott, LLC

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Microbiology Validation

 

With an M.S. in Microbiology and experience in laboratory operations and USP / AAMI method validation, Mark Dott LLC offers consulting for the following items:

  • Biological indicator / BI testing
  • Sterility testing, including bacteriostasis/fungistasis (B/F)
  • Bioburden testing

Cleanroom consulting is also available, for medical device manufacture and packaging areas, sterility testing, and HCTP procurement & processing:

 
  • Cleaning validation for the qualification of cleaning / resterilization procedures for medical device instruments, procedural kits and instrument sets per AAMI TIR 12 and TIR 30
  • Disinfectant-cleaning validation to qualify cleaners-disinfectants to be used in cleanroom or processing areas
 

Thermal mapping services are also available for IQ/OQ of items such as freezers, refrigerators, incubators, ovens, sterilizers, stability storage chambers, etc., using calibrated wireless programmable temperature loggers.

 

 
Insuring compliance for your sterilization and microbiology processes

Medical Device Consulting - Sterilization and Microbiology