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)
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 formedical 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.