Consultant for Sterilization, Sterilizer Validation, and USP / AAMI Microbiology
Mark Dott LLC Consulting Services provides skilled consulting in the areas of sterilization, ISO sterilizer validation, and the validation of GMP microbiology test methods.This includes Ethylene Oxide / EO, Steam, Gamma, and Sterrad processes, and the validation of numerous USP / AAMI microbiology test methods.
Over twenty years experience includes medical device (also instruments, sets, and kits), surgical implant, surgical disposable, human tissue / HCTPs, biologicals, contract test laboratory, and pharmaceutical industries.
Experienced…professional…responsive…thorough.When compliance is your priority, call us.
Sterilizer validation of Ethylene Oxide / EtO, Steam (autoclave), Gamma, and Sterrad (hydrogen peroxide) processes per published ISO and AAMI standards.Mr. Dott has validated, supervised, and/or operated all these processes. Advice on sterilization processes. Prepare validation protocols, execute validation activities, solve problems, review results, prepare final reports, train employees. Preparation of SOPs, establish product families, new product introductions, etc.
Validation of microbiology laboratory operations and USP / AAMI microbiology test methods including BI testing, USP sterility, bioburden, steam re-sterilization validations, disinfectant - cleaning validation, cleanroom operations & aseptic techniques, environmental monitoring of manufacturing areas and cleanrooms, etc.
IQ/OQ temperature mapping of environmental monitoring storage chambers. Provides software for trending and analysis of environmental monitoring data; software for Laboratory Information Management Systems/LIMS. Sterilizer validation online or on-site training. Purchase of new or refurbished steam or EO sterilizers. Temperature monitoring devices. Employee training presentations.