Minus 6 Sterilization Consulting, LLC

We provide expert sterilization, microbiology, and quality system consulting services for the Medical Device industry. 20+ years combined experience in Sterility Assurance (EO & Radiation), QA Microbiology labs/Cleanrooms (pharmaceutical/medical device), and Aseptic Processing. Including: ISO 13485 auditing; Assessment of Product Design/Changes for adoption into EO sterilization cycles; EO sterilization cycle development, validation & requalification; Sterilization & microbiology supplier audits; Bioburden method validation; Cleanroom qualification (IQ/OQ/PQ), Well versed in: Bacterial Endotoxin Testing requirements and methods; EO Residual testing requirements and method

• Employees 1
• Founded 2022