The Team

Michelle Scott, MS CCC SLP

Founded thriving Private Practice-20 years strong, Named Alabama Top 25 Women in Tech, AAMI committee for Industrial and General Sterilization, ACCA Biotech Task Force, Co-author for TIR 124:1 Guidelines for CD Sterilization, Kilmer Committees for CD and Materials, PDA and ASTM Sterilization Committees, ASN innovation Board, South Alabama Region Bio Ecosystem Strategic Planning Committee

Kevin Seiki, Engineering Advisor, Founder Operational Velocity, 28 years medical manufacturing and engineering including time at Edwards, Abbot and Covidien, NIH Subject Matter Expert

Aaron Black,Technical and Quality Advisor, Director of Operations and Engineering at Operational Velocity, 30 years in medical manufacturing, NIH SME, Operations Leader for startups in multiple national manufacturing sites.

Karen Simmons,Fractional CFO, serial founder, Instrumental in raising funds for over 50 successful ventures

Tara Waldron, Chemist, Certified Chemical Hygiene officer, Internal ISO auditor

Elizabeth Park, Board Certified Radiologist and Equipment Procurement for Radiology Department, USA Medical Center

The Gulf Sterilization Advantage

The Gulf Sterilization Advantage: True Turnkey Validation Unlike traditional contract sterilizers that require manufacturers to develop their own validation strategies, Gulf Sterilization provides a complete, pre-validated framework that dramatically reduces validation timelines and costs: Comprehensive Validation Documentation Suite: Pre- developed microbiological validation documents aligned with ISO 14937, ISO 11138, and ISO 11737 standards eliminate months of protocol development • Process Challenge Device (PCD) System: Scientifically designed PCDs specifically developed for chlorine dioxide sterilization streamline the establishment of worst-case challenge locations • Device Configuration-Based Challenge Mapping: Our structured approach systematically identifies and validates critical challenge locations based on your specific device geometry, materials, and packaging • Risk-Based Validation Framework: Quality planning guided by ISO 14971 and ISO 24971 ensures regulator

Comprehensive Validation Support Our structured validation approach covers all critical elements: • Cycle Development & Optimization: Product-specific cycle parameters established through systematic testing • Microbiological Process Qualification: Full or partial kill studies using model PCDs and product sterility resistance data • Residual Validation: Comprehensive residual testing per ISO 10993-7 and USP 300.10 at certified cGMP laboratories • Method Suitability Testing: Validated analytical methods ensuring reliable quality control

The Team

The Gulf Sterilization Advantage

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