Hygienic. Processing. Solutions.
LotterBhanson, LLC provides specialized technical engineering, project management, and operational consulting for hygienic processing industries. Founded in 2019 by Clark K. Patterson, a licensed Professional Engineer and West Point graduate, the practice delivers expert support in facility design, construction, qualification, and maintenance for pharmaceutical and biotechnology operations. It actively participates in key industry bodies such as the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment Code Committee and Process Industry Practices (PIP) to apply up-to-date standards and cost-effective regulatory compliance strategies.
Licensed Professional Engineer
Clark K. PattersonPresident and CEO
Developing piping specifications, equipment datasheets, and cleanroom design layouts tailored for hygienic processes.
Creating material specifications for hygienic process tubing, high alloys, PVDF, and medical gas piping systems.
Drafting technical procurement sheets for rotating, packaged, and static equipment including CIP skids and pressure vessels.
Designing personnel, material, and waste flows alongside airlock pressure cascades to maintain ISO classifications.
Managing bio-pharmaceutical engineering projects from initial scope definition and budgeting to front-end execution planning.
Defining project scope, team coordination plans, construction bid packages, and process flow diagrams.
Facilitating Process Risk Assessments (FMEA) and direct-impact versus non-direct-impact system suitability evaluations.
Developing commissioning and validation frameworks compliant with current FDA guidance and ISO 13485 standards.
Evaluating utility performance, equipment suitability, QMS compliance, and maintenance program reliability.
Analyzing water, steam, and electricity usage against historical baselines and operational requirements.
Reviewing predictive maintenance schedules and critical utilities to optimize system reliability and safety.
Assessing existing quality management structures for manufacturing compliance and regulatory alignment.
Pharmaceutical · Life Sciences · Medical Devices · Food & Beverage · Consumer Products
Maryland Heights, MO · Life Sciences · 2020 · Client: Geneoscopy, Inc.
Supported the transition of a diagnostic biotechnology startup into a clinical diagnosis enterprise specializing in colorectal cancer detection. The project involved design and construction management for administrative and specialized laboratory facilities, integrating backup-powered freezer infrastructure, light-controlled clinical spaces, and pressure-balanced pass-throughs.