Fill Finish

WHEN THE STAKES ARE THIS HIGH, WHO DO YOU WANT BEHIND YOU?

With the level of complexity and risk inherent to aseptic processes, you need the assurance of a highly capable team of experts supporting you at the most critical stage of pharmaceutical development.

PASSIONATE, EXECUTION-FOCUSED EXPERTS.

CRB’s Catalysts for Success is a pioneering force of subject matter experts united in their commitment to delivering leading-edge aseptic and sterile fill finish operations. This cross-disciplinary group applies direct operational experience to meet the specific needs of your product—and your business.

For more than 25 years, our Catalysts have completed more than 220 filling line projects worth over $1 billion. This extensive track record, combined with in-depth knowledge of industry best practices and the global regulatory environment, enables them to implement the industry’s most advanced, comprehensive solutions to drive value across all key areas:

Production PlanningPRODUCTION PLANNING

  • Site selection, facility and master planning
  • Design risk assessment
  • Data-driven production capacity planning
  • Retrofitting to support future growth
  • Product forecasting and simulation

Operations & EquipmentOPERATIONS & EQUIPMENT

  • Long lead equipment planning
  • Experience-based knowledge of Critical Quality Attributes(CQAs) and Critical Process Parameters(CPPs)
  • Effective management of User Requirement Specifications (URS), bid packages and equipment

design iconDESIGN

  • Efficient equipment move-in and installation
  • Planning for site testing, commissioning, qualification, engineering, start-up and stability
  • Heavy industry engagement in aging equipment/facility retrofits and new equipment/ facility planning
  • Computational Fluid Dynamics (CFD) for air flow simulation
  • Product and critical utility sampling

ComplianceCOMPLIANCE

  • Intimate knowledge of the regulatory environment
  • Peer contributors to ISPE, FDA, MHRA and PIC/S regulatory documents
  • Experienced advisors on current best practices and industry trends

FacilityFACILITY

  • Equipment integration expertise
  • Facility maintenance support
  • Construction execution based on system turnover

Building= DELIVERY OF HIGH-PERFORMANCE BUILDING

EXPERIENCE A HIGHER STANDARD OF FACILITY DESIGN & EXECUTION

Catalysts for Success are respected experts in each discipline necessary to create safe, efficient and sustainable fill finish facilities. They are the ones you can trust to execute every step of the way — from early feasibility and design through construction, commissioning, qualification and into production. As experienced project managers, engineers and construction experts, CRB’s Catalysts apply their extensive knowledge and skills to deliver your world-class, production-ready facility on time and on budget.

Introduce Catalysts to your project today.

CRB’S CATALYSTS

Christa Myers – Sr. Specialist, Fill Finish
Lisa Dorn – Sr. Specialist, International Aseptic & Sterile Products
Melinda Smith – Sr. Specialist, Fill Finish
Mark von Stwolinski – VP, Facility Integration
Kevin Debbs – Specialist, Filling & Quality Documentation
Melissa Holshouser – Process & Facility Planner
Steve Wheat – Specialist, Regulatory
Jason Thomas – Project Manager, Filling Projects
Lindsey Stigers – Sr. Specialist, Facility Integration
Matt Hoover – Construction Operations Manager
Brian Kirk – Construction Project Director
Todd Vaughn – Sr. Specialist, Fill Finish