Fit Facility™ Program

Fit Facility

Fit Facility™

Biopharmaceutical facilities continually experience the combined challenges of efficient, uninterrupted production, while maintaining consistent regulatory compliance. Daily manufacturing demands can promote actions such as short-term patches on deficiencies, retention of inefficient processes and technologies, deviation from SOPs, rushed expansions and/or process modifications, and potential problems being ignored.

CRB’s Fit Facility™ Program provides a proactive and systematic health check of facilities. It is designed to reveal risks that contribute to failed batches, product/delivery shortages, product contamination, and ultimately regulatory violations. As a world leader in facility design, engineering and construction, CRB brings 30+ years of expertise in bioprocessing design, consulting, and driving the industry forward. In addition, CRB has co-authored many of the standards that serve as the basis of biopharmaceutical manufacturing. CRB’s Fit Facility™ team has provided fully integrated remediation and safeguard solutions with proven results that exceed industry benchmarks. We are experts at identifying deficiencies and potential risks in order to protect your business from costly failures - providing full service positioning for your success.

How Fit Facility™ Works

The Fit Facility™ program starts with assessments at periodic intervals to build systematic risk mitigation and peak performance into your culture. This program aligns with objectives to modernize a site, evaluate and optimize processes, rework equipment, and retrain personnel.

Assess

The Fit Facility™ program can be tailored to your unique circumstances. The preferred proactive assessment identifies discrepancies with industry best practices, deficiencies requiring action, reliability issues, and areas where problems may be imminent.

  • Equipment failures
  • Deviations and/or contaminations
  • Cleaning, sanitization and sterilization failures
  • EH&S procedures
  • Regulatory agency requirements
  • Appropriate process closure for environmental classifications

Report

Our Fit Facility™ assessment report includes corrective actions that will achieve compliance, mitigate failures and optimize productivity – all aligned with your business strategy and budget.

  • Identification and classifications of risks and hazards
  • Corrective measures to address items identified as high risk
  • Observations and preventative actions that should be addressed
  • Prioritization / schedule that aligns with your strategy and budget

Fix

Leveraging our industry-leading experience in facility design and construction, CRB can execute all phases of corrective and preventative remediation to realize your success.

  • Remediation of all problems on an agreed schedule
  • Mitigation of regulatory observations, failed batches and product shortages
  • Scheduling and cost planning aligned with your strategy & budget
  • Implementation of best practices and optimized SOPs
  • CRB Fit Facility™ dashboard enables streamlined project management

FIT

Your Fit Facility™ is fully prepared for regulatory audits and optimized to deliver a competitive advantage. Ongoing assessments make certain peak performance becomes part of your culture.

  • Provide the tools to improve regulatory compliance
  • Improve operational success, exceeding industry benchmarks
  • Improve public/regulatory relations
  • Implement today’s optimum technologies and best practices
  • Build a strong long-term foundation for your facility and business