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SERVICES

Pharmaceuticals and Life Science

SPEC’s pharmaceuticals and life science services cater to the unique requirements, processes, and procedures needed for this field. Our experience in chemical and petroleum process design lead to a natural extension to the pharmaceutical industry. In addition to our process expertise, our staff is knowledgeable with the USFDA requirements unique to our pharmaceutical clients. SPEC has also earned a reputation as specialists in the implementation of mechanical integrity programs for pharmaceutical companies. Our staff routinely assists our pharmaceutical clients with the development, implementation, and evaluation of facility or of company-wide process mechanical equipment integrity programs. We have performed equipment inspections, inspection oversight, inspection report evaluations, suitability for service determinations, evaluation of time to failure, and development of return to service repairs of critical pharmaceutical process equipment. This service has assisted our clients in improving process equipment reliability and extended the equipment operating service life.

MARKET AREAS

  • Pharmaceutical Process
  • Equipment Mechanical Integrity
  • Biological & Life Science Process
  • FDA Regulatory Compliance Assistance

SERVICES

  • Mechanical Integrity Program Development & Implementation
  • FEED – All Disciplines
  • Code Evaluations (ASME, API, NFPA)
  • Utility System Evaluation & Planning
  • Pipe Stress Analysis
  • HAZOP Analysis / Risk Assessment
  • Plant Turnaround and Shutdown Support
  • Project Construction Cost Estimation
  • Local and Environmental Permitting
  • FDA Regulatory Compliance
  • Procurement Support
  • Construction Management
  • EPC
  • Commissioning / Startup Assistance
  • Automation System Programming & Integration
  • Fire Protection System Evaluation