Project Synopsis

Provide on-site process engineering support to a pharmaceutical plant’s Project Engineering group.

Project Summary


The client owns and operates a facility that manufactures Active Pharmaceutical Ingredients.  The facility adheres to FDA cGMP regulations and OSHA Process Safety Management (PSM) requirements.  Process Engineering Associates, LLC (PROCESS) was contracted to provide on-site technical support to assist Project Engineering with the execution of capital projects.

Specific project descriptions for which assistance was provided include the following:

  1. Installation of nitrogen feed system(s) for inerting several production scale reactors.
  2. Design and installation of small feed tank for a Pilot Plant spray dryer.
  3. Installation of a used jacketed reactor for production.
  4. Retrofit of critical chemical storage tanks with level sensors and safety interlocks (via Delta V DCS) to automated inlet valves to prevent tank overfilling.

Specific project tasks included:

  • Worked with Facility Production Management to define the scope of work for capital projects.
  • Generate Bid Specifications for mechanical/electrical contractors to solicit for project estimates.
  • Generate specifications for project-related equipment including:
    • Materials of construction for process piping for various corrosive chemicals
    • Automated valves
    • Level transmitters
    • Pressure transmitters
    • Pumps.
  • Generate cost estimates and schedules for capital projects.
  • Work with facility Safety, Health and Environmental (SHE) department to adhere to all applicable SHE and cGMP regulations during the completion of projects.
  • Generate Work Instructions for new processes.
  • Review and revise Functional Requirement Specifications (FRS) for programmable logic controllers (PLC) upgrades associated with new instrumentation installations.
  • Perform Pre-Startup Reviews (PSSRs) with production personnel including training on new equipment before the turnover of new systems.
  • Generate recommended spare part lists and recommended preventive maintenance frequency to facility Maintenance Department after installation of new system/equipment.

Industry Type

  • Pharmaceutical Manufacturing

Utilized Skills

  • On-site project engineering support

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