Project Synopsis

Provide process engineering assistance for various utilities and control systems as part of a health products plant restart project.

Project Summary


The client, a world-wide leading supplier of consumer health products, was in the process of re-starting an existing facility in the Northeastern U.S. that is FDA-regulated after a complete revamp and contracted with Process Engineering Associates, LLC (PROCESS) to provide on-site technical support to assist the maintenance department in completing a number of activities, including:

  • Provided an on site review of the newly installed U.S. Pharmacopeia (USP) water delivery system.
  • Developed and completed a testing protocol for the existing plant Process Soft Water system including identifying sampling points and working with the laboratory to establish test methods.  Worked with laboratory technicians and facility operators to obtain the samples.  The task included writing a final report summarizing results, documenting any deviations, and developing an additional sampling plan for more specific testing.
  • Developed the framework for a site wide Filter Integrity Testing program including identifying all filters in the facility that are in contact with finished products.  Determined which filters could be tested in place and developed requirements for those that would need modifications to test in place.  Supervised testing by the filter manufacturer for the integrity testing of four (4) existing filters to meet preventative maintenance requirements.
  • Worked with the client Facility Manager and client Validation Manager to close out the Commissioning Test Protocol (CTP) for the facility’s Clean Compressed Air (CCA) system.  This consisted of doing field verifications and working with the valve manufacturer to obtain certifications that valves were cleaned for oxygen service and updating turnover documentation to reflect this.
  • Worked with the instrument vendor and client automation engineers to set up five existing TOC analyzers to transmit alarm and error signals to the existing plant PLC.  This would allow plant personnel to be notified on off-shifts when the USP Water System was experiencing problems long before product quality was compromised.
  • Assisted the client Metrology Engineer in developing a security lock out program for all plant instruments.  This would prevent unauthorized modifications to instrumentation tuning and control parameters, hence helping ensure consistent product quality from batch to batch.
  • Assisted the client Metrology Engineer in clarifying calibration requirements for several critical plant instruments and helping ensure that all instruments were properly identified in the field.  An official documented calibration program is an FDA requirement for a facility that produces consumer products.
  • Designed and specified instrumentation to measure four vent temperatures in the existing USP water storage tanks and be able to monitor temperatures via existing facility PLC.
  • Developed the design and installation requirements and provided an estimate for the installation of a local ozone monitoring system in a remote area of the utilities room.  This will improve the safety of the facility for the utility operators.

The on-site assignment was successfully completed, and the client continues its project to start up its revamped world class facility.

Industry Type

  • Healthcare Products Manufacturing

Utilized Skills

  • Commissioning support
  • Startup support
  • Instrumentation systems support

Contact Us