The Challenge

A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis.  The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area.  The project was part of a pilot project delivery method and involved adapting an industry standard warehouse HVAC design to meet the requirements for drug product storage.

The Solution

As one of many of Performance Validation’s pharma building commissioning projects, PV was able to leverage knowledge and experience from previous projects and work with the design-build contractors to deliver a complete commissioning solution for the facility.  Temperature mapping was implemented to analyze temperature distribution throughout product storage areas and identify areas for improvement prior to completion of construction.  On-site audit support was also provided during two mock audits to assess operational readiness prior to going live.

The Results

The end result was a facility that was verified and documented to be installed and function per design/construction specifications. The new distribution warehouse was able to efficiently meet the temperature requirements for drug product storage.  Temperature mapping data was used to design a redundant environmental monitoring system that was qualified for constant monitoring of critical temperatures.

The Benefits

The project accomplished the following for the distribution warehouse:

• Increased reliability, life expectancy, and operational efficiency while reducing operational costs of critical building systems including CRT storage HVAC, refrigerated storage HVAC, administrative area HVAC, freezer storage HVAC, hot/cold water, and back-up generator
• Commissioning temperature mapping data was used by engineering to determine permanent monitoring sensor locations
• Qualification temperature mapping data ensured temperature distribution met ISPE requirements for CRT, refrigerated and freezer areas for drug product storage.

For additional information, contact:

Brad Henry
Vice-President, Division Director, Indiana
Performance Validation, Inc.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana
(317) 248-8848
(317) 727-8495 Mobile