Pharmaceutical Warehouse Validation: Case Study

Pharmaplan ValiCor is a leading provider of pharmaceutical consulting services, including temperature validation. Recently, Stephanie Cowan of Pharmaplan ValiCor told us how much setup time and preparation the Veriteq system saved them on a recent warehouse temperature study - 80% - compared to their traditional thermocouple-based system.

Many of the Veriteq advantages arise from the fact that Veriteq data loggers do not rely on thermocouples.

The Challenge

Validating the temperature distribution in a large pharmaceutical warehouse poses several challenges when using a thermocouple-based system:

• Disruption of the working environment
  Warehouses are active places, with forklifts and constant motion - its not hard to imagine the disruption caused by stringing thermocouple wiring throughout.
  
• Limited radius from the central unit
  With a multi-channel thermocouple system, all wires have to go back to a central unit, meaning that the radius of reachable points is limited by the length of thermocouple wires. For a 350,000 square foot warehouse the choice comes down to moving the central unit multiple times (each time setting up, calibrating, and taking measurements) or purchasing more central units, which can be expensive. In either case, the stringing of thermocouple wires makes it a very time consuming process.
• Finicky pre-cal and post-cal
  Thermocouple systems must be calibrated prior to, and after, every use, a requirement that is even more critical when using long cable lengths. This is a time consuming process that can be quite frustrating, especially if post-cal results are not satisfactory.
• Wiring can be very expensive
  For a large warehouse, long thermocouple probes can be costly and difficult to procure, especially since each probe has to be in one continuous length. Cowan estimates the Veriteq system saves them thousands of dollars on probe costs for each warehouse validation they perform.

The Veriteq Solution

Veriteq data loggers do not rely on thermocouples, but instead use high-stability on-board thermistors. Because of this, pre-cal and post-cal steps are not necessary. In addition, 10-year internal batteries allow Veriteq data loggers to operate independently of each another, in a modular fashion, without any wires - or wiring errors.

Another plus is the ability to record relative humidity. Although not required for all customers, Cowan says the Veriteq data loggers' ability to collect both temperature and humidity readings provides a more complete picture of the warehouse environment.

For Pharmaplan ValiCor, these advantages translate into time-savings and a competitive edge. The company was able to qualify the 350,000 square foot warehouse in "one-shot", using multiple Veriteq data loggers placed evenly throughout the warehouse - all while normal warehouse activities continued uninterrupted.

The ability to perform temperature testing without interrupting operations has allowed Pharmaplan ValiCor to enhance their other validation services as well. For instance, the company provides testing of all sorts of temperature-controlled facilities, including full production areas in active operation. "We can do the testing without causing the customer any downtime", says Cowan. "Using the Veriteq loggers and avoiding wires has been a tremendous help."

When asked again about the alternative thermocouple-based system, Cowan replied, "Its hard to even compare these two systems because we are talking about one tool that is right for the job, and one that is not. At this point I won't use anything other than Veriteq."

Note

Although Veriteq data loggers are completely self-contained and operate independently of each other, the data from each logger can be easily consolidated into one on-screen display or graph report - just as in a multi-channel system.

For more information on our solutions for pharmaceutical warehouse validation, please contact us.