Reducing Costs in Pharmaceutical Warehouse Validation: A Case Study

Reduce Warehouse Mapping Time, Cut Validation Costs by 60%

When choosing a system for thermal validation/mapping in pharmaceutical warehouses, the question of downtime is always a major concern.

With a thermistor-based validation solution, downtime can be reduced to almost nothing; in some cases, normal warehouse operations can continue during the study. Veriteq's warehouse mapping system is so quick and simple to install that operational interruptions are kept to an absolute minimum, even in high traffic warehouses.

Our thermistor-equipped data loggers provide stable accuracy in thermal validation from -86°C to 150°C (-123°F to 302°F). The sensors eliminate the many innate error sources of cumbersome thermocouple-based validation methods.

For pharmaceutical warehouse mapping, Veriteq's VL data loggers combined with vLog™ software, provide fast set-up and simplified warehouse validation study implementation. There are no thermocouples to place and safeguard for the length of the validation.

Our warehouse validation system has been put to the test by AMEC, an international project management and services company that employs over 44,000 people in more than 40 countries. The biopharmaceutical division provides design, construction, support and validation services to pharmaceutical companies worldwide. The following case study shows how one group within AMEC was able to reduce warehouse validation costs.

Challenge: FDA-Regulated Environment Mapping Needs

Within the pharmaceutical industry, mapping temperature and humidity in controlled environments is vital to the production of drugs and biotechnical products. In recent years the requirement for validation has extended to include storage facilities that comply with cGMPs. However, expanded validation requirements can mean increased costs for storage and processing for critical products.

“The FDA has clearly indicated that pharmaceutical companies are responsible for appropriate storage until drug products reach the final consumer,” says Ed Crowder of EC Squared Validation. In his work within AMEC’s Industrial and Infrastructure Division, Crowder oversaw environmental validation warehouses and storage facilities. By using Veriteq’s vLog™ validation system instead of a thermocouple-based system to validate temperature and humidity in pharmaceutical warehouses, AMEC offers significant savings to its clients.

The Trouble with Thermocouples

Although they are traditionally used to map warehouses that must comply with cGMP regulations and guidelines, thermocouples are difficult to use, especially over a large area. The wires must be placed throughout the warehouse using a process that is both time-consuming and disruptive.

Painstaking efforts — including pre- and post-calibration — are taken to ensure accuracy. However, these efforts are often wasted; thermocouples are fragile and easily damaged — even careful handling causes measurement errors and degrades accuracy with each validation study. The entire length of the thermocouple is a sensor, not simply the junction point. Each twist, pull and bend introduces error into the measurement.

To overcome many of the challenges presented by thermocouple systems, Ed Crowder used Veriteq’s validation system to map temperature and humidity in several AMEC pharmaceutical warehouses.

A Cost-Saving Solution for Pharmaceutical Warehouse Mapping

Crowder says, “We first began working with Veriteq's data loggers for validation about five years ago when one of our clients purchased a system. At first, we used them for mapping refrigerators and incubators. We soon saw how much time and money could be saved by mapping large warehouses with the Veriteq system.” He notes that while setting up a thermocouple system in a large GxP warehouse can take up to three weeks, installing a data logger based system to map a comparable space can be accomplished in only a few hours.

“Our customers save around 60% in costs — literally thousands of dollars — for thermal and humidity validation.” Crowder says that occasionally clients express reservations about switching from thermocouples to data loggers for mapping, “But when they learn that they won’t have to shut down their warehouses and see how much money they can save, they’re convinced. Once you use them, you wouldn’t think of using anything else. There’s just no comparison between data loggers and other systems.”

Today, AMEC uses Veriteq VL-series data loggers to map warehouses of 250,000 square feet or more. Veriteq’s VL loggers feature high-stability internal sensors that eliminate the need for time-consuming pre- and post-calibrations, a 10-year battery life and on-board memory to ensure reliable, non-stop recording, and all data files are encrypted for 21 CFR Part 11 compliant reporting.

To learn more about Veriteq's cost-saving solution for pharmaceutical warehouse validation and other thermal mapping applications, please call a Veriteq representative at (800) 683-8374, email veriteqsupport@vaisala.com or contact us online.