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Environmental Quality Corner with Ken Appel

FDA Compliance

The New Mind-Set of the Pharmaceutical Industry

Pharmaceutical and biotech industries prioritize reliability and environmentally-friendly solutions above purchase price.

Published: Tuesday, April 27, 2010 - 08:59

Having exhibited at INTERPHEX for many years, Veriteq, a provider of environmental monitoring and validation solutions, has made many connections with leading pharmaceutical and biotech companies. The Veriteq team attending INTERPHEX 2010, on April 20–22, was struck by two trends in the pharmaceutical industry that were especially apparent in this year’s show.

First and foremost, there’s good reason for optimism with capital equipment purchases, as they are a bellwether of the health of the pharmaceutical industry, specifically and to a certain extent, to the economy as a whole. While the number of attendees at the show continues to decline, who came to the show was notably different. Nearly all of my conversations at the event were with top-level managers who had authority and budgets to proceed with facility renovations. The near freeze on updating equipment to newer models—environmental monitoring instrumentation, refrigerator/freezers, chambers, incubators, etc.—throughout the industry in the past few years seems to be over.

Visitors to the Veriteq booth were, by and large, looking to spend money wisely, seeking to eliminate the problems they have been experiencing with the make-do equipment purchases they had made during recent lean years, when budgets were tight or sometimes nonexistent.

For example, a quality manager of a biologics manufacturer shared some experiences of the last few years of having to work with a low-cost, poorly engineered monitoring system his company had acquired because it was the only one within the company’s budget. This system, adapted for a project, gave the quality manager more than 500 false alarms during one weekend. Along with the management nightmare of handling the false alarms was the bigger worry of overlooking real alarms because their system had “cried wolf” so many times.

With money beginning to free up, this quality manager, like so many others, was now interested (and able) to learn about better, more accurate clean room monitoring instrumentation, such as that offered by Veriteq. Not long ago, that same conversation would likely have been more focused on purchase price and far less on performance comparisons. The mind-set throughout INTERPHEX had a lot less to do with up-front costs of instrumentation and everything to do with lifetime costs—even for those who had yet to experience losing valuable inventory or gaps in monitoring records, or who had not dealt with mechanical problems with chart recorders, loggers that were found to be out of spec when brought in for recalibrations, and so forth.  

The second trend of note is that the pharmaceutical industry seems to be looking for more “green” solutions. True, the last day of the INTERPHEX show coincided with Earth Day, but my hunch is that the bottom-line impact of energy-efficient technology is a bigger driver of this new market appetite. For example, it was apparent that more energy-efficient refrigerators and freezers were drawing great attention. 

The adage has always been that economic downturns force companies to work smarter. From my vantage point, and having been fired up by more detailed conversations about FDA compliance and product safeguard measures during the three days of the show, I may be seeing this predicted sea change coming to fruition. INTERPHEX 2010 tells me that we’ve all turned a corner.  



About The Author

Environmental Quality Corner with Ken Appel’s picture

Environmental Quality Corner with Ken Appel

Ken Appel, author of Quality Digest’s Environmental Quality Corner, is manager regulated markets for Veriteq, a Vaisala company. Veriteq provides environmental monitoring of temperature, humidity and other critical variables in controlled environments for regulated industries and other critical storage applications where product loss or audit failures are unacceptable.