New Cleanroom Monitoring Solution

Pharmaceutical, biotechnical and critical environment quality managers who maintain absolute cleanroom conditions can now ensure gap-free records for temperature, relative humidity and differential pressure with the viewLinc™ 3-in-1 monitoring solution. Ken Appel, Marketing Manager, Regulated Markets for Veriteq notes the key objective of the viewLinc™ cleanroom monitoring system is to protect products and to maintain cGMP (Current Good Manufacturing Practice) to meet FDA requirements. Appel explained what sets the system apart from other cleanroom environmental monitoring equipment: “With viewLinc, a continuous record of data is always available - even during network interruptions.”

Many cleanroom facilities have traditionally used chart recorders to track conditions. “Unfortunately, chart recorders are vulnerable to mechanical problems and other issues like overwritten charts, dry pens, or failure during power outages, which results in data gaps,” said Appel. “Even more problematic is the fact that most chart recorders lack methods for remote alarming when conditions go out of tolerance.” Over the last few years an increasing number of cleanrooms have begun to use data loggers for monitoring critical environments. However, Appel says that the accuracy of many devices is not sufficient for GxP environments.

“The problems start when the loggers are recalibrated and it’s discovered that a sensor drifted out of spec. But the question is: how long has the sensor been out? And what products or processes were affected in the interim? These are hard questions no quality or regulatory professional wants to have to answer.” By contrast, viewLinc’s data loggers are the only monitoring devices to state measurement accuracy for one-year post deployment. “This allows you to feel confident in the integrity of your data,” stated Appel.