Cleanroom monitoring system aims to protect products and to maintain cGMP
A continuous record of data is always available with Veriteq's ViewLinc cleanroom monitoring system
The key objective of Veriteq’s ViewLinc cleanroom monitoring system is to protect products and to maintain cGMP (Current Good Manufacturing Practice) to meet FDA requirements. According to Ken Appel, marketing manager, regulated markets, for Veriteq, what sets the system apart from other cleanroom environmental monitoring equipment is that a continuous record of data is always available – even during network interruptions.
Many cleanroom facilities have traditionally used chart recorders to track conditions, but Appel says they are vulnerable to mechanical problems and other issues such as overwritten charts, dry pens, or failure during power outages, which results in data gaps. “Even more problematic is the fact that most chart recorders lack methods for remote alarming when conditions go out of tolerance,” adds Appel.
An increasing number of cleanrooms now use data loggers for monitoring critical environments, but Appel suggests that the accuracy of many devices is not sufficient for GxP environments.
By contrast, he says ViewLinc’s data loggers are the only monitoring devices to state measurement accuracy for one year post deployment, which gives users confidence in their data.
Another benefit of the ViewLinc solution is a significant saving in total cost of ownership because the system can be installed on any existing network via Ethernet, PoE (Power over Ethernet), WiFi or any combination. Other benefits include: secure, gap-free records for regulatory compliance; a 10-year battery and secure data backup on each logger; regulatory requirement assurance with secure audit trail for 21 CFR Part 11 and other international regulations; and one-year stable measurement accuracy to ±1%RH and ±0.10ºC and resolution of 0.05%RH and 0.02ºC (at 25ºC).