viewLinc™ for Stability Chamber Applications - Temperature/RH Monitoring

Veriteq's stability chamber monitoring and validation tools are easy to use, reliable, and cost-effective. Simplify your compliance and stay audit ready with temperature and humidity data loggers that are designed for ICH stability applications and FDA-regulated environments.

For use in both mapping and monitoring applications, Veriteq's calibrated, NIST-traceable data loggers are the only devices to state Temp/RH accuracy 1 year after typical field use.

The Challenge: Stability Chamber Monitoring with CRs

Stability applications that rely on chart recorders for chamber monitoring can be time-consuming and inaccurate. Most regulated environments require a more robust and cost-effective method of monitoring stability chambers.

One of our pharmaceutical manufacturing clients had the following scenario after a 3rd-party audit revealed the their stability monitoring system's weaknesses:

• The chart recorders offered no protection during a power outage. At the most critical time of monitoring environmental changes, the chart recorder stopped working.


• Dubious accuracy of the records due to the mechanical nature of the CR system, changes in paper thickness and reliance on personnel.


• Poor record keeping. The space required to store charts was limited. There were also issues of paper running out or ink going dry. Vital data was easily lost, overwritten or misfiled.


• Control and monitoring of the chamber was performed by the same sensor, so problems with a sensor were invisible because conditions appeared to be normal.


• No reliable 24/7 alarm notification system.

This customer needed a better solution and initially considered hard-wired lab monitoring systems. At that point, two major concerns emerged:

• Hard-wired systems are expensive and demand annual maintenance contracts.
  
  
• A hard-wired system must be installed in its entirety, which means significant downtime. (All stability chambers must be empty and inactive simultaneously.)

The Solution: viewLinc™ for Stability Applications

After hearing about Veriteq's viewLinc for Chamber Monitoring, the stability manager decided to install this reliable and accurate monitoring system with minimal hassle and at reasonable cost.

• 21 CFR PART 11-compliant data: All temperature and humidity records can be validated.


• Redundant Data Storage: Each logger features on-board memory for data back up and archiving.


• Superior Accuracy: to ±1%RH and ±0.10°C; Precision: 0.05% RH and 0.05°C (at 25°C).


• Total immunity to network failures and power outages. Each Veriteq logger is powered by a 10-year battery life and standalone memory.


• Fail-safe Alarm Notification: 24/7 coverage with email to PC, pager, dial-out phone or cell.


• Quick & Easy Installation: Typically done in-house in less than an hour

Connect via WiFi, Wired or PoE

viewLinc™ Stability Chamber Monitoring System

• Precision temperature & humidity data loggers
• A2LA-accredited calibration certificate [PDF] (sample)
• Digi serial-to-Ethernet adapter and cabling
• 21 CFR Part 11-compliant reporting software [PDF]
• Real-time alarm monitoring software
• Perpetual software site license

For more information about our temperature monitoring and chamber monitoring solutions, please contact us or call 800-683-8374.