Overview
The pharmaceutical industry employs a wide variety of temperature and humidity chambers to perform various storage and testing functions. These chambers include environmental test chambers, stability chambers, calibration chambers, incubators, dessicators, and much more. On a regular basis these chambers need to be validated for the purposes they are intended to fulfill.
As a part of this validation process, the chambers are typically subjected to a series of periodic short-term tests designed to prove that the chambers can maintain the required temperature and humidity conditions inside - and that the conditions are evenly distributed throughout.
Traditional methods to map chambers have involved using bulky data acquisition systems connected to numerous thermocouple probes run through chamber doors. An easier and less disruptive solution is to use "wireless" data loggers such as Veriteq's VL-2000 temperature and humidity data loggers.
Challenge of environmental temperature monitoring
A challenge with using data loggers for mapping chambers, in comparison to using a traditional wired system, is how to monitor what's going on inside the chambers while the validation study is underway. This is important because if there is a problem inside the chamber that may invalidate the results, it is better to learn of this problem as soon as possible, rather than after the study is over.
Many data loggers can be connected with cables but running those cables through door seals can cause air gaps that serve to disrupt the conditions inside those chambers. What's needed is a "wireless" method of communications that can provide information on what's happening inside the chamber without disturbing the delicate temperature and humidity balance inside.
Solution
Many chambers have glass chamber doors or glass viewing ports. This makes them ideal for use with Veriteq's IR Interface Module which allows wireless data transmission through such mediums.
By interfacing to and monitoring at least one of the data loggers inside the chamber, operators outside the chamber can be reasonably certain that the chamber conditions are within specification, thus minimizing the possibility of having to repeat the validation later.
To use the IR Interface Module option, the chamber must have a clear glass window or door. If the chamber does not have a glass window, Veriteq offers a "flat cable" solution that can serve as an effective alternative with minimal disruption (contact Veriteq for more information).
Here are the basic steps to follow:
- Attach the IR Interface Module to a data logger inside the chamber.
- Position the data logger and module inside the chamber so that the IR window on the module is visible through the chamber window or glass door.
- Use a Palm handheld device with Veriteq sGo software to retrieve information from the data logger. This can be done by simply pointing at the module's IR window with the Palm handheld and pressing the Real-time button in Veriteq sGo.
Note that the communication range for IR communications is up to 1m (3 ft.).
|