Application Tips & Case Examples

Overview

Temperature and humidity data gathered in pharmaceutical stability studies is fundamental to how a drug product is made, packaged, labeled, and sold. Pharmaceutical companies traditionally record this data through the use of local chart recorders or centralized data recording and reporting systems.

Challenge

If the recorded temperature or humidity data associated with each stability chamber is not accurate or complete, the credibility of the stability testing processs can be at risk - with potential huge liabilities. In particular, a problem many companies face is how to deal with "data gaps" where, for various reasons, the existing data collection systems stop taking readings - resulting in short periods of time where there is no temperature or humidity data available on the stability process.

Regardless of the system or method used (chart recorders or centralized systems), the potential for data gaps exists. These can be caused by a number of factors.

When using chart recorders, possible causes include:

• the chart paper is not changed in time
• one or more chart pens run out of ink
• a power outage or power disturbance of some kind has interrupted operation
• damage to the chart recorder mechanisms

With centralized data recording systems, possible causes include:

• Power outages
• Network failures
• Wire cuts
• Equipment relocation
• System viruses
• Computer crashes
• Component malfunctions
• Operator errors

Solution

To address the problem of "data gaps", Veriteq VL-series data loggers can, and are, being used effectively as "redundant" data collectors. In doing so, they effectively eliminate the possibility or potential of these costly missed readings. By collecting data in a completely independent manner from the main system, the redundant data logger can be called upon as a backup source to fill in any gaps that may occur as a result of failures with the main system.

Veriteq VL-series data loggers are ideal for redundant monitoring of stability chambers because of several factors:

• They are small and completely self-contained, allowing them to be placed unobtrusively in chambers without any wires
• They are self-powered and unaffected by power outages or power glitches, allowing them to continue to record while other equipment is disrupted
• They are highly accurate and stable, offering performance to 2%RH and 0.15°C
• They produce secure and unalterable data that is 21 CFR Part 11 compliant
• They have a large internal memory, allowing them to monitor for extended periods of time without any attention or maintenance
• They can operate reliably under a wide range of operating conditions
• They can be calibrated to match ICH stability standards

Tips for using Veriteq data loggers as redundant monitors

When using Veriteq VL-series data loggers as redundant data collectors, observe the following three steps:

1. Set the logger data collection method to "wrap". This setting will ensure that the data loggers will always retain a "sliding window" (e.g. the last four weeks) of data that can be relied upon to bridge any data gaps caused by a malfunction in the main data collection system.
2. Set the data logger's sample rate to ensure the logger can cover a sufficient period of time to ensure maximum possible coverage. The following chart lists the length of time that a VL-2000 temperature and relative humidity data logger can record data for before overwriting the oldest data:

   Sample Interval	Recording Span
   10 seconds	30 hours
   1 minute	7.4 days
   15 minutes	3.7 months
   1 hour	1.2 years
   3 hours	3.6 years

3. To ensure proper operation, periodically check the data logger in accordance with a standard SOP. Logger operation can be checked in a number of different ways:

• If there is a glass window or viewing port in the stability chamber, operators can view the real-time readings on the data logger wirelessly (without having to open up the chamber) using Veriteq's wireless infrared module
• The logger can be connected using a flat and thin interface cable that can be routed easily through a door seal without causing air gaps. This allows the operator to read or download data logger operation using a laptop computer
• If the process allows it, open the chamber periodically, remove the logger, download the information, then return the logger to the chamber
• If information from the data logger is required on a remote or on-going basis, operators can also connect the data logger to a existing computer network. This will allow remote reporting and notification of chamber conditions, including the status of the network itself, without affecting the data collection operation of the logger

For more information on using Veriteq data loggers as redundant monitors in your stability chambers, contact Veriteq.