Stability Testing: Mapping, Qualification & Monitoring Temperature & Humidity

The Challenge of Stability Testing

Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts how pharmaceuticals are produced, packaged, labeled and sold. However, creating the exact environmental conditions in a stability test is a complex process, but necessary to comply with standards defined by regulatory bodies like ICH and the FDA as well as to ensure the safety and efficacy of pharmaceutical products.

If the data compiled during a stability study is inaccurate or incomplete, the credibility of the study is at risk and creates the potential for devastating liabilities and loss. Background knowledge of the basic attributes of sensors, their calibration details and the recording and reporting capabilities is helpful when deciding on a system for performing accurate, gap-free stability studies.

Sensors & Calibration: Crucial in Stability Testing

A sensor at a given point can record temperature and humidity, but there are other parameters that must be taken into account lest the data obtained comprise only evidence of conditions at that point. A truer picture is gained for the test environment by considering uniformity of conditions and calibration uncertainty of the measurement device.

To establish uniformity, mapping a stability chamber is necessary. To manage calibration uncertainty, Veriteq factors temperature non-uniformity into their calibration process. Before calibrating our humidity sensors, we perform a high-accuracy temperature calibration on every data recorder. Each recorder’s measured temperature is then able to compensate for chamber non-uniformity during RH calibration — greatly reducing this source of error.

Temperature Sensors

Temperature is an easier parameter to ensure because the sensors are generally quite accurate and easy to calibrate. Veriteq temperature sensors provide accuracy to ±0.10°C. Obtaining accurate humidity measurement is more complex because if your procedure requires that you cycle temperature and humidity, the humidity sensor has to be temperature-compensated for that range.

Humidity Sensors

Unless the humidity sensor is of superb quality and properly calibrated, it will degrade to the point where data obtained is inaccurate, often useless. Most humidity sensors are highly unstable, losing accuracy from the exposure that is part of any rigorous stability testing process. This is why humidity sensors must be regularly calibrated, to reduce the "drift" in accuracy that occurs with each stability study.

Calibration intervals will vary based on the type of sensor and the conditions of operation (range of temperature and humidity, atmospheric contaminants, etc). Veriteq humidity sensors are calibrated over a wide range of calibration point, and all factors on accuracy have been taken into account.

Immunizing Stability Studies from Data Gaps

A major issue in any validation process is the risk of "data gaps" in critical test procedures. This occurs when the existing data collection systems stop taking readings due to network or power failures. The result is short periods of time where no temperature or humidity data available on the stability process.

Regardless of the system or method used (both chart recorders and centralized systems share this vulnerability), the potential for data gaps exists.

In the case of chart recorders, possible causes of gaps in data include:

• Chart paper or ink runs out
• Power outage or disruption
• Undetected damage to the recorder mechanisms

With centralized data recording systems, data gap causes include:

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

The Gap-free Solution

To eliminate the risk of data gaps, Veriteq VL-series data loggers are "redundant" data collectors. Each device collects datd independently, with its own memory and power source. Used as a primary, or a secondary data collection system, the loggers can be called upon as a backup source to fill in any gaps that may occur as a result of infrastructure failures.

Ideal for Stability Studies

• Veriteq data loggers are small, completely self-contained and can be placed unobtrusively in chambers without any wires.
• The loggers are self-powered by a 10-year battery and unaffected by power glitches, allowing them to continue to record while other equipment is disrupted.
• Our sensors are highly accurate and stable, offering accuracy to +/-1%RH and +/-0.10°C.
• Fully validatable, our loggers produce secure and unalterable data that is 21 CFR Part 11 compliant.
• Each has a large internal memory and can monitor for extended periods of time.
• They operate reliably and measure accurately under a wide range of operating conditions.
• They can be calibrated to match ICH stability standards.

>> For more information on using Veriteq Monitoring & Validation systems for stability chambers and studies, please fill out the form or email us.

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