Temperature and Humidity Mapping in Stability Rooms

Choosing the Proper Equipment for Pharmaceutical Stability Room Humidity and Temperature Mapping



Contact Us
stability room image
Choosing the right equipment for pharmaceutical stability room humidity and temperature mapping is crucial for ensuring compliance with regulatory requirements and maintaining product quality. This article discusses the importance of stability testing, the challenges in creating and maintaining controlled environments, and the three key parameters to consider. It explores various equipment options, including wired thermal systems, wireless data loggers, and wired combination sensors, highlighting their advantages and limitations. By carefully selecting accurate and reliable equipment, pharmaceutical companies can save time and resources while meeting regulatory standards.

Choosing the Proper Equipment for Pharmaceutical Stability Room Humidity and Temperature Mapping

Choosing the right equipment for pharmaceutical stability room humidity and temperature mapping is crucial for ensuring compliance with regulatory requirements and maintaining product quality. This article discusses the importance of stability testing, the challenges in creating and maintaining controlled environments, and the three key parameters to consider. It explores various equipment options, including wired thermal systems, wireless data loggers, and wired combination sensors, highlighting their advantages and limitations. By carefully selecting accurate and reliable equipment, pharmaceutical companies can save time and resources while meeting regulatory standards.

Pharmaceutical and biotechnology companies face immense pressure to comply with regulatory requirements in order to ensure consumer safety. Stability testing is a vital part of this process, as it exposes products to conditions that can impact their efficacy during the supply chain and determines shelf life. Maintaining precise humidity and temperature levels is crucial in these stability testing environments.

The regulatory bodies responsible for pharmaceutical safety, such as the US Food and Drug Administration (FDA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), define guidelines for stability testing. According to ICH guidelines, humidity should be within +/- 5%RH of the set point, while temperature should be within +/-2°C of the set point.

Creating and maintaining the desired environment involves considering three key parameters:

  • Control constancy
  • Uniformity
  • Sensor accuracy

Control constancy refers to the ability of the conditioning system to maintain consistent humidity and temperature. Uniformity ensures that gradients or variations do not occur within the controlled space. Sensor accuracy, especially for humidity measurement, is critical, as fewer high-quality humidity sensors are available compared to temperature sensors.

When choosing temperature and humidity mapping equipment, several factors should be considered. It is important to select equipment known for high accuracy, long-term stability, and the ability to operate and measure over a wide range of temperatures and humidity levels. Sensors should be easily calibrated against trusted references and have the capability to be calibrated or adjusted in the field. Durability is also essential for equipment that needs to be transported to different validation locations.

There are different methods for mapping stability rooms, including wired thermal systems, wireless data loggers, and wired combination sensors. Wired thermal systems utilize multiple high-accuracy temperature inputs and humidity sensors for reference, assuming constant dew point across the room. However, this method may overlook issues like moisture leakage or lapses in the water vapor barrier.

Wireless data loggers offer ease of use and flexibility but lack real-time monitoring capabilities. Data is recorded during stability tests and downloaded afterward, making it challenging to identify issues during testing. Wired combination sensors, although requiring slightly more setup time, provide real-time access to relative humidity and temperature data at each mapping point. They eliminate the need for frequent chamber disturbances and can be verified and calibrated in the field.

Typical sensor layout for a stability room:

GxP V Model
Sensors should be placed in typically known reduced air flow locations. This diagram may not be representative of actual chamber shelves, racks, or cages used to store samples. The table below describes actual sensor placement locations.
Sensor Number Location Sensor Number Location
1 Left Top Front 7 Right Bottom Front
2 Left Top Rear 8 Right Bottom Rear
3 Left Bottom Front 9 Center of Room - Right Top
4 Left Bottom Rear 10 Center of Room - Left Top
5 Right Top Front 11 Center of Room - Left Bottom
13 Proximity of Control Sensor
Sensors 1-8 will be placed approximately 24 inches (2 Feet) from the interior surface of the chamber.
Sensors 9-12 will be placed approximately 36 inches (3 Feet) from the interior surface of the chamber.

Contact us or Request a Quote

Contact our experienced engineers to discuss your application needs.