Understanding Temperature Mapping

Temperature mapping is an analysis performed on controlled temperature chambers (CTC). The term 'Controlled Temperature Chambers' encompasses a variety of equipment, including freezers, refrigerators, incubators, stability chambers, ovens, warehouses, cold rooms, or autoclaves. Each of these units maintain and control temperature or humidity and hence, must be temperature mapped. Temperature mapping essentially involves recording the temperature or humidity readings of multiple locations inside the equipment over a specified period of time.

The Crucial Role of Storage Temperature

Maintaining Product Quality

Storage temperature is highly significant in preserving the critical quality attributes of products. This is particularly true for drug products or samples that are temperature dependent. For these items, temperature must be well sustained and controlled.

Ensuring Compliance with Current Good Manufacturing Practices (cGMP)

Current Good Manufacturing Practices (cGMP) are guidelines that are required to be followed to maintain the products’ safety, quality, and efficacy. Compliance with these practices is mandatory.

Storage and Transportation: Necessity for Predetermined Conditions

Food and drug products must be stored and transported according to predetermined conditions such as a certain temperature range (for example, 2°C and 8°C). The distribution of these products must be undertaken in a manner that mitigates the risk of exposure to temperature excursions.

Recording Temperature or Humidity: The Process

To record the temperature or humidity, data loggers are placed in a uniform pattern across the three dimensions of your space – from top to bottom, left to right, front to back. These sensors are left in their location undisturbed for a specific period of time (typically 24 hours for a freezer, refrigerator, or incubator).

Understanding the Collected Data

The study will yield a representative view of the conditions inside of your controlled temperature chamber at that time. This data is then evaluated to determine if the recorded temperature conforms with the necessary tolerances or precise conditions required for the storage of samples, reagents, or drug product.

Temperature Mapping: An Integral Part of the Equipment Qualification Process

Temperature Mapping is a crucial component of the overall equipment qualification process for companies that operate in regulated environments. These companies apply Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to their processes.

The Challenges of Qualifying Controlled Temperature Chambers

Qualifying controlled temperature chambers presents a contradictory challenge to the validation technician. Each chamber qualification follows a seemingly simple framework, but the nuances of different chambers, manufacturers, temperature set points, alarms, automation systems, refrigeration, and heating systems require highly individualized methodologies. This brings an unexpected level of complexity to the task.

Diverse Temperature Behaviors and Challenges

Even when control is limited to temperature regulation, the individual nature of each chamber becomes apparent through qualification studies. Temperature stabilization and recovery periods can differ considerably across various refrigeration and heating systems, which can present a multitude of problems during mandatory temperature uniformity studies.

Automatic defrost cycles within a cold chamber can often cause unpredictable temperature spikes outside of the process range, negatively impacting product stability within the chamber. Also, different control systems may react to temperature changes in varied ways, requiring careful observation before a qualification study can begin.

Analysis of Safety Features and Building Automation Systems

Beyond the mechanical controls of the chamber, the safety features equipped with each unit need further analysis. These features ensure that the chamber responds appropriately in the event of equipment failure and resumes normal operation once the fault is cleared.

Building Automation Systems add another layer of complexity to the local alarm system, requiring a comprehensive test of all relays to ensure proper signal transmission to the monitoring software. When local and remote alarm systems operate independently of one another, any additional temperature probes must be individually calibrated and tested for proper function.

In Conclusion

Understanding the diverse nature of controlled temperature chambers is fundamental in temperature mapping. The value of our industry technicians lies in their adaptability to the individual operation of each chamber, effectively identifying and overcoming challenges in the qualification process while adhering to both regulations and the highest quality standards.

Temperature mapping is a critical step in the process of qualification and validation in pharmaceutical, biotechnology, and other regulated industries. By following the six key areas outlined in this article, you can effectively map temperature and ensure that your equipment and processes are in compliance with regulatory requirements.

Whether you are a seasoned professional or just starting out, the tools and templates provided in the "Six Steps to Effective Temperature Mapping" eBook can help you understand the key concepts and carry out temperature mapping with confidence.

So, if you're ready to become a temperature mapping expert, grab your copy of the eBook today and take the first step in your journey to success!

Order your copy now at https://www.tempmapp.com/temperature-mapping-ebook