Validation

Why Is Temperature Mapping Important for Biotech and Biopharmaceutical Products?

To Secure the Quality and Integrity of Products – Temperature Mapping is Crucial.

By Laura Hatchard

27 June 2023

Biopharmaceuticals and biotech products play a vital role in healthcare, scientific research, and the pharmaceutical industry. To make sure your products remain effective, it is essential to store them properly. That’s where temperature mapping comes in.

Temperature mapping, also known as thermal mapping, involves carefully monitoring and evaluating the temperature variations within fridges, freezers, and other temperature-sensitive environments. The goal is to ensure that medications and research samples are stored at correct temperatures, so they don’t degrade or get ruined. This not only keeps your consumers safe but also guarantees the reliability of scientific research.

The Role of Temperature Mapping

Temperature mapping and thermal mapping validation helps identify any temperature variations and hotspots that could potentially affect the quality of your products. By mapping the temperature distribution, you can take necessary actions like adjusting storage setups or upgrading equipment to ensure proper control and optimal conditions for your products.

What Happens if my Products are Stored Incorrectly?

Proper temperature storage is crucial for your biopharmaceutical and biotech products. Storing them in the wrong temperatures can lead to serious risks. If your fridge or freezer doesn’t work properly, it can affect the performance, effectiveness, and stability of your medical products.

When products are stored in incorrect temperatures, the chemicals within them can change, which can make them less effective or even harmful to patients. Moreover, relying on the “use-by” dates of medicines becomes unreliable if they are stored in faulty storage units.

Scientific research also relies on keeping samples and materials at specific temperatures. If items are not stored at the correct temperature, it can negatively impact the research results and render the samples unusable.

Carry Out Temperature Mapping Validation to Ensure Compliance

Pharmaceutical and Biotech companies need to prove that their equipment is functioning as intended to obtain license compliance. This process, known as temperature mapping validation, involves demonstrating that your storage and temperature-controlled equipment are operating within the required parameters.

By conducting this qualification temperature mapping, you can provide evidence that your equipment maintains the necessary temperature ranges. This proof is an important step in obtaining license compliance.

Ellab offers top-of-the-line equipment for conducting thermal mapping validation on your own, or if you prefer, our team of expert engineers can come to your site and handle the temperature mapping services for you. Whether you want to do it yourself or have our professionals take care of it, we have you covered with reliable solutions.