Understand Temperature Mapping and Why It’s Important to You

Temperature mapping is important if you are in a regulated industry such as biotech, pharmaceuticals, or healthcare. You may be required to comply with accreditation processes or regulation guidelines to ensure your product safety. Even well-designed storage areas can have temperature fluctuations that affect products, and it is important to identify these. Controlled products need testing and documentation based on your company’s risk assessment, which considers the product sensitivity to temperature and its impact.

Knowing when to perform temperature mapping is important to ensure that temperature-sensitive products are stored and transported safely. Common situations when temperature mapping is necessary:

1. Qualification of new equipment – When critical equipment is installed, it goes through a standard qualification process to ensure that it functions as expected. Temperature mapping is included in this process.
2. Repaired equipment – When a unit is repaired, it should be tested to make sure that it functions correctly.
3. Relocated equipment – The relocation of equipment can significantly affect its performance. Temperature mapping is encouraged when the equipment is in its new location.
4. Periodic re-qualification – Sterilization instruments, such as autoclaves, require a re-qualification cycle of at least once a year. For storage areas, the frequency of re-qualification can vary depending on the type of storage, from twice a year to up to five years.
5. Testing based on external conditions – Storage areas such as warehouses can be affected by external conditions, particularly in extreme seasons. Seasonal mapping like winter warehouse mapping and summer warehouse mapping can help ensure that products are stored safely all year round.

Equipment that stores temperature-sensitive items such as freezers, refrigerators, incubators, and stability chambers require temperature mapping. This ensures that every point in the storage area is in the accepted temperature range – suitable for storing your valuable products.

If you store products in warehouses, these also require temperature mapping. By strategically placing sensors throughout the storage area, you can ensure that the temperature is consistent and within acceptable limits.

For anyone working with steam sterilization, temperature mapping is required to validate this process. Mapping in this instance, checks that the right temperature is reached in the autoclave to make sure the items being sterilized are safe to use.

When choosing someone to do temperature mapping for you, you need to think about the quality of their staff and equipment, how long it takes to do the work, and if they’re well-known in the industry. Ellab can do everything you need with their flexible service, which includes equipment, protocols, engineers, and a summary report, as well as options for validation equipment rentals or purchase.