Though sometimes used interchangeably, controlled room temperature and ambient temperature biostorage vary in terms of temperature and environment, regulations, and storage suitability.
What is Controlled Room Temperature?
Controlled room temperature, also called CRT, is not the same as “room temperature.” CRT, as its name suggests, is a controlled environment designed to maintain temperatures for storing sensitive materials.
CRT is defined by the United States Pharmacopeia (USP) as temperatures maintained between 20°C and 25°C. There are some excursions of plus or minus 5°C allowance outside of this range, for a wider scope of temperatures between 15°C and 30°C.
While the USP does permit this expanded temperature range, the overall mean kinetic temperature (MKT) should be 25°C. This means that while the temperature may vary over the length of time that materials are stored, 25°C should be the weighted average temperature to ensure stability, as higher temperatures have a more significant impact on degradation.
Since controlled room temperature is designed to hold a consistent temperature that is not affected by external conditions, CRT is suitable for a broad range of materials and products. This includes, among others:
- Pharmaceuticals
- Biologics
- Medical Devices
- Clinical trial materials
Additionally, CRT has an ideal humidity between 30% and 60%. For controlled room temperature storage, certain materials may have specific humidity requirements, so they may need to be stored in cleanrooms that maintain humidity between 30% and 40%.
Ambient Temperature Biostorage
Ambient temperature is the average of an environment and can be any temperature. This differs from room temperature, because room temperature pertains to a comfortable indoor temperature, while ambient is the actual temperature.
In the biopharmaceutical industry, ambient temperature is often between 15°C and 30°C (or 59°F to 86°F), but unlike controlled room temperature, there is no assured mean temperature or environment.
While ambient temperature biostorage is utilized, it has become less popular than controlled room temperature storage in recent years due to a lack of consistency. Still, ambient temperature storage is suitable for non-perishable items that withstand a variety of conditions without deterioration. For example, bulk storage for healthcare equipment and supplies, or stability storage testing.
Biopharma Storage Solutions
Controlled room temperature and ambient temperature biostorage are only two storage alternatives within a comprehensive scope of solutions. You may have various samples, ingredients, and products in need of storage, which involves cryogenic storage, ultra-low temperature storage, frozen storage, refrigerated storage, or even custom storage.
Get in touch with SciSafe through our contact form here to discuss how we can provide biopharmaceutical storage and cold chain logistics support.