Storage conditions for pharmaceuticals and biological materials must adhere to precise regulations in order to protect these products and ensure their quality remains consistent. But you may not realize that there are several different temperature ranges used in biostorage — each with its own specific conditions and considerations. In today’s post, we’ll examine the options your cold storage facility may provide in greater detail so that you can make an informed decision when choosing the best option for your needs.
- Ambient Storage: Sometimes referred to as “room temperature storage,” the range for this type of temperature-controlled storage is typically anywhere from 15 degrees Celsius to 30 degrees Celsius. This type of storage is suitable for biological materials that contain a preservative (including alcohol, formalin, etc.), including specimens and tissue samples. In most cases, ambient storage is not recommended for samples that require the extraction of molecular data, though it may be possible to obtain DNA from certain types of preserved samples stored in this type of environment.
- Controlled Room Temperature (CRT) Storage: CRT refers to conditions that actually fall within the ambient storage temperature range, but this type of storage is more closely maintained and is considered to be customary for many types of biological materials. Specifically, CRT storage requires temperature maintenance of 20 degrees Celsius to 25 degrees Celsius. The temperatures for CRT storage cannot exceed that 25-degree mark, excepting spikes of up to 40 degrees Celsius for less than 24 hours. There are some pharmaceutical products and biological samples that should not be subjected to lower temperatures, as freezing could actually cause degradation.
- Refrigerated Storage: Refrigerated storage involves the storage of biological or pharmaceutical materials in temperatures ranging from 2 degrees to 8 degrees Celsius. Generally, this is used as a short-term storage option, particularly for enzymes, antibodies, and other biological reagents. That’s because these materials will remain viable under these refrigerated temperature conditions (when used within the recommended time frames), but will have their structural integrity compromised if they were frozen and thawed. This type of biostorage may also be referred to as “cold” storage, in some cases.
- Freezer Storage: The temperature range associated with freezer storage can span from -20 degrees Celsius to -40 degrees Celsius. This may also be referred to as “cold chain storage” at your biological pharmaceutical facility. This is the recommended temperature storage option for many different kinds of biological materials, including DNA and RNA (provided they have been suspended in the right type of solutions prior to being stored). This storage condition can be suitable for both short-term and long-term situations.
- Ultra-Low Freezer Storage: Ultra-low freezer storage involves the storage of materials in conditions of approximately -80 degrees Celsius, with an acceptable range of -70 to -93 degrees Celsius. This type of biostorage condition is often used for long-term situations, as this extremely low-temperature range can prevent degrading in many types of molecules (including proteins, nucleic acids, and more). While this storage option is recommended for its ability to protect these materials, it’s essential to consider how those materials are frozen and thawed to ensure quality control.
- Cryogenic Freezer Storage: Sometimes referred to as “vapor phase LN2” or simply as “LN2,” cryogenic freezer storage involves the coldest conditions for biological materials. These temperatures can range from -150 degrees Celsius to -190 degrees Celsius and below. This is typically the best option for long-term biostorage because it prevents any and all biological activity from occurring during storage; in other words, it will maintain the quality of these products. It’s also the best option for samples that cannot be mixed with a preventative product. Biologic materials like blood, tissues, and reproductive specimens, as well as clinical trial materials, should be stored in cryogenic containers that can be maintained at -150 degrees Celsius for at least 10 days. Under those conditions, this type of storage is really the only viable option.
Now that you know more about the specific types of biological storage options available to you, you can follow the best practices for your given application and make a decision that supports those regulations. For additional assistance, please contact us today.