Guidelines On The Irradiation Of Fetal Bovine Serum
Gamma irradiation can be done to serum orders prior to shipping. See the bottom of this page for more details.
Gamma irradiation is the most commonly used method for viral inactivation of bovine serum as a means of obtaining a safe but biologically active product. High-energy photons are emitted from an isotope source that disrupts living cells by damaging DNA and other cellular structures, inactivating any potential microorganisms.
The ability to appropriately irradiate bovine serum depends on a number of complex factors including serum characteristics, design of the packaging, and volume of the serum. Gamma radiation of frozen bovine serum presents a unique challenge. Locating a dose measuring or dosimeter on the outside of the serum package container is not sufficient to determine how much radiation is received throughout the mass of the serum, only what was delivered to that location. Many dose measuring or dosimetry methods are influenced by temperature making the placement of the measuring device next to frozen bovine serum inaccurate. In addition, the amount of exposure is influenced by the time of radiation exposure near the source, the distance from the radiation source, and amount of shielding created by the packaging and serum itself. To overcome temperature and shielding issues, a reference dose mapping study is performed to demonstrate that a specified dose is received throughout the mass of the product while maintaining serum performance. A routine dosimeter system is used to measure to reference dose and determine the reference ratio. The reference ratios are used during routine processing to calculate the dose range that must be delivered to the reference dosimeter to achieve required internal minimum and maximum dose for frozen bovine serum.
At Atlas Biologicals we believe in a better serum. Information is gathered during our radiation validation process and available during supplier audits. Certificates of irradiation produced by our contract radiation facility and Atlas Biologicals are maintained with the device history file. If you have any further technical question please contact our Atlas Biologicals team at 866.222.8988 or [email protected]. We would be happy to assist you.