Bioreduction is a general term for reducing the number of microorganisms, or bioburden, in a product, sometimes referred to as “killing bugs.” Sterilization is a special case of bioreduction that has specific requirements set by a regulatory body such as the FDA. If a product is labeled as “sterile”, it must meet those requirements.
If you would like to reduce the bioburden of a product but have no need to meet the requirements for the product to be “sterile,” a radiation dose can be applied to a product to lower that bioburden to some level. Even a low dose dramatically lowers the microbe level! The amount of radiation required is determined by the customer and their goal of the treatment.
In consultation with our Technical Consultants, we can provide input to the selection of dose, and microbial testing through a lab can validate the dose selection. Given the required bioreduction dose, E-BEAM will irradiate the product in the same manner as sterilization, but without the regulatory oversight of sterilization.
The irradiation is done by placing the case of product on our conveyor (without opening the case) and subjecting it to the application of dose. This only takes a few minutes with electron beam! Following irradiation, there is no quarantine required and the product is ready to ship immediately.
E-BEAM’s bioreduction process is used by many customers to manage the bioburden level in their products and raw materials. It may be just what you’re looking for.