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Electron beam sterilization manual

Electron beam sterilization manual

Additionally, E-beam equipment does not incorporate any radioactive materials or isotopes requiring nuclear materialshandling licenses from agencies such as the U.S. Nuclear Regulatory Commission. SYST.
This effectively increases system throughput by 20. The transportation conveyor -powered either from overhead or on motorized rollers-moves the carriers into and out of the radiation shield, from the load station to the unload station.
Products are sterilized as they become available from the upstream production cycle, with no dose groupings or product staging necessary. For example, an E-beam system can make the transition from a product requiring a 25-kGy dose to a different product requiring an 18-kGy dose in.
Ultraviolet irradiation is not normally an acceptable method of sterilization. Prior to beginning a Process Validation Program for any product-specific radiation sterilization process, the following should exist and/or be done: the desired end-product (the pharmaceutical and its packaging) should be defined (specifications in terms of.
This guide is applicable to radiation processing only. While the principles outlined in this document are shared with other processes of sterilization, those processes require control and assessment of different parameters. It must be recognized that, regardless of the sterilization process, the control of manufacturing.
The initial high hopes for commercializing E-beam technology were short-lived due to the poor reliability of these early systems, and the opportunity for radiation sterilization of medical products was soon seized by cobalt 60 (gamma) irradiators, which had no similar reliability issues.
Conversely, an electron beam machine can deliver the same dose in a fraction of a second to a very small volume of product. These and other factors make it imperative that a product be validated independently for each source of radiation.
It is important to track the species as well as the number of organisms in order that the radiation dose delivered to the product continues to provide the same Sterility Assurance Level.