Today our topic of discussion is Chemical Ethylene Oxide.
Chemical Ethylene Oxide
The active agent of the gas sterilization process can be ethylene oxide or another highly volatile substance. The highly flammable and potentially explosive nature of such agents is a disadvantage unless they are mixed with suitable inert gases to reduce their highly toxic properties and the possibility of toxic residues remaining in treated materials.
The whole process is difficult to control and should only be considered if no other sterilization procedure can be used. It must only be carried out under the supervision of highly skilled staff.
The sterilizing efficiency of ethylene oxide depends on the concentration of the gas, the humidity, the time of exposure, the temperature, and the nature of the load.
After sterilization, time should be allowed for the elimination of residual sterilizing agents and other volatile residues, which should be confirmed by specific tests.
Radiation
Sterilization of certain active ingredients, drug products, and medical devices in their final container or package may be achieved by exposure to ionizing radiation in the form of gamma radiation from a suitable radioisotopic source such as “Co (cobalt 60) or of electrons energized by a suitable electron accelerator. Laws and regulations for protection against radiation must be respected.
Gamma radiation and electron beams are used to effect ionization of the molecules in organisms. Mutations are thus formed in the DNA and these reactions alter replication.These processes are very dangerous and only well- trained and experienced staff should decide upon the desirability of their use and should ensure monitoring of the processes.
Specially designed and purpose-built installations and equipment must be used. It is usual to select an absorbed radiation level of 25 kGy (2.5 Mrad), although other levels may be employed provided that they have been validated.
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