WHAT IS GAMMA IRRADIATION ?
Gamma rays are a form of electromagnetic radiation-like x-rays, but with higher energy. The primary industrial sources of gamma rays are radionuclide elements such as Cobalt 60, which emit gamma rays during radioactive decay. Gamma rays pass readily through plastics and kill bacteria by breaking the covalent bonds of bacterial DNA.
They are measured in units called kiloGrays (kGy).
Gamma irradiation provides a number of benefits in cost and sterility assurance. It can be applied under safe, welldefined, and controlled operating parameters, and is not a heat- or moisturegenerating process. Consequently, there is no heat stress and condensate drainage or outgassing is not required. Most importantly, there is no residual radioactivity after irradiation.
Gamma Radiation dose is validated according to IS. EN. ISO 11137-2 Method 1 to confirm the SAL 10-6. For that routine testing of bioburden & Sterility test carried out at our manufacturing facility.
VALIDITY OF STERILITY
We assure all sterile products have been sterile through Co-60 gamma radiation with valid certified dose and has been PASSED for all sterility tests. We confirm that the Sterile product would be Sterile until unless the packing pouch is not tampered/punctured/open or 5 yrs from date of Radiation.