- Radiation Sterilisation is a cold process that uses gamma radiation for sterilisation of Healthcare Products.
- Controlled gamma energy which is released by radioisotope such as Cobalt-60 is used for sterilisation.
- Cobalt-60 is most preferred radioisotope as it is readily available from single nuclear reaction in reactor and also cost effective.
- Gamma radiation is characterised by deep penetration and kills microorganism by destroying DNA structure.
- The process is suitable for Industrial scale sterilisation.
- Radiation dose of 25 kGy (2.5 Mrad) is officially accepted dose for sterilisation of healthcare products.
- Delivery of dose to the products is measured by dosimeter. Radiation sterilised products are acceptable by Food & Drug Administration (FDA).
Advantages and Benefits of Radiation Sterilization
(a) Products of any shape can be sterilised because powerful gamma rays can penetrate right through the package and the product.
(b) Being a cold process, heat sensitive plastic medical devices and pharmaceutical products can safely be sterilised.
(c) Flexibility in packaging, as the products can be packed individually in sealed bags and sterilised in the fully packaged form.
(d) Since sterilisation is effected after final packaging, product sterility is retained indefinitely provided the package is undamaged.
(e) Radiation Sterilisation enlarges the market for ready to use pre-packaged products. The process does not result into residual toxicity of any form in the product.
(f) Products sterilised by this process do not become radioactive and are safe for use.
Note: A Gamma Radiation Processing Facility is licensed by Atomic Energy Regulatory Board (AERB) and Local Food & Drug Administration (FDA).
- High energy Electron Beam (EB) and X-ray machines are also used nowadays for this purpose.
- The major difference in gamma radiation and EB lies in their penetration powers, where gamma radiations can penetrate deep inside the products the electron beams do not have as good penetration power.
- Though X-ray have comparable penetration power to gamma radiation at suitable energy range but they are not yet very popular.
- Board of Radiation and Isotope Technology (BRIT)/Department of Atomic Energy (DAE) had setup a radiation sterilisation plant ‘ISOMED’ which is in operation since 1974 for sterilisation of medical products.
- Technology has been found to be effective, reliable and acceptable among users.
(Note: This concept has high potential to be asked in UPSC Preliminary examination. Aspirants should make a note of it and include the same in their revision)