Lok Sabha Question No. 1740 (UNSTARRED), answered on 2016-05-04
Subject: Atomic Material
Ministry: ATOMIC ENERGY
Asked by: BHOLA SINGH

## GOVERNMENT OF INDIA

## DEPARTMENT OF ATOMIC ENERGY LOK SABHA UNSTARRED QUESTION NO.1740 TO BE ANSWERED ON 04.05.2016

## ATOMIC MATERIAL

## 1740.  SHRI BHOLA SINGH

Will the PRIME MINISTER be pleased to state:

- (a) the details regarding radio sterilisation;
- (b) whether the Government has done any impact assessment of radio sterilisation for the future benefit of atomic energy; and
- (c) if so, the details thereof and if not, the reasons therefor?

## ANSWER

THE  MINISTER  OF  STATE  FOR  PERSONNEL,  PUBLIC  GRIEVANCES  & PENSIONS AND PRIME MINISTER'S OFFICE (Dr. JITENDRA SINGH) :

- (a) 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 Sterilisation

- (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  prepackaged 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.
- (g)  Presently out of 18 operating plants in Government/SemiGovernment/Private/Co-operative sectors, around 13 are also engaged in sterilisation of medical products.

## Major components of a Radiation Sterilisation Plant

- (i) A source of gamma radiation (Cobalt-60)
- (ii) A radiation processing cell (irradiation cell)
- (iii)  Product conveyors and control mechanisms
- (iv)  Safety devices and interlocks

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.

- (b) Board  of  Radiation  and  Isotope  Technology  (BRIT)/Department  of  Atomic Energy (DAE) has not carried out any impact assessment studies independently for Radiation Sterilisation of healthcare products.
- (c)      BRIT/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.  Later  two  more Radiation  Processing Plants one at  BRIT,  Vashi  Complex,  Navi  Mumbai  and other  at  Lasalgaon  near  Nashik  were  set  up  for  radiation  processing  of  food and allied products. Both these plants are operating and users of this radiation technology are regularly increasing. In view of this BRIT has not carried out any impact study independently. However, it is promoting setting up of commercial radiation  processing  plants  and  so  far  15  such  plants  are  commissioned  in Government/Semi-Government/Private/Co-operative Sectors excluding 3 plants of BRIT/DAE.  Thus, the use of this technology is found to be acceptable.

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