Documents to procure gamma irradiation chamber and license for operation in blood center.

Abstract

Graft-versus-host disease is a critical posttransplant complication, particularly affecting individuals with compromised immune systems. Patients undergoing bone marrow transplants, neonates receiving intrauterine transfusions, and those recipients of blood from first-degree relatives are vulnerable to this condition. The significance of efficient lymphocyte inactivation has driven the widespread adoption of Gamma Irradiation Chambers (GICs) utilizing radiation sources such as Cesium-137 (Cs-137) or Cobalt-60 (Co-60). However, the effective operation of these chambers is contingent on navigating a complex regulatory landscape (Cs-137 or Co-60 is commonly used as the source of gamma rays. The usual dose is 25 Gray [Gy] to 35 Gy [1 Gy = 100 rads], this dosage inactivates 85%-95% of lymphocytes in the blood components without any adverse effect on other cellular components of the blood). GIC unit mainly houses either Co-60 or Cs-137as radiation sources (model no BI-2000, BI-5000 mfr. by Board of Radiation and Isotope Technology with typical radioactivity ranging from tens to hundreds of terabecquerel. These units are also used in research institutions, hospitals, blood center, etc. A review of legal, regulatory, and policy aspects of the operation of GIC in India regarding its issues, challenges, and opportunities. We aimed to prepare a standard guidance document for GIC for a smooth process of the Atomic Energy Regulatory Board (AERB) licensing and equipment purchasing. The present article was written based on the experience of applying for GIC with AERB and recurrent support extended to colleagues in the fraternity. The documents prepared for licensing and various procedural steps involved in the same are included. Many documents and many days are required from procurement to the receipt of the license for operation GIC. At the same time, with very few user institutes and less number of experienced people in the country, it becomes difficult to find a proper method to approach the national government body. If blood center/radiological safety officer are properly trained as per the guidelines available, this can reduce man-days and facilitate the earliest operations.