Sterilization Radiation sterilization using gamma radiation is a well established industrial process in India. It is a very efficient and convenient technique for achieving a high level of sterility in medical supplies. Hermetically sealed medical products in cardboard cartons or aluminum tote boxes are generally exposed to a minimum dose of 25 kiloGray. Exposure of medical products, manufactured under Good manufacturing Practices (GMP), to minimum radiation dose of 25 kGy ensures sterility assurance level (SAL) of the order of 10-6 . This dose provides an extremely high safety factor, and when the product has low initial microbial count (<103 CFU per unit),the probability of any microbial survival can be expected to be less than one in one million.
Sterility Assurance Level
Food articles brought in for radiation processing shall be of good quality. 2. The facility shall be clean and shall have proper hygiene and sanitation and shall be free from cobweb, insect, cockroaches, rodents, etc. 3. The walls of the facility shall be free from seepage and capable of being kept clean. The flooring shall be smooth and even, and kept clean. The rooms of the facility shall be dust free. 4. The facility shall have adequate arrangements for light; control of temperature and humidity. 5. The incoming food material shall be properly stored and duly identified. 6. The unprocessed food material shall be separated from unprocessed food material by means of partition. 7. The workers employed in the facility shall be free from any infectious disease and shall wear clean apparel to be provided by the facility suitable for the work. Adequate facilities for personal cleanliness such as clean towels, soap, and wash premises shall be provided for workers. Separate provision shall be made for lavatories work shall be kept clean.
