• Category I: self contained dry storage
• Category II: panoramic dry storage
• Category III: self contained wet storage
• Category IV: panoramic wet storage

Gamma Irradiator Sources

• Co -60 (average photon energy: 1.25 MeV & half-life: 5.27 y used in almost all industrial radiation processing facilities)

• Cs –137 (photon energy: 661.7 keV & half-life: 30.1 y used in small, self-contained dry storage irradiators, for irradiation of blood and insect sterilization)

ISOMED – India's First gamma Radiation sterilization facility

• ISOMED the first radiation plant for sterilization of medical products, was set up in India in the year 1974 by Department of Atomic Energy at Trombay Mumbai with assistance of UNDP. Setting up of ISOMED had ushered in the radiation sterilization era in the country.

• In the last four decades of operation, ISOMED served over 1600 manufacturer of medical products and pharmaceuticals in the country.

ISOMETRIC VIEV OF ISOMED Plant

PRODUCT FLOW IN IRRADIATION CELLISOMED

ISOMED plant

• The Plant Essentially consists of
• Radiation source Co-60
• An automatic system for conveying the product boxes into the irradiation cell exposing to the radiation field for a specified period and taking them out of the cell
• Laboratory for dosimetry to release the processed product
• Facility for production of Radiation Indicator button

Procedure for radiation sterilization of licensed products

• Customer must have a valid manufacturing license issued by FDA/CDSCO for the products
• A Quality Agreement between ISOMED and Customer
• Customer must obtain a loan license in favor of IOSMED for the products intended to be sterilized by gamma radiation
• After scrutiny of application, ISOMED would issue a consent letter in prescribed form to the applicant to submit to CDSCO/state FDA for getting loan license.

Procedure for radiation sterilization of non licensed products

• Customer must have a valid manufacturing license issued by competent authority for the products
• A Quality Agreement between ISOMED and Manufacturer

Requirements for Sterilization by gamma radiation

AERB approved radiation facility

• Radiation Source (Co-60) to deliver desired radiation dose
• AERB approved staff
• Primary Packaging : The packaging should provide a complete barrier to the entry of microorganisms and should be designed to facilitate aseptic removal of contents. Unsupported PE films of 300 gauge thickness are suitable for soft products and 500 gauge for rigid products.

Radiation dose (kGy)

• The energy of radiation is deposited in medium when radiation passes through medium. Radiation energy absorbed is called radiation dose and is measured in Grey or kGrey
• Survival of micro-organism by radiation depend on D10 value of micro-organism, environmental conditions (humidity, temperature, water)
• Dose measurement - Chemical method:
• Ceric- cereous dosimetry system