ISOMED is the radiation sterilization facility for medical products at Trombay in Mumbai. It was the first of its kind radiation sterilization facility in Asia. The experience at ISOMED led BRIT to provide consultancy services for setting up radiation processing plants in private sector.
ISOMED - was set up in 1974 by the Department of Atomic Energy to provide gamma sterilization services to the manufacturers of healthcare products in the country. The advantages of radiation sterilization over conventional methods prompted a large number of manufacturers to use this technology. A wide range of healthcare products are being sterilized at ISOMED.
ISOMED has acquired compliance to ISO 9001:2008, ISO13485:2003, ISO 11137:2006, ISO 22000:2005 - HACCP and also features on the list of approved facilities of the European Union.
Table-1 Products Approved by FDA Maharashtra for Radiation Sterilization at ISOMED, Mumbai
Approved for routine radiation sterilization
- Bandages - crape, cotton crape, gauze
- Cotton - buds, pads and swab
- Dressings- paraffin gauze, shell and finger
- Gauze pads
- Kits- maternity, minor surgery & vasectomy
- Absorbable gelatin sponge
- Opthalmic ointments in paraffin base - atropine sulphate, chloramphenicol, gentamycin sulphate, tetracycline
- Skin ointments in PEG base - neomycin sulphate hydrocortisone acetate alpha chymotrypsin
- Sutures - Catgut, linen, polyester and silk
- Herbal and Ayurvedic products
- Contraceptives, Intrauterine devices
- Perfusion Sets
- Drugs, Pharmaceuticals and Veterinary drugs.
- Orthopaedic Products Bone grafts, Bone Implants, Bipolar, Nails (Tibia and Femur), Orthopaedic implants, A.M. Prosthesis
Approved for Export Purpose only
- Belladonna dry extract
- Ergot powder
- Hydrocortisone neomycin
- Rawolfia serpentina
Table- 2 Products which do not require FDA Approval
- Containers and Closures: Bottles, Bungs, Caps, Droppers, Petridish, Plugs,Spike Caps, Empty kajal barrels, Empty aluminium tubes
- Medical Accessories: Aprons, Drapes, Gloves, Mayo trolley cover
- Surgical Products:Blades, Gloves, Implants, Instruments and Tools
Board of Radiation & Isotope Technology
South Site, BARC
Mumbai- 400 085