Gamma Radiation Sterilization
Most of the Medical Products that are covered in schedule C and C1 are commonly sterilized by Gamma radiation. An indicative list of these products is given below:
- Surgical Disposables : Surgical Sutures, Bandages, Dressings, Gauge pads, Nappies, Delivery Kits etc, which are made of Cotton Wool and Gauge.
- Metallic Products: Surgical Blades, Needles, Implants, Aluminum Caps, Containers etc.
- Plastic And Rubber Items: Petri-dish, Centrifuge Tube, Blood Collection Sets, Scalp Vein Sets, Shunt Valves, Rubber Gloves, Contraceptive Devices, Gowns, Wraps Covers, Sheets, etc.
- Pharmaceuticals: Silver Sulphadiazene Cream, Gelatin Capsule, Bentonite Charcoal, Ergot Powder, Absorbable gelatin, Ophthalmic preparations in paraffin base and oil base, Skin Ointment in Polyethylene glycol base.
- Ayurvedic: Raw Materials, Herbs, Medicines, Granules.
- Spices : Whole and in Processed form.
Requirements of the Products for Irradiation
|Packing||To be packed in standard 5 ply corrugated card board cartons of outer dimension: 59cm L x 43cm x 33cm. (H)|
|Weight of box||For 25 kGy irradiation dose, (usually health care products), the maximum weight of the box should not exceed 15.0 kg.|
|For 15 kGy irradiation dose, (usually Herbal and Ayurvedic products) the maximum weight of the box can be upto 30.0 kg.|
|Documents||The consignment should be submitted with a covering order specifying the product detail and irradiation dose* requirement.|
|Charges||The charges vary from product to product, and you can have a quote for the exact charges by sending an e-mail to email@example.com|
|Regulatory consent for drug items||For Drug item (s) the customer should obtain regulatory approval in the name of SARC from Drugs Control Department Govt. of NCT of Delhi.|
|Any variation in the above parameters if required can be discussed before sending the consignment|
* The irradiation dose should be selected such that it is sufficient for effecting the expected benefits (sterilization, cross linking etc.) while the adverse effects (degradation, loss of medical efficacy, physical strength etc.) are minimal. If the optimal dose is not known, SARC can undertake dose optimization studies to help the new customers.
The Gamma Sterilization Advantage
Sterilization in an Industry can be done by several techniques such as Dry heating, Autoclaving (Steam sterilization), Gas sterilization (e.g. Ethylene oxide sterilization) etc., besides sterilization using Gamma rays. But the sterilization using Gamma rays has the following advantages:
- Unlike heat sterilization or steam sterilization, Gamma ray sterilization does not significantly increase the temperature of the products and therefore can be used to sterilize safely even the heat sensitive materials as well as materials in frozen condition.
- Unlike Ethylene oxide sterilization, Gamma sterilization does not leave any harmful residue. Products when exposed to Gamma rays from Cobalt-60 source at optimum dose level there is absolutely no danger of radioactivity or toxicity. Radiation processed products does not become radioactive as in similar case our body does not start emitting X -rays after being X-rayed.
- Gamma sterilization is performed after packaging of the products in the final containers and does not involve any aseptic handling. Product sterility is retained indefinitely, as long as the packaging is intact.
- Sterilization of products of any shape can be achieved due to the high penetrability of Gamma rays.
- Gamma ray sterilization is non-polluting, environment friendly process and since it is a continuous process, the results are more uniform than gas or high temperature sterilization.