Gamma Radiation Sterilization
Almost all 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
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
The consignment should be submitted with a covering
order specifying the product detail and irradiation dose*
The irradiation charges are to be submitted at the
time of placing the order, unless alternate agreement is in place. The
charges vary from product to product, and you can have a quote for the
exact charges by. emailing our product detail to
Regulatory consent for drug items
For products that are under the purview of Drug
Control Authority, a 'Loan License' from the authority I and an
undertaking on prescribed format is a prerequisite
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
Industrial scale sterilization can be
done by several techniques such as dry heating, autoclaving (steam'
sterilization), gas sterilization (eg. 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. In products exposed to gamma rays from
Cobalt-60 source at the normally used dose level, there is no danger
of radioactivity or toxicity. Radiation processed products does not
become radioactive- just as our body do 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
- Sterilization of products of any shape can be achieved due to the
high penetration ability 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, which are
essentially batch processes.