E-beam Sterilization : A Unique Opportunity For Indian Medical Device Industry

E-beam radiation refers to machine-generated high-energy electrons. As electrons have mass & charge, the penetration is limited in interaction material. The penetration depth is directly proportional to energy of electrons and inversely proportional to the density of the interacting material. The medical devices are normally made of low density materials, whose packaging density lies in the range of 0.1 to 0.2 g/cc. The 10 MeV electron beam has adequate penetration depth for medical devices. The penetration depth for two sided irradiation of these medical devices is typically 400 mm to 600 mm. However, the medical devices/ implants made of high density metals pose challenges for electron beam irradiation and need to be evaluated on case to case basis.

Are there any effect on polymeric components of medical devices exposed to e-beam sterilization particularly with respect to causing aging as compared to Gamma ray sterilization?

Electron beam is eco-friendly, secure and its application is increasing at a rapid rate. Sterilization by electron beam is equivalent to sterilization conventionally done by gamma radiation. Similar to gamma radiation, e-beam irradiation can influence properties of the polymers. In some polymers, electron beam cause cross linking at molecular level and enhance the molecular mass of the polymer. The three dimensional network formed by cross linking, improves mechanical properties (tensile strength, impact strength, toughness, wear resistance, temperature resistance etc.) to provide more stability to the medical device. For example, e-beam cross linked polymers are widely preferred for making knee and hip implants. In some polymeric material discolouration/degradation of material is observed with e-beam irradiation, as observed with gamma irradiation, but the magnitude of discolouration/degradation with e-beam irradiation is relatively low. The medical devices made of PVC, PMMA, polyethylene, polyamide, polycarbonate, polyester, polystyrene, polyurethanes, thermosets etc. exhibit good to excellent tolerance for e-beam irradiation in sterilization dose range 25 -50 kGy.

Please explain the formalities to be undergone by Industry particularly with respect to regulatory licences.

Medical device manufacturers willing to avail the e-beam radiation sterilization service can apply by sending the service request form to us. Subsequently RRCAT team will proceed for client registration and detailed product dose mapping & feasibility study. Once the product qualifies the feasibility study, a unique product registration number is issued to the client’s product which is used while bulk radiation processing of customer product.

From As per Medical Device Rule (MDR) 2017, client shall obtain “Loan License” from State FDA/CDSCO in Form no. MD-6 for Risk Class- A & B and submit the original copy to RRCAT to avail commercial irradiation service. RRCAT provide all possible guidance /support to client in obtaining loan license from FDA/CDSCO.

5 Medical devices standardised for E-beam sterilization

What kind of Medical Devices are compatible with e-beam sterilization?

Electron beam is eco- friendly and unlike EtO, does not leave any harmful residue in the sterilized product. Though e-beam can be used to sterilize all risk class A/B/C/D products. Currently, RRCAT facility provide sterilization service to Risk Class A & Risk Class-B products. Various kind of catheters, syringes, surgical dressings, gauge pieces, eye implants, collagen sheets, packaging material, body implants etc can be sterilized with electron beam. Detailed dose mapping study of each product is required for process development & validation before doing large scale commercial sterilization.

The first batch of 125 boxes of VTM tubes and Petri Dishes irradiated at ARPF

RRCAT has signed a MoU with med tech multinational company Becton Dickinson to sterilize their product Venflon Pro. The first consignment of 3.15 lakhs devices contained in 630 cartons were dispatched after sterilization on 20th October 2022. This public private partnership (PPP) will serve as a role model to transfer the benefits of indigenous developed technology to the common man to fulfill the dream of the Hon'ble Priminister's vision to make AtmNirbhar Bharat.