Electron Beam Processing Services

Introduction
RRCAT has set up an Electron Beam Radiation Processing Facility (EBPF) at Indore. The facility is based on two indigenously developed 10 MeV, 6 kW electron linear accelerators (linacs).

ARPF GenView

View of the facility building

EBeam Scanner

Electron beam scanners and product handling system in process chamber.

The capacity of the system is as follows:

Parameter Description	Value
Processing throughput	5 kGy.ton/hour
Dosage delivery capability (Minimum)	100 Gy
Dosage delivery capability (Maximum)	50 MGy
Typical Box/ Bag size that can be processed*. (Length x Width x Height)	60 cm x 45 cm x 35 cm
*The box dimensions can be adjusted according to product density. User's box size and internal device packing arrangement need to be discussed with process experts at EBPF

The above facility is available for sterilization of medical devices. Sterilization by electron beam is equivalent to sterilization carried out by gamma radiation. The sterilization dose required for electron beam and gamma radiation is identical (typically 25 kGy) as both have identical effect on microbial deactivation. Moreover, electron beam technology is eco-friendly, safe and is rising fast as it does not involve use of radioisotope (Cobalt-60) and radiation can be switched ON /OFF as per requirements. The dose rate in electron beam facility is very high due to which product hold time in irradiation zone (i.e., exposure time) is very less as compared to isotope-based facility.

The facility has the following licences and certifications:

1. AERB licence for facility operations. [pdf] (559.2 KB)

2. FDA licence for providing electron beam processing services for sterilization of class A medical devices. [pdf] (995.8 KB)

3. FDA licence for providing electron beam processing services for sterilization of class B medical devices. [pdf] (948.7 KB)

4. ISO 9001:2015 [pdf] (643.1 KB) and ISO 13485: 2016 [pdf] (643.4 KB) certifications for providing electron beam processing services for sterilization of medical devices as per the requirements of ISO 11137-1:2006/(R) 2010.

The product batch size can be customised to meet user requirements. The facility is open for irradiation of medical devices such as - Surgical Dressing Material, Catheter, Specimen Receptacles, Disposable Perfusion Sets, Umbilical Occlusion Device, Bolster Suture, Alcohol Swabs, and other non-notified medical products for which the FDA loan license is not required.

Invitation to use the facility:

AIC π-Hub invites service requests from Indian medical device manufacturers and industries for irradiation at the above-mentioned electron beam radiation processing facility. The services are being offered to various sectors as per the following rates.

#	Service	Dose, kGy^a	Processing Charges
1)	Irradiation service for Medical Devices Non-notified and Risk Class-A/B/C/D Pharmaceutical products	≥25	₹ 27.00 per kg
1)		≤15	₹ 16.20 per kg
2)	E-beam irradiation service for gem stones and other industrial products	Case-to-case basis	₹ 800/kW/hr

^a25 kGy and 15 kGy doses are to be provided depending on the initial bioburden in accordance with Standard ISO-11137. *GST and other taxes will be charged extra as per the prevailing rates and norms.

Interested medical device manufacturers may download Form to send their request: Service-Request-Form-EBPF and send the filled form to This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.

What is next?
On receipt of the filled service request form, Technology Development Team will proceed for "Client registration" and "dose mapping and feasibility study". The applicant needs to provide six boxes of product for dose qualification during dose mapping and feasibility evaluation. After confirming the feasibility, dose mapping number and product registration number will be generated. Subsequently, the applicant will submit "Loan Licence" from CDSCO (as per MDR-2017) and products to be processed along with the consent/order form for availing irradiation services. The applicant should ensure that the products delivered for irradiation conform to the issued service guidelines.

The above service is a part of our efforts to provide technology/ services to Indian entrepreneurs/ citizens and the decision of AIC π-Hub RRCAT shall be final in all respects.

Disclaimer:
RRCAT will take all precautions and follow practices to the best ability and knowledge, nevertheless RRCAT assume no liability for any damages, material or immaterial, that may arise from the irradiation of the product.