MDI’s 3000 kCi Gamma Irradiation Facility
MDI State-of-The-Art Gamma Irradiation Facility, commissioned in 2024 is designed in compliance with AERB/RF-IRRAD/SS-6 (Rev.-1)-2007, “Radiological Safety for the Design & Installation of Land-based Stationary Gamma Irradiators.” This marks another significant milestone in our journey toward complete vertical integration. With this facility, MDI gains full control over the critical gamma sterilization process for MDI sterilizing filters and single use systems. This initiative strengthens our alignment with EU Annex 1 (2022) guidelines, which emphasize that filter and single-use system manufacturers must maintain in-depth knowledge and control over the sterilization process and facility.
These facilities are also available for gamma irradiation of:
- Healthcare Products
- Medical Devices
- Food Products
All critical validation activities for MDI filters and single use systems have been successfully completed in compliance with ISO 11137. This ensures consistent sterilization assurance levels while meeting global regulatory and quality expectations. This includes:
- Dose Substantiation
- Dose Mapping
- Sterilization Validation
Approvals
The facility has been validated by the Board of Radiation & Isotope Technology (BRIT) and approved by
- Atomic Energy Regulatory Board (AERB)
- Department of Atomic Energy (DAE)
- Food Safety and Standards Authority of India (FSSAI)
Certifications & Regulatory Status
- ISO 13485 (Medical Devices Quality Management System)
- CDSCO (Central Drugs Standard Control Organization) — Final Approval Awaited
- USFDA (United States Food and Drug Administration) — Registered (Certificate #: 2006080126)
Gamma Irradiation Services
MDI provides comprehensive Gamma Irradiation Services for a wide range of applications across healthcare, medical devices, pharmaceutical, biotechnology, and food industries.
With validated processes, regulatory approvals, and advanced quality systems, MDI is committed to delivering reliable, safe, and compliant gamma irradiation solutions tailored to customer requirements. MDI welcomes opportunities to collaborate with manufacturers and organizations requiring professional gamma irradiation services with:
- High Process Reliability
- Regulatory Compliance
- Reduced Turnaround Time
- Controlled Sterilization Processes
- Quality Documentation & Validation Support
Location Advantage
The facility is strategically located on the Panchkula–Shahbad National Highway, offering excellent accessibility and transportation connectivity.
Key Connectivity Highlights
- Just 3 km from the Amritsar–New Delhi Grand Trunk (GT) Road
- Easily approachable for logistics and industrial transportation
- Excellent connectivity for domestic and export operations
- Smooth access for northern India distribution networks
For irradiation service inquiries, partnerships, or technical discussions, please contact our team.