ML23318A028
| ML23318A028 | |
| Person / Time | |
|---|---|
| Issue date: | 11/14/2023 |
| From: | Torres M NRC/SECY |
| To: | |
| Shared Package | |
| ML23311A092 | List: |
| References | |
| M231116 | |
| Download: ML23318A028 (1) | |
Text
2 IV Solutions One Link Inter-Company Other Ext Set Date Site Opened: August 1976 Largest employer in Aibonito Footprint: 222K sq. ft. 246K sq. ft. Total site Employees: Approx. 1500 Key Products: OneLink, SVP Standard Solutions, Inter Company ViaFlex Containers, Molded/Extruded Components and Sub-Assemblies Manufacturing Technologies: Mixing/Filling, Extrusion, Molding, Automated Assemblies, Ultrasonic/RF Welding, Heat Sealing, Gamma Sterilization, Steam Sterilization Manufacturing Shift Structure : 24/6, 52 weeks
Nordion JS8900 Panoramic Wet Storage Industrial GAMMA Irradiator -
Carrier Type Regulated by the US Nuclear Regulatory Commission (NRC)
Built and Licensed in 1983 Largest Capacity Irradiator in the Caribbean ISOs 13485 and 11137 Certified Medical Devices and Sterilization Facility
Interactions and Relationship with the NRC
- License Requirements Compliance
- Radiation Safety Program Compliance (part 36 and 37)
- Security Aspects (largest irradiator in the Caribbean)
- Material transportation (sources addition, removal and decommission)
- Communications related to operational events, weather events, equipment upgrades or improvements
- Audits and Inspections
- Communications related to regulations changes
- Visits and Training Related Activities
Thank you for your attention!