REQUEST FOR INFORMATION (RFI) ON THE PROVISION OF DESIGN SERVICES RELATED TO THE ESTABLISHMENT OF A NEW RADIOIODINE ACTIVE PHARMACEUTICAL INGREDIENT (API) FACILITYClosed

Overview

This tender seeks design services to establish a new Radioiodine Activation I-131 API manufacturing facility at Necsa/Pelindaba. Bidders should be engineering-design firms with radiopharmaceutical/facility experience, radiological safety expertise, and strong cGMP/compliance capabilities, including cleanroom/HVAC design and regulatory liaison (NTP-SPE-4162 Rev 2).

Requirements

• Proven design experience for radiopharmaceutical/API facilities, including hot cell interfaces and radiological waste management (NTP-SPE-4162 Rev 2)
• Knowledge of cGMP and PIC/S guidelines, SAHPRA requirements, ISO 14644 cleanroom standards, and HVAC design for nuclear facilities
• Ability to develop and manage design, installation, commissioning and qualification plans (DQ/IQ/OQ/PQ/C&Q) per ISPE guidelines
• Capability to integrate a Building Management System interface (BACnet/IP, Ethernet/IP) with local controllers (NTP-SPE-4162 Rev 2)
• Compliance with environmental, health and safety, hazardous substances and radiological controls, including ALARA principles
• Understanding of facility layout, material/personnel flows, transfer airlocks/MALs, and radiological area classifications

How to Apply

• Deadline: 22 July 2026 at 11:00; submission via electronic email to scm@necsa.co.za (RFI document)
• Briefing/workshop: on-site at Pelindaba (with online option on request); attendance is encouraged and linked to eligibility for the next bid phase (RFI document)
• What to provide: expression of interest and evidence of capability to bid in the subsequent design services tender (mandatory for progression) (RFI document)
• Source references: RFI scope and process details are in the Necsa RFI (REQUEST FOR INFORMATION...) and the facility design requirements are described in the URS for Activation I-131 Facility (NTP-SPE-4162 Rev 2)