Bid for the appointment of professional engineering services firm for the provision of upgrade of the existing NovaTec-P (Tc-99m) Generator Production Area and HVAC System.Closed

Overview

Procurement of a professional engineering services firm to design, manage and deliver the upgrade of the NovaTec-P Production Area and HVAC System (Tc-99m radiopharmaceutical generators) at NECSA/NTP. Bidders should offer engineering design and project management capabilities for GMP radiopharmaceutical facilities, aligned with the ECSA Professional Services Framework, and with experience in sterile processing, radiological safety, and regulatory compliance (cGMP, PIC/S, SAHPRA).

Requirements

• Proven experience in upgrading GMP sterile radiopharmaceutical production facilities and cleanrooms, with capability to deliver DQ/IQ/OQ/PQ (design, installation, operational, and performance qualification).
• Strong knowledge of and compliance with PIC/S Annex 1/Annex 15, ISO 14644 (cleanroom classifications), ISPE guides, PIC/S GMP for radiopharmaceuticals, SAHPRA guidelines, and WHO GMP references.
• Ability to integrate and qualify the complete HVAC, BMS, ICT, utilities (water, compressed air, power), fire and safety systems, and radiological controls; adherence to ALARA and radiological protection requirements.
• Access to and review of existing HVAC/design documentation under NDA; capability to develop basis-of-design, URS-derived requirements, and comprehensive C&Q deliverables.
• Demonstrated risk-based approach to scope definition, accreditation of facilities, and validation planning for direct-impact systems (generator production areas).

How to Apply

• Submission deadline: 2026-07-01 09:00; briefing: 2026-06-17 11:00; compulsory site access briefing at Pelindaba.
• Site access: forward ID copies of a representative to Fhatuwani.Mukwevho@ntp.co.za by 2026-06-09 16:00.
• Submission method: not specified in the metadata; obtain bid documents from the attached ZIP (FIN-SCM-TEN-0236.zip) and follow instructions therein.
• Documents to submit: refer to the bid documents in the ZIP; NDA is required to access current HVAC/design documents (see URS: “documents will be provided upon signing of an NDA” in RPH-SPE-3030 Rev 1).
• Pre-qualifications: confirm CIDB, tax clearance, and any CSD/CIDB requirements in the main bid documents (not explicitly listed in the URS); verify via the ZIP package.
• Briefing details: as above; venue: Pelindaba address provided in metadata.
• Where to obtain bid documents: from the ZIP file link in the tender metadata (FIN-SCM-TEN-0236.zip).