This tender seeks a professional engineering services firm to upgrade the existing NovaTec-P (Tc-99m) Generator Production Area and its HVAC system, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards.
The South African Nuclear Energy Corporation is inviting bids for the appointment of a professional engineering services firm to undertake the upgrade of the NovaTec-P Generator Production Area and its associated HVAC system. This project aims to enhance the production capabilities for sterile NovaTec-P (Mo-99/Tc-99m) generators, which are critical for nuclear medicine applications. The scope includes design, construction, commissioning, and qualification of the upgraded facilities in compliance with current Good Manufacturing Practices (cGMP) and other relevant regulations.
The successful bidder will be responsible for ensuring that the upgraded production area meets stringent safety, health, and environmental standards. Key requirements include the installation of state-of-the-art HVAC systems, adherence to quality risk management protocols, and the integration of utilities and support systems. The project will also involve comprehensive testing and validation processes to ensure operational readiness and compliance with regulatory requirements. This upgrade is crucial for maintaining the quality and reliability of radiopharmaceuticals produced at the facility, ultimately contributing to improved patient care in nuclear medicine.
This tender is suitable for engineering firms with expertise in facility upgrades, HVAC systems, and compliance with pharmaceutical manufacturing standards, particularly those experienced in nuclear medicine environments.