This tender seeks a professional engineering firm to upgrade the NovaTec-P (Tc-99m) Generator Production Area and 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 facilitate the upgrade of the existing NovaTec-P (Tc-99m) Generator Production Area and its associated HVAC system. The scope includes comprehensive engineering design, project management, and compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements. Key deliverables will encompass the design and qualification of the upgraded facility, ensuring that all systems meet stringent quality and safety standards.
The project will involve upgrading critical areas such as the Preparation Area, Sterile Area, QC Elution Area, and Decon and Clearance Area, all of which must adhere to specific GMP classifications. The successful bidder will be responsible for conducting a thorough assessment of the current systems, proposing innovative solutions, and ensuring that the upgraded facility complies with all relevant health, safety, and environmental regulations. This upgrade is vital for enhancing the production capacity and maintaining the highest quality standards in the manufacture of sterile radiopharmaceuticals.
This tender is suitable for engineering firms with expertise in pharmaceutical manufacturing, HVAC systems, and compliance with GMP and regulatory standards. Companies experienced in project management and facility upgrades in the nuclear or medical sectors are encouraged to apply.