Objectives

The primary objective of this tender is to develop a comprehensive design for a new Radioiodine Active Pharmaceutical Ingredient (API) manufacturing facility for non-sterile I-131. The facility aims to support the production of activation I-131 API in compliance with current Good Manufacturing Practice (cGMP), Good Engineering Practice (GEP), and radiological safety standards. It seeks to establish a safe, compliant, and efficient environment for radiopharmaceutical manufacturing, including associated systems and support services.

Scope

The scope encompasses the design, development, and qualification of the Activation I-131 API Manufacturing Facility located in Building P1900 on the Necsa site at Pelindaba. It includes all systems, support services, and infrastructure necessary for production, excluding the hot cell production line, which will be supplied by a third-party specialist. The facility will produce non-sterile I-131 API, with specific requirements for radiological and chemical safety, environmental compliance, and GMP standards. The scope also covers associated areas such as storage, waste management, and ancillary facilities, as detailed in Appendix B and process flow diagrams.

Technical Requirements

The technical requirements specify that the facility must:

• Be designed and constructed in accordance with GEP, cGMP, and relevant safety standards, including compliance with national legislation and international guidelines.
• Include designated areas such as GMP classified zones (Grade D), storage, sampling, packaging, dispatch, and waste management zones, with appropriate environmental controls.
• Implement a pressure cascade system, unidirectional airflow, and HEPA/ULPA filtration to ensure environmental cleanliness and containment.
• Provide adequate segregation between radiological and non-radiological areas, with specific zoning and classification as per SHEQ-INS-8030 and ISO standards.
• Design HVAC systems for reliable operation, with monitoring, control, and integrity testing capabilities.
• Include systems for compressed air, process water, nitrogen, electrical supply, backup power, ICT, fire detection, and safety systems.
• Ensure surfaces, doors, windows, plumbing, and materials facilitate cleaning, disinfection, and containment.
• Support qualification activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Skills and Skills Requirements

The tender requires service providers and design engineers to possess:

• Expertise in pharmaceutical facility design, especially for radiopharmaceuticals and radioactive materials.
• Knowledge of GMP, GEP, and radiological safety standards, including ISO 14644, ISO 8573, and PIC/S guidelines.
• Experience in designing HVAC systems for controlled environments, including HEPA/ULPA filtration, pressure cascade, and contamination control.
• Capability to develop detailed process flow diagrams, layout plans, and HVAC schematic diagrams (Appendix D).
• Proficiency in qualification and validation processes, including DQ, IQ, OQ, and PQ, aligned with GMP requirements.
• Ability to integrate safety, environmental, and radiological monitoring systems, including BMS and RP systems.
• Competence in project management, documentation, change control, and compliance with national and international standards.