Objectives

The primary objective of this tender is to appoint a service provider to design and upgrade the existing Grade C production facility into a cGMP-compliant Grade B facility. The upgrade aims to modernize layout, personnel and material flow, area classifications, surface finishes, and support systems to meet current regulatory standards, operational needs, and technological advancements. The project includes modifications to the Radiochemistry room and associated areas to establish a Grade B environment and improve cascading of personnel, ensuring compliance with cGMP, ISO standards, WHO, PIC/S, and SAHPRA guidelines.

Scope

The scope encompasses the upgrade of the existing P2000 Production Facility and HVAC system located in Building P2000 on the NECSA premises. It includes:

• Design, development, installation, and qualification of the upgraded facility and HVAC system.
• Modification of layout, area classifications, surface finishes, and support systems to achieve compliance with cGMP and regulatory standards.
• Enhancement of personnel and material flow, including the establishment of a Grade B Radiochemistry room and improved cascading.
• Qualification activities such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Exclusion of the Cyclotron technical area and hall upgrade from this scope.

The scope also involves assessing the existing systems, ensuring integration with existing services, and complying with relevant standards and guidelines.

Technical Requirements

The technical requirements include:

• Compliance with ISO 14644 standards for cleanroom classifications and air cleanliness.
• Design and qualification of HVAC systems capable of maintaining specified environmental conditions, including temperature, humidity, and air change rates.
• Implementation of pressure cascade controls to prevent contamination and radiological exposure, with pressure differentials of at least 10 Pa between adjacent areas.
• Construction materials that are durable, non-porous, easy to clean, and minimize particle generation, with stainless steel preferred.
• Surface finishes that are smooth, impermeable, and resistant to cleaning agents.
• Design of rooms, doors, windows, floors, sinks, drains, and services to facilitate cleaning, prevent contamination, and ensure safety.
• Integration of HVAC, fire detection, safety systems, lighting, electrical, and communication systems to support GMP operations.
• Provision for radiological protection, waste management, and effluent systems.
• Design of personnel change rooms, material/waste transfer chambers, and support areas to minimize contamination risks.
• Qualification and validation of all systems, with documentation and compliance with relevant standards and guidelines.

Skills Requirements

The prospective service provider must possess:

• Expertise in pharmaceutical facility design, especially for sterile and radiopharmaceutical environments.
• Proven experience in upgrading and qualifying GMP-compliant facilities and HVAC systems.
• Knowledge of ISO 14644, PIC/S, WHO GMP guidelines, and South African regulatory requirements.
• Capability to perform risk-based assessments and develop qualification protocols (DQ, IQ, OQ, PQ).
• Competence in designing cleanroom layouts, surface finishes, and support systems that meet stringent contamination control standards.
• Experience in integrating safety, radiological protection, waste management, and environmental controls into facility design.
• Qualified personnel for commissioning, validation, calibration, and documentation activities.
• Ability to provide training, handover documentation, and support for lifecycle management of the upgraded facility.