Objectives

The primary objective of this tender is to appoint a qualified service provider to design, upgrade, and modify the existing Grade C production facility into a cGMP-compliant Grade B facility. This involves the development of a fully compliant cleanroom environment, integration with existing infrastructure, and ensuring regulatory and safety standards are met to facilitate the production of aseptically prepared radiopharmaceuticals.

Scope

The scope includes:

• Design, supply, delivery, and installation of a cGMP-compliant cleanroom environment based on provided building layouts.
• Construction of a localized Grade B cleanroom zone surrounding two existing Grade B hot cells and one Grade A dispensing hot cell.
• Provision for entry and exit points, including cascade/change rooms, and dynamic personnel and material transfer systems supporting flow control.
• Modifications to existing facility structures to support compliance with upstream cascade behavior and radiological containment.
• Integration of HVAC systems with existing ventilation to maintain area classifications and containment requirements.
• Design of internal zoning, partitioning, finishes, and furniture suitable for pharmaceutical environments.
• Support for environmental control parameters such as temperature and humidity, with monitoring and alarm systems.
• Consideration of personnel movement, material flow, and safety interfaces within the design.

Technical Requirements

The technical scope mandates:

• Construction of a Grade B environment surrounding existing hot cells, with provisions for controlled entry/exit and cascade flow.
• Design of airflow, zoning, and partitioning to prevent cross-contamination and ensure unidirectional flow paths.
• Implementation of interlocking door systems suitable for cleanroom operation and cascade control.
• Provision for HVAC equipment integration to support area classifications and radiological containment, including cascade behavior from CNC to D, C, B, and A zones.
• Use of cleanable, non-shedding finishes for floors, walls, ceilings, and lighting.
• Design supporting operation by a maximum of four personnel within Grade B zones.
• Maintenance of environmental conditions: temperature at 20°C ± 2°C, relative humidity between 35-65%, with monitoring and alarm systems.
• Facility modifications to support radiological containment and safety requirements.

Skills and Skills Requirements

The successful bidder must demonstrate:

• Extensive experience in the design and construction of cGMP facilities, with a proven track record over at least 4 years, including providing company profiles, organograms, and key stakeholder details.
• Relevant references from the pharmaceutical or medical industry, with details of similar projects, project descriptions, contact persons, and project values.
• Capability to develop detailed project schedules from initiation to handover, with clear timelines and activity plans.
• Compliance with all URS requirements, including the use of the provided compliance matrix.
• Ability to provide qualified personnel with appropriate experience and training for design, construction, installation, commissioning, and validation activities.
• Knowledge of radiological containment, cleanroom standards, HVAC integration, and pharmaceutical environment requirements.
• Demonstrated understanding of regulatory compliance, safety standards, and environmental controls applicable to nuclear and pharmaceutical facilities.