Belgium – Building completion work – PKEA - Contract 01 - organization of the pharmacy / cleanroom section

Opportunity description

This contract is a mixed public contract whose purpose is the organization, fitting-out and equipping of the pharmacy / cleanroom section, including the associated technical rooms, within Klinik St. Josef in Saint-Vith. It comprises two works lots and one lot consisting mainly of supplies. The contract does not relate solely to the creation of a controlled cleanroom-type environment, but also to the complete fitting-out of the hospital pharmacy concerned, the cleanroom, their associated technical rooms, as well as the equipment, furniture, technical devices, connections, finishes and accessories necessary for their compliant, safe and operational functioning. The contract includes all works, supplies, services, constraints and resources necessary for the complete and compliant completion of the structures, premises, installations and equipment described in these Special Tender Specifications, in the technical clauses, plans, summary bill of quantities and other contract documents. The contract is divided into three lots: Lot 1 – Demolitions: comprising preparatory works, dismantling, demolitions, removals, temporary protections and all services necessary to clear the areas concerned by the works. Lot 2 – Finishing works and technical systems: comprising finishing works, special technical systems, equipment, fixed or integrated furniture and the devices necessary for fitting out the pharmacy, the cleanroom and their associated technical rooms. Lot 2 includes all provisions for pending work, openings, connections, adaptations, interfaces and coordination necessary for integrating the isolators covered by Lot 3, within the limits specified by the contract documents. Lot 3 – Isolators: comprising execution studies, supply, delivery, handling, installation, own connections, configuration, commissioning, testing, qualification, documentation, training, warranty and maintenance of the pharmaceutical preparation isolators, as well as all interface services necessary for their integration. Performance-based approach applicable to Lots 2 and 3: The technical specifications and schedule items relating to Lot 2 and Lot 3 are, as applicable, formulated in terms of performance to be achieved, functional requirements or a combination thereof with technical, construction and regulatory specifications. The minimum requirements, performance levels, results, tolerances, operating conditions, verification methods and supporting documents are specified in the technical clauses, plans, schedules and other contract documents. For Lots 2 and 3, the tenderer shall determine, size and include in its tender all execution studies, supplies, equipment, accessories, interfaces, works and ancillary services, adjustments, tests, inspections, qualifications, documents and other resources necessary to achieve and demonstrate the required performance and results. For Lot 3, this obligation covers in particular the execution design, sizing, configuration and functional integration of the isolators, as well as their compatibility with the installations and performance of Lot 2. The proposed solutions shall comply with the minimum requirements, architectural and technical constraints, applicable standards and regulations, good practice, as well as the operating conditions specific to a hospital pharmacy comprising a controlled environment and a cleanroom. The works will be carried out in an operating hospital environment. The contractor must therefore take into account the specific constraints related to continuity of care, maintenance of hospital activity, the safety of patients, staff and visitors, the protection of sensitive equipment, as well as the limitation of nuisances, dust, vibrations, technical interruptions and contamination risks. All services must be performed in accordance with good practice, applicable legal and regulatory requirements, standards in force and the requirements specific to hospital pharmacies and controlled environments. The cleanroom and the installations contributing to its performance must comply with the requirements defined by the Royal Decree of 30/09/2020, Annexes III, PICS guide relating to the proper preparation of sterile medicines, as specified in the technical clauses of the contract, as well as with the instructions of the Contracting Authority, the project designers, the safety and health coordinator and, where applicable, the inspection bodies. Lot 3 relating to isolators: The supply, specialized installation, commissioning and specific qualification of the pharmaceutical preparation isolators form part of this contract under Lot 3. The holders of Lots 2 and 3 shall coordinate the openings, provisions for pending work, utilities, connections, drainage, interfaces with air handling and other technical systems, construction adaptations, delivery and handling access, integrated testing and qualification operations. Demolitions: comprising preparatory works, dismantling, demolitions, removals, temporary protections and all services necessary to clear the areas concerned by the works. Finishing works and technical systems: comprising finishing works, special technical systems, equipment, fixed or integrated furniture and the devices necessary for fitting out the pharmacy, the cleanroom and their associated technical rooms. Lot 2 includes all provisions for pending work, openings, connections, adaptations, interfaces and coordination necessary for integrating the isolators covered by Lot 3, within the limits specified by the contract documents. Isolators: comprising execution studies, supply, delivery, handling, installation, own connections, configuration, commissioning, testing, qualification, documentation, training, warranty and maintenance of the pharmaceutical preparation isolators, as well as all interface services necessary for their integration. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.