Belgium – Building completion work – PKEA - Marché 01 - organisation de la partie pharmacie / salle blanche

The present contract is a mixed public contract for the organisation, layout and equipment of the pharmacy/clean room section, including associated technical premises, at the Klinik St. Josef in Saint-Vith. It comprises two lots of works and one lot mainly of supplies. The contract does not only concern the creation of a controlled environment of the clean room type, but also the complete layout of the hospital pharmacy in question, the clean room, their associated technical premises, as well as the equipment, furniture, technical devices, connections, finishes and accessories necessary for their compliant, secure and operational functioning. The contract includes all the works, supplies, services, ancillaries and means necessary for the complete and compliant execution of the works, premises, installations and equipment described in the present Special Technical Clauses, in the technical clauses, the plans, the summary measurements and the other contract documents. The contract is divided into three lots:

Lot 1 – Demolitions: including preparatory works, dismantling, demolitions, removals, temporary protections and all services necessary for the release of the areas concerned by the works.

Lot 2 – Finishing and technical works: including finishing works, special techniques, equipment, fixed or integrated furniture and devices necessary for the layout of the pharmacy, the clean room and their associated technical premises. Lot 2 includes all the standby, reservation, connection, adaptation, interface and coordination services necessary for the integration of the isolators falling under Lot 3, within the limits specified by the contract documents.

Lot 3 – Isolators: including execution studies, supply, delivery, handling, installation, specific connections, parameter setting, commissioning, testing, qualification, documentation, training, warranty and maintenance of pharmaceutical preparation isolators, as well as all the interface services necessary for their integration.

Performance-based approach applicable to Lots 2 and 3: The technical specifications and the items of the schedules relating to Lot 2 and Lot 3 are, as the case may be, formulated in terms of performance to be achieved, functional requirements or a combination of these with technical, construction and normative specifications. The minimum requirements, performances, results, tolerances, operating conditions, verification methods and evidential documents are specified in the technical clauses, the plans, the schedules and the other contract documents. For Lots 2 and 3, the tenderer determines, sizes and includes in its offer all the execution studies, supplies, equipment, accessories, interfaces, works and ancillary services, adjustments, tests, checks, qualifications, documents and other means necessary to achieve and demonstrate the required performances and results. For Lot 3, this obligation covers in particular the design for execution, sizing, configuration and functional integration of the isolators as well as their compatibility with the installations and performances of Lot 2. The proposed solutions comply with the minimum requirements, architectural and technical constraints, applicable standards and regulations, rules of the art as well as the operating conditions specific to a hospital pharmacy comprising a controlled environment and a clean room. The works will be carried out in an active hospital environment. The contractor must therefore take into account the specific constraints related to the continuity of care, the 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 risks of contamination. All services must be carried out in accordance with the rules of the art, the applicable legal and regulatory provisions, the standards in force and the requirements specific to hospital pharmacies and controlled environments. The clean room and the installations that contribute to its performance must comply with the requirements defined by the AR 30/09/2020 Annexes III guide PICS relating to the good preparation of sterile medicines, as specified in the technical clauses of the contract, as well as the instructions of the Awarding Authority, the project authors, the safety and health coordinator and, where applicable, the control bodies.

Lot 3 relating to isolators: The supply, specialised installation, commissioning and specific qualification of pharmaceutical preparation isolators are part of the present contract under Lot 3. The holders of Lots 2 and 3 coordinate the reservations, standby, supplies, connections, evacuations, interfaces with air treatment and other techniques, structural adaptations, delivery and handling access, integrated tests and qualification operations.