PKEA - Market 01 - organization of the pharmacy cleanroom section

The Klinik Sankt Josef VoG in Belgium from Europe region has released this tender for This contract is a mixed public contract for the organization layout and equipping of the pharmacy cleanroom area including associated technical facilities within the St Josef Clinic in Saint-Vith It comprises two work packages and one primarily supply package The contract covers not only the creation of a controlled cleanroom environment but also the complete layout of the hospital pharmacy the cleanroom their associated technical facilities as well as the equipment furniture technical devices connections finishes and accessories necessary for their compliant safe and operational functioning The contract includes all the work supplies services constraints and resources necessary for the complete and compliant execution of the works premises installations and equipment described in this Special Specifications document the technical clauses the plans the summary bill of quantities and other contract documents The contract is divided into three lots Lot 1 Demolition including preparatory work dismantling demolition removal of debris temporary protection and all services necessary to clear the areas affected by the work Lot 2 Finishing and Technical Services including finishing work special technical services equipment fixed or integrated furniture and devices necessary for the fitting out of the pharmacy cleanroom and their associated technical facilities Lot 2 includes all the provisional reservation connection adaptation interface and coordination services necessary for the integration of the isolators covered by Lot 3 within the limits specified in the contract documents Lot 3 Isolators including the detailed design studies supply delivery handling installation proper connections configuration commissioning testing qualification documentation training warranty and maintenance of the 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 bills of quantities relating to lots 2 and 3 are as applicable formulated in terms of performance to be achieved functional requirements or a combination thereof with technical construction and regulatory requirements Minimum requirements performance levels results tolerances operating conditions verification methods and supporting documentation are specified in the technical clauses plans bills of quantities and other contract documents For lots 2 and 3 the bidder determines sizes and includes in its bid all execution studies supplies equipment accessories interfaces Ancillary works and services adjustments tests controls qualifications documentation and other resources necessary to achieve and demonstrate the required performance and results For Lot 3 this obligation notably covers the 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 comply with minimum requirements architectural and technical constraints applicable standards and regulations best practices and the specific operating conditions of a hospital pharmacy including a controlled environment and a cleanroom The work will be carried out in an active hospital environment The successful bidder must therefore take into account the specific constraints related to continuity of care maintaining hospital operations the safety of patients staff and visitors the protection of sensitive equipment and the limitation of nuisances dust vibrations technical interruptions and risks of contamination All services must be performed in accordance with best practices applicable legal and regulatory requirements current standards and the specific requirements of hospital pharmacies and controlled environments The cleanroom and the equipment contributing to its performance must comply with the requirements defined by the Royal Decree of 30 09 2020 Annex III PICS guide relating to the proper preparation of sterile medicinal products as specified in the technical clauses of the contract as well as the instructions of the Contracting Authority the project designers the health and safety coordinator and where applicable the inspection bodies Lot 3 relating to isolators The supply specialized installation commissioning and proper qualification of pharmaceutical preparation isolators are part of this contract under lot 3 The holders of lots 2 and 3 coordinate the reservations waiting supplies connections evacuations interfaces with air treatment and other techniques constructive adaptations delivery and handling access integrated tests and qualification operations The work will be carried out in accordance with best practices and the specific operating conditions of a hospital pharmacy including a controlled environment and a cleanroom The work will be performed within an active hospital environment The successful bidder must therefore take into account the specific constraints related to continuity of care maintaining hospital operations the safety of patients staff and visitors the protection of sensitive equipment and the minimization of nuisances dust vibrations technical interruptions and risks of contamination All services must be performed in accordance with best practices applicable legal and regulatory requirements current standards and the specific requirements of hospital pharmacies and controlled environments The cleanroom and the facilities contributing to its performance must comply with the requirements defined by the Royal Decree of 30 09 2020 Annex III PICS guide concerning the proper preparation of sterile medicinal products as specified in the technical clauses of the contract as well as the instructions of the Contracting Authority the project designers the health and safety coordinator and where applicable the inspection bodies Lot 3 relating to isolators The supply specialized installation commissioning and proper qualification of the pharmaceutical preparation isolators are included in this contract under Lot 3 The contractors for Lots 2 and 3 coordinate the reservations provisions power supplies connections drainage interfaces with air handling and other technologies construction adaptations delivery and handling access integrated testing and qualification operations The work will be carried out in accordance with best practices and the specific operating conditions of a hospital pharmacy including a controlled environment and a cleanroom The work will be performed within an active hospital environment The successful bidder must therefore take into account the specific constraints related to continuity of care maintaining hospital operations the safety of patients staff and visitors the protection of sensitive equipment and the minimization of nuisances dust vibrations technical interruptions and risks of contamination All services must be performed in accordance with best practices applicable legal and regulatory requirements current standards and the specific requirements of hospital pharmacies and controlled environments The cleanroom and the facilities contributing to its performance must comply with the requirements defined by the Royal Decree of 30 09 2020 Annex III PICS guide concerning the proper preparation of sterile medicinal products as specified in the technical clauses of the contract as well as the instructions of the Contracting Authority the project designers the health and safety coordinator and where applicable the inspection bodies Lot 3 relating to isolators The supply specialized installation commissioning and proper qualification of the pharmaceutical preparation isolators are included in this contract under Lot 3 The contractors for Lots 2 and 3 coordinate the reservations provisions power supplies connections drainage interfaces with air handling and other technologies construction adaptations delivery and handling access integrated testing and qualification operations Lot 3 relating to isolators The supply specialized installation commissioning and proper qualification of pharmaceutical preparation isolators are part of this contract under lot 3 The holders of lots 2 and 3 coordinate the reservations waiting supplies connections evacuations interfaces with air treatment and other techniques constructive adaptations delivery and handling access integrated tests and qualification operations Lot 3 relating to isolators The supply specialized installation commissioning and proper qualification of pharmaceutical preparation isolators are part of this contract under lot 3 The holders of lots 2 and 3 coordinate the reservations waiting supplies connections evacuations interfaces with air treatment and other techniques constructive adaptations delivery and handling access integrated tests and qualification operations with tender notice no. 666538-2026 published on 07 Oct 2026. The tender is due to expire on 28 Oct 2026. This tender is sourced from TED Europa and is eligible for suppliers interested in Building completion work. Interested bidders can obtain further information including complete bid documents or ways to participate by registering on Tender Impulse and referencing via Tender Impulse ID 15292843.