Belgium – Medical equipments – Leveren, installeren, indienststellen en onderhouden van twee bereidingsrobots voor de cleanroom van Jessa Ziekenhuis

Public contract for the supply, installation, commissioning and maintenance of two (2) robots for the automated preparation of sterile potentially toxic pharmaceutical preparations (cytostatics and monoclonal antibodies) for the new cleanroom of the hospital pharmacy. The automatic robots will be used to produce sterile, potentially toxic pharmaceutical preparations in a controlled environment. The robots must prepare sterile parenteral solutions aseptically using at least 1 robotic arm. The preparation steps must be controllable in various ways (e.g. by gravimetric control, image recognition (camera) and/or scanning). The air in the workzone must be HEPA-filtered, have negative pressure and be laminar. The workzone must comply with EU-GMP class A standards. According to the current schedule, these robots will be operational in a class C background environment (or less stringent if this can be demonstrated with sufficient and robust scientifically sound data). We expect the awarded supplier to fully execute the qualification process (IQ and OQ), incl. delivery of the necessary documents, and support the hospital in performing the PQ. In addition to the purchase and installation of these robots, the Contracting Authority will also enter into a maintenance contract for 8 years (after a 2-year warranty period). The offered maintenance contract can be extended later for the entire lifetime of the equipment. Jessa Hospital, as a reference hospital, offers a wide range of innovative and high-quality medicine and patient care, in collaboration with partner hospitals in the Andreaz hospital network. Jessa Hospital aims to provide warm care to the patient and the family and actively involve them; both in the individual care trajectory and in the hospital's policy. To continue to guarantee the best possible care in the future, it has been chosen to build a new cleanroom. According to the current project schedule (dd. 30/04/2026) and the agreements with the general contractor, the robot must be delivered to the production pharmacy at the latest on 03/01/2028. The current contract therefore intersects with the contract of the general contractor and may in no case delay or hinder it. Furthermore, the Contracting Authority itself must be able to use this new cleanroom as soon as possible in order to further optimise its operation and comply with the new regulatory framework. Compliance with the execution deadline is therefore essential for this contract.