Belgium – Insulators – Leveren, installeren, indienststellen en onderhouden van isolatoren voor de cleanroom van Jessa Ziekenhuis

Public contract for the supply, installation, commissioning, and maintenance for 8 years after a 2-year warranty period of isolators for the cleanroom of the hospital pharmacy of Jessa Ziekenhuis. Several isolators (3 to 5) will be used for the manipulation, preparation, and distribution of potentially toxic medicines (cytostatics, monoclonal antibodies, and “live” medicines (BCG bladder instillation, autologous serum eye drops, GMO’s and/or ATMP's). For these isolators, the priority is primarily operator and environmental protection and secondarily product protection. These isolators will be operational in a class D cleanroom. Two (2) isolators will be used for the manipulation, preparation, and distribution of non-toxic sterile medicines. For these, the priority is primarily product protection and secondarily operator and environmental protection. These isolators will be operational in a class D cleanroom. One (1) isolator will be used for preparations in the context of clinical studies. For this, the priority is primarily product protection and secondarily operator and environmental protection. This isolator will be operational in a class D cleanroom. The internal environment of all isolators and the ventilated material airlocks (MAL) must be able to be disinfected independently of each other by means of a built-in/integrated, automatic, and validated system that uses hydrogen peroxide (H2O2). The purchase of the hydrogen peroxide (H2O2) itself is part of this contract. We expect the successful supplier to deliver documents and support the hospital in the qualification process of the isolators (IQ, OQ, and PQ). In addition to the purchase and installation of these isolators, the contractor 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 lifespan of the equipment. Jessa Ziekenhuis, as a reference hospital, offers a wide range of innovative and high-quality medicine and patient care, in collaboration with the partner hospitals in the Andreaz hospital network. Jessa Ziekenhuis aims to provide warm care to the patient and their family and actively involve them; both in the individual care pathway 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, the construction of which has already started. According to the current project planning (as of 02/02/2026) and the agreements with the contractor for the construction of the cleanroom, the isolators in the production pharmacy must be delivered at the latest by 03/01/2028. The current contract therefore intersects with the contract of the general contractor for the construction of the cleanroom and must in no case delay or hinder it. Furthermore, the contractor must be able to use this new cleanroom as soon as possible in order to further optimize its operation and comply with the new regulatory framework. Compliance with the execution deadline is therefore essential for this contract.