Belgium – Medical equipments – Isolator voor cytotoxische en monoclonale bereidingen

Subject of these deliveries: Isolator for cytotoxic and monoclonal preparations for the hospital pharmacy of AZ Jan Portaels. Supply, installation, commissioning (IQ/OQ/PQ) of isolator including all required works, services and testing. Explanation: The new hospital of AZ Jan Portaels is currently under full construction, delivery and occupancy is scheduled for 2027 (Range: 15/1/27 - 30/6/27). The tenderers in this tender take into account delivery and installation in the new hospital on the Salyx site, a former industrial site behind the station in Vilvoorde. At least the following elements are included in this contract (non-exhaustive): - acceptance of the equipment - supply and installation of the equipment - connection and testing of the equipment - equipment-specific adaptation works - documentation and training - service and maintenance Basic information about the desired Isolator, detailed information will follow in the 2nd phase: - Fully PIC/S & GMP compliant - Monopost with 2 gloves - Energy efficient (HVAC, lighting, ...) - Work surface inside the isolator completely made of 316L stainless steel - Safety glass, no plexi - RTP system for safe containers - Incoming airlock - workspace - outgoing airlock - 5-6 preparations in incoming airlock, max 20 minutes decontamination time guaranteed - 3-4 preparations outgoing airlock, max 15 minutes decontamination time guaranteed - Each airlock has an independent VHP, H2O2 generator - H2O2 and other consumables are freely available, not mandatory to purchase from the participant - Autonomy is important: e.g. user must be able to set positive, negative pressure via parameters without technician intervention. The content of H2O2 bottles can be monitored without a scale to avoid continuous calibrations - Unidirectional airflow - Air ducts at the back - Suitable for 12,500 - 15,000 preparations per year with active operation - Adjustable for ergonomic operation due to long preparation times, sufficient legroom and footrest are also applicable - Drugcam - Integrated touchscreen: touchscreen integrated in the setup but outside the isolator (no contact with hydrogen peroxide) - The participant will provide an airtight connection/coupling (external, e.g. via probe, sampling port) for particle counter type PMT APC Mini - Model: Dual Flow 28.3 & 100LPM - A240 for continuous monitoring, real-time ISO 5 control. - The participant will provide an airtight connection/coupling (external, e.g. via probe, sampling port) for air sampler type PMT BAS Pro - audit trail - Intercom - Quick interventions possible: intervention on-site within 4 hours is possible - Critical components and emergency H2O2 reserve in stock and available for intervention within 4 hours.