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Denmark, Central Region is a planning to start the procurement of isolator technology. In that regard, the Central Region would like to invite potential tenderer for a technical dialogue on this topic.
Denmark, Central Region is a building, a new hospital pharmacy on same the location as Aarhus University Hospital. The new hospital pharmacy is expected to be in operation October 2023. The hospital pharmacy requires isolator technology for their versatile production which includes cytostatics, antibiotics, TPN and other aseptic products. To avoid exclusion of isolators due to inadequate requirements, Central Region, Denmark has chosen to host a dialogue for potential tenders. Because of the versatile production different isolator configurations are needed, but the following is required as a minimum:
• compliance with EU GMP,
• grade A classification in the isolator chamber with the external environment being classified as grade D,
• closed isolator system, unidirectional flow/laminar flow,
• safe transfer of products in and out of isolator without compromising the grade A classification,
• decontamination with VHP where needed,
• integration with the electronic production system BD Cato,
• integration of BD Cato includes a scale and a screen in the isolator chamber,
• FMS and particle sensor should be integratable.
Consideration of the ergonomic needs and comfort of the operators will also be vital. The hospital pharmacy wants a video demonstration of the isolator technology and a walk through of the specifications in order to prepare the best tender.