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http://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=268769&B=REGIONMIDT
Udbyder
Region Midtjylland
Technical Dialogue — Isolator Technology
Region Midtjylland
Prior information notice
This notice is for prior information only
Supplies
Directive 2014/24/EU
Section I: Contracting authority
National registration number: 29190925
Postal address: Olof Palmes Allé 15
Town: Aarhus N
NUTS code: DK04
Postal code: 8200
Country: Denmark
Contact person: Christina Meiner Tästensen
E-mail: Christina.Meiner@stab.rm.dk
Telephone: +45 24976057
Internet address(es):
Main address: http://www.udbud.rm.dk
Address of the buyer profile: https://eu.eu-supply.com/ctm/Company/CompanyInformation/Index/253854
Section II: Object
Technical Dialogue — Isolator Technology
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.
Section IV: Procedure
Section VI: Complementary information
The technical dialogue will take place at meetings between interested tenderer and representatives from the hospital pharmacy and the Dept. of Procurement and Clinical Eng. The meetings will take place on
19-20 May 2020 and will be held by video conference. Registration must be submitted to public procurement consultant, Christina Meiner Tästensen, by e-mail to: christina.meiner@stab.rm.dk no later than 12 May 2020. After the last registration, further information will be sent out on the time of the meetings and details about the video conference.