This is not a contract notice, this is request for information to potential tenderers. The purpose of the information request is to inquire the market and gather information from both suppliers comments in order to implement a possible future call for tenders in an appropriate manner. The request for information does not solicit or provide tenders. Respondents to a request for information shall not be reimbursed for responding to the request for information, or participation in a possible market dialogue event. Responding to a request for information does not bind the supplier to participate in the tender, nor is it a condition Later to participate in the actual tender. Responding to a request for information or failure to reply shall not affect the tenderer's position in the actual invitation to tender. The purpose of the information request is to find out the features of the device, the need for maintenance, the price category and the Delivery time for a future call for tenders. This is not a contract notice, this is request for information to potential tenderers. The purpose of the information request is to inquire the market and gather information from both suppliers comments in order to implement a possible future call for tenders in an appropriate manner. The request for information does not solicit or provide tenders. Respondents to a request for information shall not be reimbursed for responding to the request for information, or participation in a possible market dialogue event. Responding to a request for information does not bind the supplier to participate in the tender, nor is it a condition later to participate in the actual tender. Responding to a request for information or failure to reply shall not affect the tenderer's position in the actual invitation to tender. The aim is to acquire a manual, semi-automatic or automatic device with attach and remove the needle or stopper of the 20 ml luer lock syringe. Object • manual, half-automatic or automatic appliance/device to connect and disconnect luer lock syringes with needle or cap. Requirements • appliance is needed to connect a luer lock syringe 20 ml (e.g. BD plastipak 20 ml luer lock) with a needle (e.g. BD Blunt fill 18 G, 25 mm) in an aseptic way to ensure sterility of the product. • appliance is needed to disconnect a luer lock syringe 20 ml (e.g. BD Plastipak 20 ml luer lock) and a needle (BD Blunt fill 18 G, 25 mm) in an aseptic way to ensure sterility of the product. • appliance is needed to connect luer lock syringe 20 ml (e.g. BD Plastipak 20 ml luer lock) with a luer lock cap (e.g. Combi-stopper or equivalent) in aseptic way to ensure sterility of the product. • the capacity of the appliance should be at minimum 10 connections per minute. Requirements for facilities • ISO 14644-1, 14644-2 (room), EN-12469:2000 (laminar flow); • GMP-cleanroom class A/B (
https://ec.europa.eu/health/documents/eudralex/vol-4_en). Requirements for components of the device • particle-free components; • non-porous surfaces (easy to clean); • components of device can be disconnected and cleaned separately; • disinfection with ethanol allowed; • steam sterilisation for most components; • electrical parts of the device have to be grounded; • operating voltage 230V/50Hz and/or compressed air (instrumental quality). Maximum size of the device • width max 600 mm; • height max 600 mm; • depth max 400 mm. Background • intravenous antimicrobials such as cefuroxime and piperacillin-tazobactam are prepared centrally with automation, which dissolves drug powder and draws the liquid into a syringe. About 400-500 syringes are prepared per day. • this appliance is needed to workflow in stages, which are now manually operated outside of the automation device: connection of a syringe and a needle, disconnection of a syringe and a needle and connection of a syringe and a cap. These stages are ergonomically challenging because of rotational motion of wrists about 1200 -1500 times per working day. The purpose of the information request is to find out the features of the device, the need for maintenance, the price category and the Delivery time for a future call for tenders. You can participate in the information request by email,
pekka.tiilikainen@sansia.fi