Germany - Laboratory apparatus, optical instruments and precision instruments (except glassware)

Description

The IKCL operates laboratory diagnostics at the Jena and Weimar sites. For the Jena site, two flow cytometers that can be used as backup are to be rented. The devices are to be used for clinical routine diagnostics as well as in the GMP-regulated environment for the testing of stem cell and lymphocyte preparations (including in-process controls in the manufacture of cell population-depleted preparations) (PART 1).From the time when the IVDR becomes mandatory, reagent kits certified in accordance with the IVDR must also be used for clinical routine diagnostics, which are intended for use on the rented flow cytometers (PART 2).
The flow cytometers are therefore put out to tender as PART 1 on the condition that the technical and regulatory requirements are met and that the device is suitable for the tests listed below and that the provision of corresponding IVDR-certified reagent kits analogous to the panels recommended by EuroFlow (or alternative panels of comparable diagnostic value) is already possible now or at least until the binding validity of the new IVDR.The reagent kits themselves are to be offered optionally as PART 2.Scope of services in PART 1 are:1. the ready-to-use provision (delivery, installation including qualification [IQ, OQ],2. set-up of the assays to be applied including associated evaluation templates) of two identical devices meeting the above requirements3. unidirectional connection to the Swisslab laboratory information system (transmission of test results, quality control data, user identification, batch information of the reagents used, if applicable).4. maintenance and technical support5. Continuous support by an application specialist for the implementation of new assays, the modification of existing assays as well as in case of analytical problems in routine operation is to be ensured over the contract period.6. Software, maintenance, emergency and training concepts (user training) as well as a concept for GMP / GCLP compliant raw data backup including a plan for the implementation of these concepts is to be submitted.7. Software updates which are necessary for the correct and IVD(R) compliant function of the software. However, due to the use of the analyzer systems in a GMP-regulated environment, a concrete installation of software updates may only take place after consultation with IKCL Jena. Reagent costs for the necessary requalification of the system after a corresponding software update are to be borne by the bidder.Scope of services in PART 2:Provision of all reagents, controls and consumables required for the parameter spectrum and the operation of the system in compliance with the specifications of RiliBäk.The tests must be CE-IVD labelled or comply with the IVDR as of its validity.

Opportunity closing date

25 October 2021

Value of contract

to be confirmed