I.1.1 Object / explanation project

Hospital network Helix, consisting of AZ Klina (Brasschaat), UZA (Edegem), AZ Monica (Antwerp), AZ Voorkempen (Malle) and AZ Rivierenland (Rumst and Bornem), has decided to build and operate a new state-of-the-art cleanroom in accordance with the PIC/S standards applicable from 01/01/2026 for hospital pharmacies. This cleanroom will be located on the site of AZ Klina.

The following preparations will be made in the new cleanroom: cytostatics, sterile preparations (including TPN preparations), magisterial stock preparations and chemo preparations within a study trajectory. In addition, medicines will also be repackaged.

Out of scope: magistrale niet-voorraadbereidingen en radiofarmaca.

For this first extensive cooperation project at network level, the network partners wish to call on external support to protect the interests of all sick people on the one hand. (see assignment documents)

Lot 1 concerns the appointment of a project coordinator, responsible for the general project coordination, guidance, follow-up and reporting, more specifically the organization, preparation, planning and realization of a timely delivery of the project within the fixed budget.

Furthermore, the following tasks also fall under the project follow-up (non-exhaustive)

• Escalations of any problems/necessary decisions if they occur;

• Provide input for specifications of specifications of specifications necessary for a good implementation (e.g. equipment, ICT,...);

• Possibly guiding discussions with potential partners during tender procedures for outsourcing (e.g. transport, cleaning, validation,...);

The provider is also expected to offer knowledge and expertise for the various areas of expertise (listed below, not exhaustively). The provider calls on a team of experts to ensure the progress of the project. The project coordinator manages the various teams for the various areas of expertise.

If the candidate wishes to call on subcontractors in this context, he is obliged to include the subcontractors in the application (cf. chapter I.5).

Lot 2 concerns the appointment of the "cleanroom expert" responsible for providing expertise regarding the operation, design (incl. follow-up execution) and operation of the state-of-the-art cleanroom.

The main tasks of the cleanroom expert are (non-exhaustive): drawing up the cleanroom processes (in the broad sense, e.g. including administrative processes), giving advice on their implementation and drawing up the technical specifications for the design of the hull.