Supplying, installing, commissioning and maintaining isolators for the cleanroom of Jessa Hospital

Government contract for the supply, installation, commissioning and maintenance for 8 years after a 2-year warranty period of insulators for the cleanroom of the hospital pharmacy of Jessa Hospital. Two (2) or three (3) isolators will be used for the aseptic manipulation, preparation and distribution of potentially toxic drugs (cytostatics, oncology monoclonal antibodies and “live” drugs (BCG bladder irrigation, autologous serum eye drops, GMOs and/or ATMPs)). The system's priority is to protect the operator and environment, without compromising aseptic processing, product quality and sterility requirements. These isolators will be operational in a class D cleanroom. The cleanroom is not yet operational, so we cannot yet estimate exactly how many devices are needed to make the intended number of preparations. This includes a mandatory option for one additional isolator. Two (2) isolators will be used for the aseptic manipulation, preparation and dispensing of non-toxic sterile drugs. For these, the priority is primarily on product protection and secondary on operator and environmental protection. These isolators will be operational in a class D cleanroom. The cleanroom is not yet operational, so we cannot yet estimate exactly how many devices are needed to make the intended number of preparations. This includes a mandatory option for one (1) isolator that will be used for the aseptic preparation of potentially toxic preparations in the context of clinical studies (IMPs, with the exception of GMOs and ATMPs). The system's priority is to protect the operator and environment, without compromising aseptic processing, product quality and sterility requirements. This isolator will be operational in a class D cleanroom. The insulator must be