Modernization of cytostatic preparation at the VFN: replacement of isolators as the first step of a larger renovation

The General University Hospital (VFN) replaced two isolators intended for the preparation of cytostatics. It was a relatively demanding logistical and organizational operation, during which it was necessary to coordinate the work of the technical department, the supplier, and the company's own operations with several oncology clinics - and at the same time ensure the replacement of cytostatics at the Thomayer University Hospital so that the replacement would not affect patient care.

Both replaced devices were practically at the end of their useful life. The department now has four isolators, two of which are completely new. The replacement is not an isolated step, but the first stage of a broader renovation and development of the entire workplace, which was supported by the hospital management. The next step will be the construction of a replacement facility and subsequent complete reconstruction. The goal is modernization, meeting the increasingly demanding requirements of the SÚKL and increasing the capacity for the preparation of cytostatics, which the hospital could also offer commercially in the future.

The seemingly simple "replacement of two insulators" thus hides a whole series of steps that were managed without any major impact on operations. The total shutdown lasted only five days.

What is an insulator and why does it matter?

An isolator is a closed workplace that physically separates medical personnel from the drug being prepared. In the case of cytostatics, this provides double protection: the pharmaceutical assistant is protected from the dangerous substance and at the same time the drug is protected from microbiological contamination.

The new devices belong to the ENVAIR CDC “F” series – vacuum isolators meeting the EU GMP Class A environmental quality with laminar airflow for safe aseptic handling of cytotoxic substances. The vacuum is key: all pressures inside are lower than the surrounding environment, so contaminated air cannot escape to the outside. The air in the working zone is repeatedly filtered through HEPA filters; in recirculation models, the blown air additionally passes through an activated carbon filter. The pharmaceutical assistant works through sleeve openings with replaceable gloves. The material enters the isolator through inlet chambers with timed electromagnetic blocking, which ensures that both sides of the chamber are never open at the same time. The devices are controlled via a PLC (Programmable Logic Controller), enable automatic leak testing and are designed for easy maintenance and safe replacement of the main filter.

Importance for traffic The General Hospital is one of the largest workplaces of its kind in the Czech Republic, which is why the modernization of cytostatic preparation is of fundamental importance. The larger internal space of the new isolators means more efficient work and higher capacity. Given that the number of drugs being prepared will continue to grow in the future, this is an investment that will directly affect the availability and continuity of oncological care.