12.04.2021
The production site for medicines, the clean rooms are the heart of the Hospital Pharmacy of the Cantonal Hospital Aarau. With the completion of sterile cleaning, a milestone has now been reached on the way to final commissioning.
The “enormous administrative effort” is the first thing site manager Andrin Sennhauser mentions to describe the challenge of building and qualifying the clean rooms of the hospital pharmacy at the Aarau Cantonal Hospital (KSA), Aarau, Switzerland. “There is no test, no measurement in existence, which is not required to be done,” says Sennhauser. In the case of the KSA Aarau Cantonal Hospital pharmacy, the documentation of the rectification of defects for the silicone joints and surfaces alone required more than 100 pages. For quality control assurance purposes, everything is recorded in writing. So when the clean rooms of the KSA Hospital are now finally sterilely cleaned, that is only one milestone on the way to final commissioning – but there are in fact rather several others, also.
To qualify the cleanrooms, four stages have to be undertaken, and to put it simply: before building construction commences, everything is checked “down to the last screw”, and also as to whether the plan exactly meets the requirements (design qualification). After building construction, a check is undertaken to verify whether everything has been built according to plan (Installation Qualification). For the technical installations, a functional qualification (Operation Qualification) is required. Finally, there is the Performance Qualification, i.e. whether the system delivers the specified intent. At the Aarau (KSA) Cantonal Hospital pharmacy, the highest requirements are for cytostatic agents, i.e. the individually tailored medicines for cancer therapy.
In total, the KSA-Aarau Cantonal Hospital clean rooms include four cleanliness zones. Medication production is conducted in the most sterile clean rooms of Zone ‘B’, with workbenches of the highest cleanliness level of ‘A’. To progress to ‘B’, staff members need to pass through- or climb over -Zones ‘D’ and ‘C. Staff are required then to climb over the benches. Between each Zone is a bench, which ensures that nothing from ‘D’ comes into contact with ‘C’, and certainly nothing from ‘C’ with ‘B’. For this purpose, new shoes – first blue, then green – and sometimes also new medical clothing is made ready at each threshold. At the end, a full body suit is provided. The production shoes are white.
After sterile cleaning, the clean rooms already prepared for subsequent operations. But it will require several months before these are actually operational. The handover of the clean rooms to the KSA hospital authorities is planned for the beginning of May. Performance qualification by the operator will follow in June. When all requirements are correctly met, drug production can start in the new clean rooms in September 2021.
