Performance qualification (PQ) of a new isolator for reconstitution of cytotoxics

J. Gotzamanis, G. Bouguéon, M. Sangnier, A. Berroneau, S. Crauste-Manciet
CHU de Bordeaux, France

The performance qualification (PQ) checks the performance of an installation in daily activity conditions. In our Sterile Medicines Production Unit, an isolator was replaced. Right then, a PQ was carried out by the supplier in order to validate the performance of the biodecontamination cycles of the isolator and the airlocks. The goal of this study was to perform a new PQ of these cycles 2 months later in order to control their effectiveness in routine activity, as well as the maintenance of a sterile environment in the isolator.

Materials and methods
15 surface samples from the isolator were realized by using contact plates at the least accessible places to the sterilizing agent, as well as an active air sample using an aerobiocollector. Plates were then stored in an oven for 2 days at 37° C and 5 days at room temperature. All these samples were fulfilled following a biodecontamination cycle, then repeated 18 days later to ensure that sterility was permanently maintained. At the same time, 6 strips containing Bacillus atropheus spores were introduced into 6 loads of material representative of daily activity into the 2 airlocks. After carrying out a biodecontamination cycle of each of these airlocks, the strips were inoculated in TSA media, and then placed into an oven at 37° C for 7 days. Simultaneously, a medial fill test (MFT) was also carried out by 3 different pharmacy technicians. For all the tests, positive and negative controls were performed. Finally, a particle count (0.5 and 5µm) was performed using a particle counter at the end of a day of activity.

Plates realized after the general biodecontamination cycle showed no growth of microorganisms, either for surface samples or for active air sampling. This confirmed the effectiveness of this biodecontamination cycle. There was also no growth observed on samples done 18 days after this cycle. The culture media containing the strips did not show any growth of microorganisms either, which attests that they have been eliminated by the airlock cycles. The 3 MFT were also negative. This means that all the components used for the preparation have been properly sterilized, and that technicians have not brought additional contamination by handling them. Surprisingly 45/m3 particles (5µm) were counted, which is over the limit of 20 for class A criteria at rest. We are in progress to find the origin of the problem which can be either an error of the sampling time or a real non conformity of the isolator.

The PQ validated the maintenance of the microbiological class. A new particle counting will be performed, by checking prodecures. We thus note that it is important to carry out a PQ in addition to the supplier’s one.

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