Microbiological qualification of an automatic compounding system for the production of chemotherapy

Philippine Marque1, Ilhem Malagouen1, Isabelle Princet1, Sara Molignier1, Anne-Sophie Haverlan1
1 Pharmacy, CHU Poitiers, France

Activity of our cytotoxic pharmaceutical unity is increasing connected with development of patient’s care in day hospital and the diversity of molecules.
In response, an automatic compounding system has been acquired to ensure quality and security of production with constant workforce. The aim of this study was to qualify our robot by evaluating biocontamination through two tests: environmental microbiological controls and Media fill test (MFT).

Materials and Methods
Environmental microbiological controls
A plan of active air and surface sampling on critical areas in the robot enclosure (sedimentation agar, swabs) has been drawn up. Samples were collected over 5 days (including 3 days of the MFT) in the morning after cleaning, during and after the activity.
Media fill test
The robot process included two steps. The first step was the filling of a mother bag with thioglycolate broth. Then, this bag was distributed on various final containers. Three cycles per day during 3 days were carried out. For every cycle, 3 units of each final container (syringes, empty bags and infusors) were tested. The finished products were incubated 14 days: 7 days at 25°C and 7 days at 35°C. Everyday, a visual control was realized, searching turbidity (sign of microbial growth), compared with control containers (filled on laminar flow hood). At the end of this period, each final container was inoculated to verify the sterility.
Before realization of the MFT, a fertility test had been performed on the same batch of thioglycolate broth.

For the environmental microbiological controls, all active air samples were negative. Moreover, a very low inoculum was observed on some sedimentation agar and swabs collections but they disappeared after cleaning. All the highlighted germs were microorganisms of the skin flora.
Regarding the 81 preparations performed, no turbidity was observed during the 14 days and the results of the final inoculation confirmed these observations.

Our MFT was successfully completed since no contamination was observed. However, the results of the environmental controls demonstrated the importance for the robot operators to respect aseptic manipulation process.
To complete the qualification of our automatic compounding system, analytical assays and chemical contamination tests have been achieved. In order to maintain the efficiency and quality of the robot, these tests will be performed routinely: periodic validation by MFT once a year or to evaluate the operator’s ability to maintain sterility during manufacturing.

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