Analytical and gravimetric qualification of a chemotherapy production robot

Charly Paillat 1, Maïté Sangnier1, Laura Mérieux1, Ilhem Malagouen1, Guillaume Binson1, Isabelle Princet1, Anne-Sophie Haverlan1, Sara Binson1
1 CHU Poitiers, Pharmacy Department, 2 rue de la Milétrie, 86000 Poitiers, France

Background
In our university hospital, the production of anti-cancer chemotherapies is constantly increasing (more than 10% in 2 years).
Over the last few months, a staffing constraint led two problems: an increase in the occurrence of musculo-skeletal disorders and a delay in the availability of preparations.
We bought a semi-autonomous robot. It will allow the production of upstream-standardized campaigns optimizing the daily workflow efficiency while reducing the manual production.

Purpose
The aim of this study is to answer to the “Bonnes Pratiques de Préparation (BPP)” about the equipment performance qualification, first validating the reliability of the production process of the robot by an analytical and gravimetric study.

Material/Methods
We selected three molecules with different standard doses in various final containers to constitute a representative panel of the future production of the robot. Analytical qualification uses UV / Raman spectrophotometry (QCPrep®) to measure final preparations tested. We used an outdoor calibrated precision scale to validate the reliability of the gravimetric control as well as the accuracy of volumes collected by peristaltic pumps of the robot.
Performing the tests in triplicate ensures repeatability and reproducibility. For each molecule, we realized a daily campaign with three units for each standard dose. We repeated campaign three days in a row.
A protocol describes the different stages of production, successive weighing, and sampling to follow to conclude at qualification.

Results
An Excel file allows the analysis of the results obtained. The permissible error percentage stipulated is +/- 10%. The difference between the observed and theoretical concentrations, the percentage of deviation of the collected volumes and the mass variation of our containers are for the integrity of the nine campaigns in the predefined range of acceptability.

Discussion – Conclusion
Parallel studies of pump performance, gravimetric and analytic validate the reliability of the production process. There are no recommendations with specific regulations. The qualification plan developed is therefore one example among others. To continue the performance qualification, the microbiological study will be necessary to enable us to anticipate the production of chemotherapies in an automated way via a secure tool in conformity with the “BPP”.

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