Microbiological validation of aseptic injectables preparations (AIP) manufacturing process thanks to a validation kit

9 October 2015

M. Barral, C. Fayard, C. Martin, F. Serratrice Métropole Savoie Hospital
49, Avenue du Grand Port Aix les Bains, France
Tél: +33 6 59 69 79 42

Cytotoxic compounding exposes mainly either the operator to toxic risk or the final product to microbiological contamination. As the toxic risk was previously validated, our study focused on microbiological validation of our manufacturing process of AIP thanks to a validation kit.

We retrospectively analysed all the AIP made in 2013 in order to identify the main « manipulation-type » (MT). We distinguish 8 MT according to the type of vial (ready-to-use or powder for injection), the number of step and the type of medical devices used for the manipulation (syringes, air intake, etc.). For this study, we used the validation kits KLERKIT®, containing Tryptone Soya Broth (TSB) (1 × 100 mL sterile bag; 3 × 20 mL sterile empty glass vials; 1 × 50mL sterile vial; 1 × 10 mL sterile ampoule). The main 6 MT were realized by 3 operators for a total of 60 manipulations. A positive control sample (final product contamination with an E. Coli inoculum) and a negative control sample (TSB sterile bag) were realized for each MT. The MT were done in usual manipulation conditions under a vertical laminar flow hood.

Final products were incubated during 72h at 36°C and then during 11 days at 22.5°C. There was a contamination if a turbidity in the broth media was observed. A visual control was done once a day. Germ identification was realized for each positive result.

For all the 60 manipulations done, no contamination was observed.

This test a posteriori allows a microbiological validation of our manufacturing process for the MT tested. The expensive cost of the validation kit makes impossible a routine validation of our manufacturing process. It seems more relevant to regularly (once or twice a year) test the operators on one MT using this kit.

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