Safety principle in the preparation of cefuroxime for intracamerular injection

S. Roche , K. Civiletti, O. Brocque, N. Mérité Service Pharmacie, Centre Hospitalier du Pays d’Aix, Aix en Provence, France

A monograph was added to the National Formulary in November 2009, indicating in its technical note that this preparation can only be made in authorised hospital pharmacies for reasons of asepsis and mastery of the risk of error. Our pharmacy is equipped with a clean room where each year we prepare 80,000 sterile injectable preparations, including since October 2009 nominative 1 mg syringes. The objective of this study was to set out all the elements enabling us to perform a parametric release of the batches by the environmental supervisions of our clean room and the various controls performed during the preparation.

Our 100 m² clean room is equipped with 6 microbiological safety work stations and with a hood with a horizontal laminar air flow. Between January and May 2010, we performed 953 microbiological controls (air, surfaces and gloves) spread over 21 points in the room in accordance with the ISO 14-644-1 standard and recorded 26 positive results, three of which were significant. These convincing results enabled us to conclude that the preparation of aseptic process is fully mastered in accordance with the Good Preparation Practices.

Mastery of the risk of error is represented by a set of controls during and upon completion of the preparation, including a double visual inspection at each stage, a macroscopic examination of the diluted solution and measurement of its osmolality to be compared to the target level as determined (313 to 338 mOsm/kg).

This quality assurance system around the preparation process, based on observance of the protocols as established and on the controls, enables us to perform the parametric release of batches of syringes and to conclude that the preparation is sterile. An inter-pharmacies convention is currently being drafted setting in particular the areas of responsibility of the two parties and the conditions of transport, the most sensitive stage of the process.

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