Equipment failure in a Controlled Atmosphere Zone (CAZ) : maintaining sterile drug preparations manufacturing

4 October 2023

A. Ghorbel, A.-C. Epinette, J. Delrieu
Centre Hospitalier Universitaire de Poitiers, France

Equipment failure leads to disruption of the production within a drug preparation unit. It does not guarantee compliance with the particulate and microbiological classes mentionned in the French Good Preparation Practices (BPP). In spite of the quality of the equipment available, we are not safe from a malfunction, which can have a direct impact on the patient.

To facilitate continuity of the activity, it is important to find degraded solutions that would still comply with the recommendations, whilst taking into account parameters like stock of hospital preparations, degree of emergency and patient management.

Equipments concerned by a possible breakdown are : air handling unit, vertical and horizontal unidirectional airflow stations. A screening of the BPP recommendations, in terms of microbiological and particulate contamination classes, was carried out for each preparation produced. An evaluation of the clinical impact of postponing manufacturing, according to different situations (therapeutic interest, potential patient impact) was decisive. An inventory of the equipment available in other pharmacy units, which comply with the particulate and microbiological classes we respect, was carried out.

Different flowcharts were created outlining the course of action to be taken. Multiple preparations were considered, notably parenteral nutrition, antibiotic/ciclosporin/atropine eye drops or autologous serum eye drops. Depending on the equipment concerned by the breakdown, solutions were: to postpone production, to transfer the activity to the Anticancer Drug Production (ADP) Unit, to call on a subcontractor, to manufacture by hand or to manufacture under the station that is not broken down. For example, if considering autologous serum eye drops, if a breakdown occurs on the vertical unidirectional airflow station, the production will be deported to the ADP Unit under unused for cytotoxics vertical unidirectional airflow station : thus, we have an acceptable regulatory alternative to avoid production postponing, so that the patient would not have his blood drawn again.

This work has highlighted the fact that anticipation is key when faced with an equipment breakdown in a CAZ for the production of magistral and hospital preparations. This having a direct consequence on patient management, the main goal is to limit this impact. Therefore, a degraded procedure has been drafted.

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