Renovating isolators without activity production interruption, a challenge which generates risks

14 October 2019

Marine Sitbon1, Laetitia Lê1,2, Hail Aboudagga1, Pascale Ponthou1, Aymeric Chastel1, Nathalie Valin1, Eric Caudron1,2
1 : Pharmacy department, Hôpital européen Georges Pompidou (AP-HP), Paris, France
2 : Lip(Sys)2 Pharmaceutical analytical chemistry, UFR de pharmacie, Université Paris Sud, Châtenay-Malabry, France

The Production and Control unit for cytotoxic drugs includes 4 double-posts isolators. The ageing of these isolators leads to an increase in breakdown and curative maintenance operations. In order to guarantee the quality of patient care, a project to renew the 4 isolators has been initiated. It’s essential to maintain the production activity during the renovation and the qualification periods. In order to anticipate dangerous situations and guarantee the quality of preparations and the continuity of the service c (between 110 and 130 preparations dispensed per days), an a priori risk analysis was carried out to identify the risks associated with these critical periods, (flows deterioration, working conditions, reduction of production capacity) and to develop an appropriate strategy to control these risks.

Materials and Methods
The renewal of isolators will take place in 2 phases with a change of isolators 2 by 2 over 2 separate work periods. This analysis was performed according to the methodology of global risk analysis (GRA) by a multidisciplinary group in 3 steps: 1/ identification of dangerous situations (GRA system), 2/ identification of accident scenarios (GRA scenario) and assessment of their criticality (by rating their severity and occurrence), 3/ development of an action plan to reduce identified risks

A total of 15 dangerous situations were identified (23 during the work period and 15 during the qualification period) and 38 accident scenarios were listed. After analysis of their criticality, 28.9% (n=11) of tolerable under control scenarios (C2) and 44.7% (n=17) of unacceptable scenarios (C3) presenting a major risk for the activity were identified. Therefore, 11 actions were planned (reorganization of staff/hours during the works and the qualification period, preparation of non-cytotoxic preparations in the preparatory). According to the projections expected, this action plan will guarantee the safety of our system with 100% of the C3 scenarios reduce to C1 (n=6) or to C2 (n=11) and 73% of the C2 scenarios reduced to C1 (n=8).

The GRA enabled us to exhaustively analyse risks associated with this particularly sensitive project and to identify underestimated or even omitted risks. Today this work continues in order to evaluate new risks associated with possible identified actions and to determine risk control indicators for each remaining C2 risks to guarantee preparations, staff and patient safety during this high-risk period.

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