Feedback from temporary relocation of a sterile production activity

5 October 2022

M. Sangnier, G. Bougueon, A. Berroneau, S. Crauste-Manciet
CHU de Bordeaux, France

Our University Hospital includes 3 sterile production units (SPU). On our site, during the replacement of a double isolator, part of the production (2 production workstations out of 6) had to be relocated to another SPU, and part produced under laminar flow cabinets (LFC), in unfavorable context of growing activity (+6% in 2021), an undersizing of our SPU, and staff tension (departure of qualified personnel, COVID wave...). The objective of this work was to establish an organization allowing to ensure continuity of the care ensuring preparation and personnel safety, then to evaluate this organization.
The method chosen consisted in multidisciplinary meetings integrating pharmacists (Ph), pharmacy technician (Pt), health manager, hygiene department, technical and biomedical department... Several scenarios were developed to anticipate malfunctions. A very precise planning and assignment of tasks was defined and communicated to the teams, with daily updates. For the assessment, we analyzed the management of unexpected events and our quality indicators. Concerning organization, two topical prevailed, on the one hand the preparation’s quality: we waited for the requalification of the clean area of class C and did not degrade the usual controls: analytical, environmental, release ... On the other hand the logistical aspects, we evaluated human resources (one Ph and two Pt sent to the other site ...), training needs (handling under LFC, training on the new isolator), material needs on the other site (double stock of products, protective equipment ...), moving of furniture, biocleaning, qualifications, inter-site transport with respect to the cold chain. An increase in advance prescription was requested from the clinical services. Finally, the post-evaluation showed a stability of our indicators: no increase of internal non-conformities was observed and no production was refused. Regarding unforeseen events, during previous months preceding the work, we were confronted with a very high level of absenteeism, which slowed down the anticipation. During the work phase, we were confronted with the arrival of a technician who was alone and under-equipped, with difficulties of inter-site transportation, with an underestimation of the work overload of the Ph: missions of the Ph delegated on the other site, and solicitations relating to the building site and the organization of the Ph present on site... These unforeseen events were all managed.

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