Preliminary Risk Assessment of the Design of Facilities for the Preparation of Advanced Therapy Medicinal Products

Objective
A project is underway in our hospital to establish temporary facilities for the reconstitution of Advanced Therapy Medicinal Products (ATMP), in response to increasing demands from physicians and clinical trial sponsors. These facilities will serve as an interim solution until the completion of a permanent ATMP unit planned for 2028.
The aim of this work is to carry out a preliminary risk assessment of the pharmaceutical circuit envisioned within these temporary premises, to identify critical steps and, where necessary, propose improvement measures.

Methods
A steering committee was established to design the layout of the temporary ATMP reconstitution unit, located in unoccupied areas of the hospital, in compliance with Good Preparation Practices, the guidelines of the French High Council for Biotechnology, and the recommendations of the French Society of Oncological Pharmacy.
A Failure Modes, Effects and Criticality Analysis (FMECA) was conducted by a multidisciplinary working group including pharmacists, technicians, a health executive, and a quality officer. The analysis followed each step of the logistical circuit for both personnel and products, from the reception of the ATMP in the hospital pharmacy to the dispensing of the reconstituted product.
Each failure mode was assessed using residual criticality (Cr), defined as: frequency × severity × level of control, and categorized into three levels: low Cr (< 40), moderate Cr (40–60), and high Cr (≥ 60), in order to identify the steps requiring corrective actions.

Results
The ATMP reconstitution unit will include eight rooms: a deconditioning area, a storage room, a product entry airlock, a personnel entry/exit airlock, a preparation room equipped with a hybrid isolator, a finished product exit airlock, a release and dispensing room, a waste area, and a room for cleaning equipment.
A total of 63 failure modes were identified. For each, potential control measures were proposed, including: qualification of rooms and equipment, drafting of specific internal procedures, staff training and certification, performing trial runs for each new ATMP, and cleaning between preparations.
Following the analysis, all failure modes were rated with a residual criticality score below 40, indicating that no additional measures beyond those already planned are currently required.

Discussion – Conclusion
This FMECA enabled the identification of critical steps in the ATMP process, the anticipation of appropriate control measures, and the prospective validation of the facility design and of the organizational plan. The FMECA results will be included in the authorization application file to begin ATMP reconstitution, submitted to the Regional Health Agency, thereby demonstrating risk control and expediting the start of activity.

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